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1. CD8 T cell function and cross-reactivity explored by stepwise increased peptide-HLA versus TCR affinity

Author

Baumgaertner, P., Schmidt, J., Costa-Nunes, C.M., Bordry, N., Guillaume, P., Luescher, I., Speiser, D.E., Rufer, N., and Hebeisen, M.

Subjects
Epitopes, MART-1 Antigen, Neoplasms, Immunology, Histocompatibility Antigens Class II, Receptors, Antigen, T-Cell, Humans, Immunology and Allergy, CD8-Positive T-Lymphocytes, Peptides, NY-ESO-1, TCR-peptide-MHC affinity, cancer immunotherapy, human CD8 T cells, melan-A/MART-1, peptide-HLA binding affinity, vaccine peptide
Abstract

Recruitment and activation of CD8 T cells occur through specific triggering of T cell receptor (TCR) by peptide-bound human leucocyte antigen (HLA) ligands. Within the generated trimeric TCR-peptide:HLA complex, the molecular binding affinities between peptide and HLA, and between TCR and peptide:HLA both impact T cell functional outcomes. However, how their individual and combined effects modulate immunogenicity and overall T cell responsiveness has not been investigated systematically. Here, we established two panels of human tumor peptide variants differing in their affinity to HLA. For precise characterization, we developed the "blue peptide assay", an upgraded cell-based approach to measure the peptide:HLA affinity. These peptide variants were then used to investigate the cross-reactivity of tumor antigen-specific CD8 T cell clonotypes derived from blood of cancer patients after vaccination with either the native or an affinity-optimized Melan-A/MART-1 epitope, or isolated from tumor infiltrated lymph nodes (TILNs). Vaccines containing the native tumor epitope generated T cells with better functionality, and superior cross-reactivity against potential low affinity escape epitopes, as compared to T cells induced by vaccines containing an HLA affinity-optimized epitope. Comparatively, Melan-A/MART-1-specific TILN cells displayed functional and cross-reactive profiles that were heterogeneous and clonotype-dependent. Finally, we took advantage of a collection of T cells expressing affinity-optimized NY-ESO-1-specific TCRs to interrogate the individual and combined impact of peptide:HLA and TCR-pHLA affinities on overall CD8 T cell responses. We found profound and distinct effects of both biophysical parameters, with additive contributions and absence of hierarchical dominance. Altogether, the biological impact of peptide:HLA and TCR-pHLA affinities on T cell responses was carefully dissected in two antigenic systems, frequently targeted in human cancer immunotherapy. Our technology and stepwise comparison open new insights into the rational design and selection of vaccine-associated tumor-specific epitopes and highlight the functional and cross-reactivity profiles that endow T cells with best tumor control capacity.

Published
2022
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2. Heterogeneity of DKA incidence and age-specific clinical characteristics in children diagnosed with type 1 diabetes in the TEDDY Study

Author

Jacobsen, L.M., Vehik, K., Veijola, R., Warncke, K., Toppari, J., Steck, A.K., Gesualdo, P., Akolkar, B., Lundgren, M., Hagopian, W.A., She, J.X., Rewers, M., Ziegler, A.G., Krischer, J.P., Larsson, H.E., Haller, M.J., TEDDY Study Group (Gezginci, C., Heublein, A., Hummel, S., Knopff, A., Koch, C., Koletzko, S., Roth, R., Schmidt, J., Scholz, M., Stock, J., Wendel, L., and Winkler, C.)

Subjects
Advanced and Specialized Nursing, Diabetes Mellitus, Type 1, Endocrinology, Diabetes and Metabolism, Incidence, Internal Medicine, Age Factors, Humans, Insulin, Epidemiology/Health Services Research, Child, Diabetic Ketoacidosis
Abstract

OBJECTIVE The Environmental Determinants of Diabetes in the Young (TEDDY) study is uniquely capable of investigating age-specific differences associated with type 1 diabetes. Because age is a primary driver of heterogeneity in type 1 diabetes, we sought to characterize by age metabolic derangements prior to diagnosis and clinical features associated with diabetic ketoacidosis (DKA). RESEARCH DESIGN AND METHODS The 379 TEDDY children who developed type 1 diabetes were grouped by age at onset (0–4, 5–9, and 10–14 years; n = 142, 151, and 86, respectively) with comparisons of autoantibody profiles, HLAs, family history of diabetes, presence of DKA, symptomatology at onset, and adherence to TEDDY protocol. Time-varying analysis compared those with oral glucose tolerance test data with TEDDY children who did not progress to diabetes. RESULTS Increasing fasting glucose (hazard ratio [HR] 1.09 [95% CI 1.04–1.14]; P = 0.0003), stimulated glucose (HR 1.50 [1.42–1.59]; P < 0.0001), fasting insulin (HR 0.89 [0.83–0.95]; P = 0.0009), and glucose-to-insulin ratio (HR 1.29 [1.16–1.43]; P < 0.0001) were associated with risk of progression to type 1 diabetes. Younger children had fewer autoantibodies with more symptoms at diagnosis. Twenty-three children (6.1%) had DKA at onset, only 1 (0.97%) of 103 with and 22 (8.0%) of 276 children without a first-degree relative (FDR) with type 1 diabetes (P = 0.008). Children with DKA were more likely to be nonadherent to study protocol (P = 0.047), with longer duration between their last TEDDY evaluation and diagnosis (median 10.2 vs. 2.0 months without DKA; P < 0.001). CONCLUSIONS DKA at onset in TEDDY is uncommon, especially for FDRs. For those without familial risk, metabolic monitoring continues to provide a primary benefit of reduced DKA but requires regular follow-up. Clinical and laboratory features vary by age at onset, adding to the heterogeneity of type 1 diabetes.

Published
2022

3. The prognostic value of respiratory symptoms and performance status in ambulatory cancer patients and unsuspected pulmonary embolism; analysis of an international, prospective, observational cohort study

Author

Maraveyas, A., Kraaijpoel, N., Bozas, G., Huang, C., Mahe, I., Bertoletti, L., Bartels-Rutten, A., Beyer-Westendorf, J., Constans, J., Iosub, D., Couturaud, F., Munoz, A. J., Biosca, M., Lerede, T., van Es, N., Di Nisio, M., Accassat, S., Aquilanti, S., Assaf, J. D., Baars, J., Beenen, L. F. M., Bergmann, J. F., Caliandro, R., Carrier, M., Confrere, E., Desormais, I., Dublanchet, N., Endig, S., Falanga, A., Falvo, N., Ferrer Perez, A. I., Garcia Escobar, I., Gonzalez Santiago, S., Grange, C., Helfer, H., Kleinjan, A., Lalezari, F., de Magalhaes, E., Marten, S., Martinez del Prado, P., Otten, H. M., Paleiron, N., Perez Ramirez, S., Pinson, M., Piovella, F., Planquette, B., Rickles, F., Russi, I., Rutjes, A. W. S., Salgado Fernandez, M., Sanchez, O., Sevestre, M. A., Schmidt, J., Thaler, J., Torres Perez-Solero, G., Tromeur, C., Zumarraga Cuesta, A., Graduate School, Vascular Medicine, ACS - Pulmonary hypertension & thrombosis, ARD - Amsterdam Reproduction and Development, Radiology and Nuclear Medicine, ACS - Microcirculation, ANS - Neurovascular Disorders, and Medical Biology

Subjects
medicine.medical_specialty, ECOG Performance Status, Clinical prediction rule, Logistic regression, Risk Assessment, Cohort Studies, cancer associated thrombosis, clinical prediction rule, Risk Factors, Neoplasms, Internal medicine, medicine, Humans, unsuspected pulmonary embolism, Prospective Studies, incidental pulmonary embolism, Retrospective Studies, Performance status, business.industry, risk assessment model, Hematology, Prognosis, medicine.disease, Pulmonary embolism, Cohort, Ambulatory, Pulmonary Embolism, business, Cohort study
Abstract

Background Optimal risk stratification of unsuspected pulmonary embolism (UPE) in ambulatory cancer patients (ACPs) remains unclear. Existing clinical predictive rules (CPRs) are derived from retrospective databases and have limitations. The UPE registry is a prospective international registry with pre-specified characteristics of ACPs with a recent UPE. The aim of this study was to assess the utility of risk factors captured in the UPE registry in predicting proximate (30-, 90- and 180-day) mortality and how they performed when applied to an existing CPR. Objectives To evaluate risk factors for proximate mortality, overall survival, recurrent venous thromboembolism and major bleeding, in the patients enrolled in the UPE registry cohort. Methods Data from the 695 ACPs in this registry were subjected to multivariate logistic regression analyses to identify predictors independently associated with proximate mortality and overall survival. The most consistent predictors were applied to the Hull CPR, an existing 5-point prediction rule. Results The most consistent predictors of mortality were patient-reported respiratory symptoms within 14 days before, and ECOG performance status at the time of UPE. These predictors applied to the Hull-CPR produced a consistent correlation with proximate mortality and overall survival (area under the curve [AUC] = 0.70 [95% CI 0.63, 077], AUC = 0.65 [95% CI 0.60, 070], AUC = 0.64 [95% CI 0.59, 068], and AUC = 0.61, 95% CI 0.57, 0.65, respectively). Conclusion In ACPs with UPE, ECOG performance status logged contemporaneously to the UPE diagnosis and respiratory symptoms prior to UPE diagnosis can stratify mortality risk. When applied to the HULL-CPR these risk predictors confirmed the risk stratification clusters of low-intermediate and high-risk for proximate mortality as seen in the original derivation cohort.

Published
2021

5. Efficacy and safety of IVIG in CIDP: Combined data of the PRIMA and PATH studies

Author

Merkies, Ingemar S. J., van Schaik, Ivo N., Léger, Jean-Marc, Bril, Vera, van Geloven, Nan, Hartung, Hans-Peter, Lewis, Richard A., Sobue, Gen, Lawo, John-Philip, Durn, Billie L., Cornblath, David R., De Bleecker, Jan L., Sommer, Claudia, Robberecht, Wim, Saarela, Mika, Kamienowski, Jerzy, Stelmasiak, Zbigniew, Tackenberg, Björn, Mielke, Orell, Sabet, A., George, K., Roberts, L., Carne, R., Blum, S., Henderson, R., Van Damme, P., Demeestere, J., Larue, S., D'Amour, C., Kunc, P., Valis, M., Sussova, J., Kalous, T., Talab, R., Bednar, M., Toomsoo, T., Rubanovits, I., Gross-Paju, K., Sorro, U., Saarela, M., Auranen, M., Pouget, J., Attarian, S., Masson, G. Le, Wielanek-Bachelet, A., Desnuelle, C., Delmont, E., Clavelou, P., Aufauvre, D., Schmidt, J., Zschuentzsch, J., Sommer, C., Kramer, D., Hoffmann, O., Goerlitz, C., Haas, J., Chatzopoulos, M., Yoon, R., Gold, R., Berlit, P., Jaspert-Grehl, A., Liebetanz, D., Kutschenko, A., Stangel, M., Trebst, C., Baum, P., Bergh, F., Klehmet, J., Meisel, A., Klostermann, F., Oechtering, J., Lehmann, H., Schroeter, M., Hagenacker, T., Mueller, D., Sperfeld, A., Bethke, F., Drory, V., Algom, A., Yarnitsky, D., Murinson, B., Di Muzio, A., Ciccocioppo, F., Sorbi, S., Mata, S., Schenone, A., Grandis, M., Lauria, G., Cazzato, D., Antonini, G., Morino, S., Cocito, D., Zibetti, M., Yokota, T., Ohkubo, T., Kanda, T., Kawai, M., Kaida, K., Onoue, H., Kuwabara, S., Mori, M., Iijima, M., Ohyama, K., Baba, M., Tomiyama, M., Nishiyama, K., Akutsu, T., Yokoyama, K., Kanai, K., van Schaik, I. N., Eftimov, F., Notermans, N. C., Visser, N., Faber, C., Hoeijmakers, J., Rejdak, K., Chyrchel-Paszkiewicz, U., Casanovas Pons, C., Antonia, M., Gamez, J., Salvado, M., Infante, C. Marquez, Benitez, S., Lunn, M., Morrow, J., Gosal, D., Lavin, T., Melamed, I., Testori, A., Ajroud-Driss, S., Menichella, D., Simpson, E., Lai, E. Chi-Ho, Dimachkie, M., Barohn, R. J., Beydoun, S., Johl, H., Lange, D., Shtilbans, A., Muley, S., Ladha, S., Freimer, M., Kissel, J., Latov, N., Chin, R., Ubogu, E., Mumfrey, S., Rao, T., Macdonald, P., Sharma, K., Gonzalez, G., Allen, J., Walk, D., Hobson-Webb, L., Gable, K., De Bleecker, J. L., Robberecht, W., Franques, J., Léger, J. -M., Morales, R. Juntas, Nguento, A., Schrey, Ch., Kamienowski, J., Stelmasiak, Z., Zwolińska, G., Neurology, AII - Infectious diseases, ANS - Neuroinfection & -inflammation, CSL Behring, Neurologian yksikkö, Clinicum, Department of Food and Nutrition, and HUS Neurocenter

Subjects
Research Report, Male, Outcome Assessment, efficacy, Medizin, Chronic inflammatory demyelinating polyneuropathy, CIDP, IVIG, PATH, PRIMA, Neuroscience (all), Neurology (clinical), INFLAMMATORY DEMYELINATING POLYNEUROPATHY, 3124 Neurology and psychiatry, law.invention, Grip strength, 0302 clinical medicine, Randomized controlled trial, law, Interquartile range, hemic and lymphatic diseases, Outcome Assessment, Health Care, 80 and over, Medicine and Health Sciences, Prospective Studies, Chronic Inflammatory Demyelinating, Prospective cohort study, Aged, 80 and over, education.field_of_study, General Neuroscience, Immunoglobulins, Intravenous, Middle Aged, OPEN-LABEL, humanities, 3. Good health, PREVALENCE, Europe, 030220 oncology & carcinogenesis, Cohort, POLYRADICULONEUROPATHY, Female, Intravenous, Polyneuropathy, Life Sciences & Biomedicine, Adult, medicine.medical_specialty, Efficacy, Neuroscience(all), Population, Clinical Neurology, Immunoglobulins, MAINTENANCE TREATMENT, 03 medical and health sciences, Young Adult, Double-Blind Method, Internal medicine, medicine, Journal Article, Humans, Immunologic Factors, INTRAVENOUS IMMUNOGLOBULIN, Aged, Polyradiculoneuropathy, Chronic Inflammatory Demyelinating, education, Science & Technology, business.industry, Neurosciences, 3112 Neurosciences, Research Reports, medicine.disease, PHASE-III, Health Care, cidp, ivig, path, prima, Neurosciences & Neurology, business, 030217 neurology & neurosurgery
Abstract

PRIMA Trial Investigators and the PATH Study Group., Intravenous immunoglobulin (IVIG) is a potential therapy for chronic inflammatory demyelinating polyneuropathy (CIDP). To investigate the efficacy and safety of the IVIG IgPro10 (Privigen) for treatment of CIDP, results from Privigen Impact on Mobility and Autonomy (PRIMA), a prospective, open‐label, single‐arm study of IVIG in immunoglobulin (Ig)‐naïve or IVIG pre‐treated subjects (NCT01184846, n = 28) and Polyneuropathy And Treatment with Hizentra (PATH), a double‐blind, randomized study including an open‐label, single‐arm IVIG phase in IVIG pre‐treated subjects (NCT01545076, IVIG restabilization phase n = 207) were analyzed separately and together (n = 235). Efficacy assessments included change in adjusted inflammatory neuropathy cause and treatment (INCAT) score, grip strength and Medical Research Council (MRC) sum score. Adverse drug reactions (ADRs) and ADRs/infusion were recorded. Adjusted INCAT response rate was 60.7% in all PRIMA subjects at Week 25 (76.9% in IVIG pre‐treated subjects) and 72.9% in PATH. In the pooled cohort (n = 235), INCAT response rate was 71.5%; median time to INCAT improvement was 4.3 weeks. No clear demographic differences were noticed between early (responding before Week 7, n = 148) and late responders (n = 21). In the pooled cohort, median change from baseline to last observation was −1.0 (interquartile range −2.0; 0.0) point for INCAT score; +8.0 (0.0; 20.0) kPa for maximum grip strength; +3.0 (1.0; 7.0) points for MRC sum score. In the pooled cohort, 271 ADRs were reported in 105 subjects (44.7%), a rate of 0.144 ADRs per infusion. This analysis confirms the efficacy and safety of IgPro10, a recently FDA‐approved IVIG for CIDP, in a population of mainly pre‐treated subjects with CIDP [Correction added on 14 March 2019 after first online publication: the INCAT response rate has been corrected.].

Published
2019

6. Edoxaban for the treatment of cancer-associated venous thromboembolism

Author

Raskob, GE, van Es, N, Verhamme, P, Carrier, M, Di Nisio, M, Garcia, D, Grosso, MA, Kakkar, AK, Kovacs, MJ, Mercuri, MF, Meyer, G, Segers, A, Shi, M, Wang, TF, Yeo, E, Zhang, G, Zwicker, JI, Weitz, JI, Büller, HR, Beyer-Westendorf, J, Boda, Z, Chlumsky, Y, Gibbs, H, Kamphuizen, PW, Monreal, M, Ockleford, P, Pabinger-Fasching, I, Sinnaeve, P, Beenen, L, Gerdes, V, Laleman, W, Larrey, D, van Mechelen, R, Roos, Y, Scheerder, M, Slagboom, T, Thijs, V, Eikelboom, JW, Crowther, M, Roberts, RS, Vanassche, T, Vandenbriele, C, Debaveye, B, Dani, V, Schwocho, L, Duggal, A, Baker, R, Carroll, P, Chan, N, Coughlin, P, Crispin, P, Gallus, A, Hugman, A, Tran, H, Brodmann, M, Mathies, R, Rossmann, D, Deeren, D, Hainaut, P, Jochmans, K, Vercauter, P, Wautrecht, JC, Champion, P, Gross, P, Lee, A, Shivakumar, S, Tagalakis, V, Zed, E, Kovarova, K, Lastuvka, J, Matoska, P, Prosecky, R, Achkar, A, Aquilanti, S, Chatellain, P, Cony-Makhoul, P, Del Piano, F, Elias, A, Falvo, N, Ferrari, E, Mahé, I, Merle, P, Mismetti, P, Muron, T, Pernod, G, Quere, I, Schmidt, J, Stephan, D, Espinola-Klein, C, Horacek, T, Kröning, R, Oettler, W, Schellong, S, Schön, N, Zwemmrich, C, Farkas, K, Gurzo, M, Nyirati, G, Pecsvarady, Z, Riba, M, Becattini, C, Cattaneo, M, Falanga, A, Ghirarduzzi, A, Imberti, D, Lodigiani, C, Parisi, R, Porreca, E, Squizzato, A, Tassoni, MI, Villalta, S, Visonà, A, Beeker, A, Boersma, W, Brouwer, R, Dees, A, Huisman, M, Kuijer, P, Mairuhu, R, Meijer, K, Middeldorp, S, Otten, HM, van Marwijk-Kooy, M, van Wissen, S, Westerweel, P, Harper, P, Merriman, E, Ockelford, P, Royle, G, Smith, M, Cereto Castro, F, de Oña Navarrete, R, Font Puig, C, Gallardo Díaz, E, Garcia-Bragado Dalmau, F, Ruiz Artacho, P, Santamaria, A, Baumann Kreuziger, L, De Sancho, M, Gaddh, M, Metjian, A, Rojas Hernandez, CM, Shah, V, Smith, W, Wun, T, Xiang, Z, Raskob, G, van Es, N, Verhamme, P, Carrier, M, Di Nisio, M, Garcia, D, Grosso, M, Kakkar, A, Kovacs, M, Mercuri, M, Meyer, G, Segers, A, Shi, M, Wang, T, Yeo, E, Zhang, G, Zwicker, J, Weitz, J, Büller, H, Beyer-Westendorf, J, Boda, Z, Chlumsky, Y, Gibbs, H, Kamphuizen, P, Monreal, M, Ockleford, P, Pabinger-Fasching, I, Sinnaeve, P, Beenen, L, Gerdes, V, Laleman, W, Larrey, D, van Mechelen, R, Roos, Y, Scheerder, M, Slagboom, T, Thijs, V, Eikelboom, J, Crowther, M, Roberts, R, Vanassche, T, Vandenbriele, C, Debaveye, B, Dani, V, Schwocho, L, Duggal, A, Baker, R, Carroll, P, Chan, N, Coughlin, P, Crispin, P, Gallus, A, Hugman, A, Tran, H, Brodmann, M, Mathies, R, Rossmann, D, Deeren, D, Hainaut, P, Jochmans, K, Vercauter, P, Wautrecht, J, Champion, P, Gross, P, Lee, A, Shivakumar, S, Tagalakis, V, Zed, E, Kovarova, K, Lastuvka, J, Matoska, P, Prosecky, R, Achkar, A, Aquilanti, S, Chatellain, P, Cony-Makhoul, P, Del Piano, F, Elias, A, Falvo, N, Ferrari, E, Mahé, I, Merle, P, Mismetti, P, Muron, T, Pernod, G, Quere, I, Schmidt, J, Stephan, D, Espinola-Klein, C, Horacek, T, Kröning, R, Oettler, W, Schellong, S, Schön, N, Zwemmrich, C, Farkas, K, Gurzo, M, Nyirati, G, Pecsvarady, Z, Riba, M, Becattini, C, Cattaneo, M, Falanga, A, Ghirarduzzi, A, Imberti, D, Lodigiani, C, Parisi, R, Porreca, E, Squizzato, A, Tassoni, M, Villalta, S, Visonà, A, Beeker, A, Boersma, W, Brouwer, R, Dees, A, Huisman, M, Kuijer, P, Mairuhu, R, Meijer, K, Middeldorp, S, Otten, H, van Marwijk-Kooy, M, van Wissen, S, Westerweel, P, Harper, P, Merriman, E, Ockelford, P, Royle, G, Smith, M, Cereto Castro, F, de Oña Navarrete, R, Font Puig, C, Gallardo Díaz, E, Garcia-Bragado Dalmau, F, Ruiz Artacho, P, Santamaria, A, Baumann Kreuziger, L, De Sancho, M, Gaddh, M, Metjian, A, Rojas Hernandez, C, Shah, V, Smith, W, Wun, T, Xiang, Z, Graduate School, CCA - Cancer Treatment and Quality of Life, Vascular Medicine, ACS - Amsterdam Cardiovascular Sciences, ANS - Neurovascular Disorders, Radiology and Nuclear Medicine, Other Research, Other departments, Neurology, APH - Societal Participation & Health, APH - Quality of Care, Coronel Institute of Occupational Health, ARD - Amsterdam Reproduction and Development, AGEM - Amsterdam Gastroenterology Endocrinology Metabolism, ACS - Atherosclerosis & ischemic syndromes, ACS - Pulmonary hypertension & thrombosis, and ACS - Microcirculation

Subjects
Adult, Dalteparin, Male, Randomization, Pyridines, Hemorrhage, Kaplan-Meier Estimate, 030204 cardiovascular system & hematology, law.invention, 03 medical and health sciences, chemistry.chemical_compound, 0302 clinical medicine, Randomized controlled trial, Recurrence, law, Edoxaban, Neoplasms, medicine, Humans, Aged, Intention-to-treat analysis, Heparin, business.industry, Standard treatment, Low-Molecular-Weight, Anticoagulants, Cancer, Follow-Up Studies, Heparin, Low-Molecular-Weight, Intention to Treat Analysis, Middle Aged, Thiazoles, Venous Thromboembolism, General Medicine, medicine.disease, Thrombosis, chemistry, 030220 oncology & carcinogenesis, Anesthesia, Venous Thromboembolism, cancer, thrombosis, business, medicine.drug
Abstract

BACKGROUND Low-molecular-weight heparin is the standard treatment for cancer-associated venous thromboembolism. The role of treatment with direct oral anticoagulant agents is unclear. METHODS In this open-label, noninferiority trial, we randomly assigned patients with cancer who had acute symptomatic or incidental venous thromboembolism to receive either low-molecular-weight heparin for at least 5 days followed by oral edoxaban at a dose of 60 mg once daily (edoxaban group) or subcutaneous dalteparin at a dose of 200 IU per kilogram of body weight once daily for 1 month followed by dalteparin at a dose of 150 IU per kilogram once daily (dalteparin group). Treatment was given for at least 6 months and up to 12 months. The primary outcome was a composite of recurrent venous thromboembolism or major bleeding during the 12 months after randomization, regardless of treatment duration. RESULTS Of the 1050 patients who underwent randomization, 1046 were included in the modified intention-to-treat analysis. A primary-outcome event occurred in 67 of the 522 patients (12.8%) in the edoxaban group as compared with 71 of the 524 patients (13.5%) in the dalteparin group (hazard ratio, 0.97; 95% confidence interval [CI], 0.70 to 1.36; P = 0.006 for noninferiority; P = 0.87 for superiority). Recurrent venous thromboembolism occurred in 41 patients (7.9%) in the edoxaban group and in 59 patients (11.3%) in the dalteparin group (difference in risk, -3.4 percentage points; 95% CI, -7.0 to 0.2). Major bleeding occurred in 36 patients (6.9%) in the edoxaban group and in 21 patients (4.0%) in the dalteparin group (difference in risk, 2.9 percentage points; 95% CI, 0.1 to 5.6). CONCLUSIONS Oral edoxaban was noninferior to subcutaneous dalteparin with respect to the composite outcome of recurrent venous thromboembolism or major bleeding. The rate of recurrent venous thromboembolism was lower but the rate of major bleeding was higher with edoxaban than with dalteparin. (Funded by Daiichi Sankyo; Hokusai VTE Cancer ClinicalTrials. gov number, NCT02073682.)

Published
2018

7. Extended-Duration Betrixaban Reduces the Risk of Stroke Versus Standard-Dose Enoxaparin Among Hospitalized Medically Ill Patients

Author

Legkonogov, O., Ramacciotti, E., Mikhailova, E., Koryk, V., Adzerikho, I., Schoenerr, H., Mathies, R., Konig, J., Huber, K., Rubinfeld, A., Finfer, S., Manenti, E., Bott, M., Blessing, E., Beyer-Westendorf, J., Coughlin, P., Baker, R., Poy, C., Dengler, T., Parody, M., Oliva, M., Macin, S., Jure, H., Ferrari, A. E., Dziewas, R., Genth-Zotz, S., Hamann, F., Horacek, T., Klimpe, S., Mitkovskaya, N., Kroning, R., Lapp, H., Lawall, H., Licka, M., Rizos, T., Tiefenbacher, C., Weimar, C., Alkonyi, B., Falukozy, J., Futo, L., Katona, A., Berrouschot, J., Kirschner, R., Amann, B., Paposhvili, K., Pagava, Z., Kristof, P., Lakatos, F., Laszlo, Z., Freire, A., Lupkovics, G., Megreladze, I., Kobulia, B., Khintibidze, I., Khabeishvili, G., Datikashvili-David, I., Simoneau, G., Merkely, B., Andras, C. Nagy, Nemeth, L., Papp, A., Soltesz, P., Fiss, E., Schmidt, J., Roy, P-M., Quere, I., Proust, A., Pottier, P., Pernod, G., Payot, L., Bizzacchi, J. Annichino, Lienart, F., Paleiron, N., Montaclair, K., Mismetti, P., Messas, E., Lacroix, P., Grange, C., Falvo, N., El Kouri, D., Decoulx, E., Debourdeau, P., De Geeter, G., Brisot, D., Belhassane, A., Aquilanti, S., Agraou, B., Vikman, S., Tatlisumak, T., Saarinen, J., Kaaja, R., Honkaniemi, J., Airaksinen, J., Uuetoa, T., Lember, M., Urhammer, S., Tuxen, C., Storgaard, M., Lassen, M., Christensen, H., Vyhnanek, M., Vejvoda, J., Spacek, R., Reiterer, P., Podpera, I., Mikulova, J., Lang, P., Jajtner, P., Hubac, J., Horny, I., Holaj, R., Herold, M., Havelka, J., Francek, L., Dusek, J., Dunaj, M., Cizek, V., Chochola, J., Chlumsky, J., Cermak, O., Skerk, V., Vagic, J. Sikic, Marusic, S., Knezevic, A., Kalinic-Grgorinic, H., Jakopovic, M., Francetic, I., Ciglenecki, N., Car, S., Butkovic-Soldo, S., Cardenas, S. Potthoff, Lazcano, M. Opazo, Alarcon, M. Arias, Verreault, S., Provencher, S., Pearce, M., Le Gal, G., Douketis, J., Dhar, A., Tokmakova, M., Todorov, G., Syulemzova, S., Raymuno, S., Rocha, A., Dimov, B., Grigorov, M., Kalpachki, R., Kamenova, Z., Bello, F., Harrington, Robert A., Bandman, Olga, Kostadinova, M., Milanova, M., Dive, A., Pencheva, G., Sudar, Z., Szabo, G., Szegedi, N., Timar, G., Valco, J., Delforge, M., Vertes, A., Efrati, S., Elias, M., Gafter, A., Nazliel, BİJEN, Hayek, T., Hussein, O., Lishner, M., Lugassy, G., Cerveri, I., D'Angelo, A., De Pellegrin, A., Imberti, D., Landolfi, R., Runev, N., Lembo, G., Lodigiani, C., Moia, M., Molteni, M., Mumoli, N., Novo, S., Orlandini, F., Stoeva, N., Parisi, R., Pizzini, A., Pomero, F., Salvi, A., Schenone, A., Gold, Alex, Visona, A., Martinova, V., Pontaga, N., Rozitis, V., Stukena, I., Alekniene, B., Basijokiene, V., Butkiene, Z., Griskeviciene, V., Naudziunas, A., Stoyanov, M., Norvaisiene, R., Norviliene, R., Petrauskiene, R., Poskiene, R., Susinskiene, D., Valavicius, A., Castillo Leon, R., Pimanov, S., Polonetsy, L., Pereyra, R. Cotrina, Karlo, L. Farjardo, Horna, M., Soroka, N., Salas, M., Yanez, L. Toche, Fryze, W., Gaciong, Z., Gniot, J., Gorecka, D., Gruenpeter, P., Grzelakowski, P., Jastrzebski, D., Kucharski, L., Mirek-Bryniarska, E., Pulkowski, G., Sobkowicz, B., Sulik, P., Walasek, L., Blockmans, D., Waldemar, K., Wrzesinski, K., Balogh, Z. E., Bojinca, M., Marin, I., Musetescu, R., Podoleanu, C., Popescu, M., Stamate, S., Stanciulescu, G., Vida-Simiti, L., Abashev, A., Andreev, D., Apartsin, K., Arkhipov, M., Averkov, O., Barbarash, O., Belskaya, G., Bogdanov, E., Boldueva, S., Chefranova, Z., Dovgalevskiy, Y., Ershova, O., Goloshchekin, B., Khachatryan, N., Klein, G., Kobalava, Z., Kosmacheva, E., Kostenko, V., Malygin, A., Martynenko, T., Martynenko, V., Maslova, N., Mordovin, V., Nikolaev, K., Nilk, R., Popov, D., Privalova, E., Reshetko, O., Shapovalova, Y., Shpagina, L., Shvarts, Y., Simanenkov, V., Solovyov, O., Vishneva, E., Vishnevskiy, A., Apostolovic, S., Celic, V., Ilic, S., Kovacevic-Kuzmanovic, A., Miloradovic, V., Bodikova, S., Cervenakova, A., Dvorak, M., Herman, O., Hrubon, A., Kokles, M., Krastev, G., Payer, J., Prokop, D., Spisakova, M., Adler, D., Basson, M., Breedt, J., Engelbrecht, J., Mitha, I., Van Dyk, C., Alvarez Sala, L. A., Barbagelata Lopez, C., Bisbe, J., Castro Guardiola, A., Cepeda, J. M., Cereto, F., Diaz Santos, E., Ferrer, R., Gomez Cerezo, J., Hernandez, Adrian F., Gonzales-Porras, J. R., Grandes, J., Cohen, Alexander T., Gibson, C. Michael, Chi, Gerald, Halaby, Rim, Korjian, Serge, Daaboul, Yazan, Jain, Purva, Arbetter, Douglas, Goldhaber, Samuel Z., Hull, Russel, Jimenez, D., Mellibovsky, L., Richart, C., Riera, A., Trujillo, J., Vargas Nunez, J. A., Villalta, J., Akgul, O., Guneri, S., Kilichesmez, K., Kirma, C., Kutluk, H., Okumus, G., Tigen, K., Topcuoglu, M., Tuncay, E., Abrahamovych, O., Batushkin, V., Brozhyk, J., Burmak, I., Godlevska, O., Goloborodko, A., Goloborodko, B., Goncharova, Y., Gryb, V., Karpenko, O., Kopytsya, M., Zakai, N., Yousef, K., Wichman, T., Whitman, B., Welker, J., Welch, M., Warner, A., Updegrove, J., Tuck, M., Stoltz, S., Sokol, S., Sharma, S., Shammas, N., Saba, F., Rodriguez, W., Rees, C., Rastogi, P., Rajan, R., Quintana, O., Pullman, J., Pratt, R., Pineda, L., Pearl, R., Parthiban, K., Overcash, J., Ortel, T., Ohaju, V., Nadar, V., Mittal, M., Milling, T., McLaren, G., Margolis, B., Mahal, S., Macchiavelli, A., Lopez, J., Lerner, R., Kung, M., Kouras, F., Kazimir, M., Kao, C-K., Kabler, H., Ioachimescu, O., Hazelrigg, M., Hamad, A., Haidar, A., Hahn, B., Goytia-Leos, D., Gaggin, H., Fulmer, J., Koshlia, V., Fraiz, J., Krakhmalova, O., Fermann, G., Farley, B., Doshi, A., Dhingra, R., Cornell, J., Concha, M., Clark, C., Chang, H., Carman, T., Bidair, M., Bercz, P., Bastani, A., Barney, J., Baker, S., Anderson, C., Amin, M., Almasri, E., Natarajan, I., McCollum, C., MacCallum, P., Davis, M., Body, R., Yagensky, A., Voronkov, L., Vishnivestsky, I., Vakaliuk, I., Ursol, G., Tseluyko, V., Kyrychenko, I., Svyshchenko, Y., Svyridova, I., Ryabichenko, T., Rudenko, L., Reshotko, D., Perepeliuk, M., Parkhomenko, O., Nikonov, V., Maslovaskyi, V., Malynovsky, Y., Sergeeva, E., and Kolman, P.

Subjects
Male, medicine.medical_specialty, Pyridines, Intracranial Hemorrhages, 030204 cardiovascular system & hematology, 03 medical and health sciences, chemistry.chemical_compound, 0302 clinical medicine, Medical illness, Physiology (medical), medicine, Humans, 030212 general & internal medicine, Enoxaparin, Intensive care medicine, Stroke, Aged, business.industry, Anticoagulants, Venous Thromboembolism, medicine.disease, Thrombosis, chemistry, Betrixaban, Benzamides, Emergency medicine, Female, Cardiology and Cardiovascular Medicine, business, Complication, Venous thromboembolism
Abstract

Background: Stroke is a morbid and potentially mortal complication among patients hospitalized with acute medical illness. The potential of extended-duration thromboprophylaxis with the factor Xa inhibitor betrixaban to reduce the risk of stroke compared with standard-dose enoxaparin in this population was assessed in this retrospective APEX trial substudy (Acute Medically Ill Venous Thromboembolism Prevention With Extended Duration Betrixaban). Methods: Hospitalized acutely medically ill subjects (n=7513) were randomized in a double-dummy double-blind fashion to either extended-duration oral betrixaban (80 mg once daily for 35–42 days) or standard-dose subcutaneous enoxaparin (40 mg once daily for 10±4 days) for venous thromboprophylaxis. Stroke events were adjudicated by an independent, blinded event adjudication committee. Results: The mean age of study participants was 76 years; 45% were male; 13% had had a stroke; and 45% had congestive heart failure. There were fewer all-cause strokes (0.54% versus 0.97%; relative risk [RR]=0.56; 95% confidence interval, 0.32–0.96; P =0.032; adjusted RR=0.43%; number needed to treat=233) and ischemic strokes (0.48% versus 0.91%; RR=0.53; 95% confidence interval, 0.30–0.94; P =0.026; adjusted RR=0.43%; number needed to treat=233) among patients treated with betrixaban versus enoxaparin through 77 days of follow-up. Among high-risk subjects, those with congestive heart failure or ischemic stroke as their index event, betrixaban reduced the risk of all-cause stroke (0.72% versus 1.48%; RR=0.49; 95% confidence interval, 0.26–0.90; P =0.019; adjusted RR=0.76%; number needed to treat=132) and ischemic stroke (0.63% versus 1.38%; RR=0.45; 95% confidence interval, 0.24–0.87; P =0.014; adjusted RR=0.75%; number needed to treat=134) compared with enoxaparin. Conclusions: Among hospitalized medically ill patients, extended-duration betrixaban significantly reduced all-cause stroke and ischemic stroke through 77 days of follow-up Clinical Trial Registration: URL: http://www.clinicaltrials.gov . Unique identifier: NCT01583218.

Published
2017

8. Long-term safety and efficacy of subcutaneous immunoglobulin IgPro20 in CIDP: PATH extension study

Author

van Schaik, Ivo N, Mielke, Orell, Bril, Vera, van Geloven, Nan, Hartung, Hans-Peter, Lewis, Richard A, Sobue, Gen, Lawo, John-Philip, Praus, Michaela, Durn, Billie L, Cornblath, David R, Merkies, Ingemar SJ, Sabet, A, George, K, Roberts, L, Carne, R, Blum, S, Henderson, R, Van Damme, P, Demeestere, J, Larue, S, D'Amour, C, Bril, V, Breiner, A, Kunc, P, Michal, V, Sussova, J, Tomas, K, Talab, R, Michal, B, Toomsoo, T, Rubanovits, I, Gross-Paju, K, Sorro, U, Saarela, M, Auranen, M, Pouget, J, Attarian, S, Le Masson, G, Wielanek-Bachelet, A, Desnuelle, C, Delmont, E, Clavelou, P, Aufauvre, D, Schmidt, J, Zschumtszsch, J, Sommer, C, Kramer, D, Hoffmann, O, Goerlitz, C, Haas, J, Chatzopoulos, M, Yoon, R, Gold, R, Berlit, P, Jaspert-Grehl, A, Liebetanz, D, Kutschenko, A, Stangel, M, Trebst, C, Baum, P, Bergh, F, Klehmet, J, Meisel, A, Klostermann, F, Oechtering, J, Lehmann, H, Schroeter, M, Hagenacker, T, Mueller, D, Sperfeld, A, Bethke, F, Drory, V, Algom, A, Yarnitsky, D, Murinson, B, Di Muzio, A, Ciccocioppo, F, Sorbi, S, Mata, S, Schenone, A, Grandis, M, Lauria, G, Cazzato, D, Antonini, G, Morino, S, Cocito, D, Zibetti, M, Yokota, T, Ohkubo, T, Kanda, T, Kawai, M, Kaida, K, Onoue, H, Kuwabara, S, Mori, M, Iijima, M, Ohyama, K, Baba, M, Tomiyama, M, Nishiyama, K, Akutsu, T, Yokoyama, K, Kanai, K, van Schaik, IN, Eftimov, F, Notermans, NC, Visser, N, Faber, C, Hoeijmakers, J, Rejdak, K, Chyrchel-Paszkiewicz, U, Casanovas Pons, C, Antonia, M, Gamez, J, Salvado, M, Marquez Infante, C, Benitez, S, Lunn, M, Morrow, J, Gosal, D, Lavin, T, Melamed, I, Testori, A, Ajroud-Driss, S, Menichella, D, Simpson, E, Lai, E Chi-Ho, Dimachkie, M, Barohn, RJ, Beydoun, S, Johl, H, Lange, D, Shtilbans, A, Muley, S, Ladha, S, Freimer, M, Kissel, J, Latov, N, Chin, R, Ubogu, E, Mumfrey, S, Rao, T, MacDonald, P, Sharma, K, Gonzalez, G, Allen, J, Walk, D, Hobson-Webb, L, Gable, K, Klinische Neurowetenschappen, MUMC+: MA Med Staf Spec Neurologie (9), RS: MHeNs - R1 - Cognitive Neuropsychiatry and Clinical Neuroscience, Hagenacker, Tim (Beitragende*r), HUS Neurocenter, Neurologian yksikkö, Clinicum, Department of Neurosciences, Academic Medical Center, and CSL Behring

Subjects
Adult, Male, medicine.medical_specialty, Time Factors, Injections, Subcutaneous, Medizin, Chronic inflammatory demyelinating polyneuropathy, Subcutaneous immunoglobulin, INFLAMMATORY DEMYELINATING POLYNEUROPATHY, Gastroenterology, 3124 Neurology and psychiatry, law.invention, 03 medical and health sciences, MUSCLE STRENGTH, 0302 clinical medicine, Randomized controlled trial, law, Internal medicine, Humans, Medicine, Prospective Studies, Dosing, Adverse effect, Prospective cohort study, Aged, 030304 developmental biology, 0303 health sciences, MMN, business.industry, Extension study, 3112 Neurosciences, Immunoglobulins, Intravenous, Polyradiculoneuropathy, Middle Aged, medicine.disease, 3. Good health, Treatment Outcome, Polyradiculoneuropathy, Chronic Inflammatory Demyelinating, Neurology, Immunoglobulin G, Female, Neurology (clinical), business, 030217 neurology & neurosurgery, Follow-Up Studies
Abstract

PATH study group., [Objective] To investigate the long-term safety and efficacy of weekly subcutaneous IgPro20 (Hizentra, CSL Behring) in chronic inflammatory demyelinating polyneuropathy (CIDP)., [Methods] In a 48-week open-label prospective extension study to the PATH study, patients were initially started on 0.2 g/kg or on 0.4 g/kg weekly and—if clinically stable—switched to 0.2 g/kg weekly after 24 weeks. Upon CIDP relapse on the 0.2 g/kg dose, 0.4 g/kg was (re)initiated. CIDP relapse was defined as a deterioration by at least 1 point in the total adjusted Inflammatory Neuropathy Cause and Treatment score., [Results] Eighty-two patients were enrolled. Sixty-two patients initially received 0.4 g/kg, 20 patients 0.2 g/kg weekly. Seventy-two received both doses during the study. Sixty-six patients (81%) completed the 48-week study duration. Overall relapse rates were 10% in 0.4 g/kg–treated patients and 48% in 0.2 g/kg–treated patients. After dose reduction from 0.4 to 0.2 g/kg, 51% (27/53) of patients relapsed, of whom 92% (24 of 26) improved after reinitiation of the 0.4 g/kg dose. Two-thirds of patients (19/28) who completed the PATH study without relapse remained relapse-free on the 0.2 g/kg dose after dose reduction in the extension study. Sixty-two patients had adverse events (AEs) (76%), of which most were mild or moderate with no related serious AEs., [Conclusions] Subcutaneous treatment with IgPro20 provided long-term benefit at both 0.4 and 0.2 g/kg weekly doses with lower relapse rates on the higher dose. Long-term dosing should be individualized to find the most appropriate dose in a given patient. Classification of evidence This study provides Class IV evidence that for patients with CIDP, long-term treatment with SCIG beyond 24 weeks is safe and efficacious., This study was supported by CSL Behring.

Published
2019

9. Monitoring Inflammation (Including Fever) in Acute Brain Injury

Author

Provencio J. J., Badjatia N., Le Roux P., Menon D. K., Vespa P., Citerio G., Bader M. K., Brophy G. M., Diringer M. N., Stocchetti N., Videtta W., Armonda R., Boesel J., Chesnut R., Chou S., Claassen J., Czosnyka M., De Georgia M., Figaji A., Fugate J., Helbok R., Horowitz D., Hutchinson P., Kumar M., McNett M., Miller C., Naidech A., Oddo M., Olson D., O'Phelan K., Puppo C., Riker R., Robertson C., Schmidt J. M., Taccone F., Provencio, J, Badjatia, N, Le Roux, P, Menon, D, Vespa, P, Citerio, G, Bader, M, Brophy, G, Diringer, M, Stocchetti, N, Videtta, W, Armonda, R, Boesel, J, Chesnut, R, Chou, S, Claassen, J, Czosnyka, M, De Georgia, M, Figaji, A, Fugate, J, Helbok, R, Horowitz, D, Hutchinson, P, Kumar, M, Mcnett, M, Miller, C, Naidech, A, Oddo, M, Olson, D, O'Phelan, K, Puppo, C, Riker, R, Robertson, C, Schmidt, J, and Taccone, F

Subjects
medicine.medical_specialty, Neurology, Critical Care, Fever, Monitoring, medicine.medical_treatment, Inflammation, Targeted temperature management, Critical Care and Intensive Care Medicine, C-reactive protein, Predictive Value of Tests, White blood cell, Neurocritical care, medicine, Humans, Brain injury, Intensive care medicine, Immunity, Cellular, biology, business.industry, Shivering, Neurointensive care, Prognosis, medicine.anatomical_structure, Brain Injuries, Inflammatory cascade, biology.protein, Neurology (clinical), Inflammation Mediators, medicine.symptom, business, Biomarkers
Abstract

Inflammation is an important part of the normal physiologic response to acute brain injury (ABI). How inflammation is manifest determines if it augments or hinders the resolution of ABI. Monitoring body temperature, the cellular arm of the inflammatory cascade, and inflammatory proteins may help guide therapy. This summary will address the utility of inflammation monitoring in brain-injured adults. An electronic literature search was conducted for English language articles describing the testing, utility, and optimal methods to measure inflammation in ABI. Ninety-four articles were included in this review. Current evidence suggests that control of inflammation after ABI may hold promise for advances in good outcomes. However, our understanding of how much inflammation is good and how much is deleterious is not yet clear. Several important concepts emerge form our review. First, while continuous temperature monitoring of core body temperature is recommended, temperature pattern alone is not useful in distinguishing infectious from noninfectious fever. Second, when targeted temperature management is used, shivering should be monitored at least hourly. Finally, white blood cell levels and protein markers of inflammation may have a limited role in distinguishing infectious from noninfectious fever. Our understanding of optimal use of inflammation monitoring after ABI is limited currently but is an area of active investigation.

Published
2014

10. Intracranial Pressure and Cerebral Perfusion Pressure Monitoring in Non-TBI Patients: Special Considerations

Author

Helbok R., Olson D. W. M., Le Roux P. D., Vespa P., Menon D. K., Citerio G., Bader M. K., Brophy G. M., Diringer M. N., Stocchetti N., Videtta W., Armonda R., Badjatia N., Boesel J., Chesnut R., Chou S., Claassen J., Czosnyka M., De Georgia M., Figaji A., Fugate J., Horowitz D., Hutchinson P., Kumar M., McNett M., Miller C., Naidech A., Oddo M., O'Phelan K., Provencio J., Puppo C., Riker R., Robertson C., Schmidt J. M., Taccone F., Helbok, R, Olson, D, Le Roux, P, Vespa, P, Menon, D, Citerio, G, Bader, M, Brophy, G, Diringer, M, Stocchetti, N, Videtta, W, Armonda, R, Badjatia, N, Boesel, J, Chesnut, R, Chou, S, Claassen, J, Czosnyka, M, De Georgia, M, Figaji, A, Fugate, J, Horowitz, D, Hutchinson, P, Kumar, M, Mcnett, M, Miller, C, Naidech, A, Oddo, M, O'Phelan, K, Provencio, J, Puppo, C, Riker, R, Robertson, C, Schmidt, J, and Taccone, F

Subjects
Ventriculostomy, medicine.medical_specialty, Neurology, Subarachnoid hemorrhage, Critical Care, Intracranial Pressure, Traumatic brain injury, medicine.medical_treatment, Critical Care and Intensive Care Medicine, medicine, Humans, Cerebral perfusion pressure, Intracranial pressure, Coma, Intracerebral hemorrhage, Brain Diseases, integumentary system, business.industry, Patient Selection, musculoskeletal, neural, and ocular physiology, Prognosis, medicine.disease, Neurophysiological Monitoring, humanities, nervous system diseases, Brain edema, Coma, CPP, ICP, Intracerebral hemorrhage, Subarachnoid hemorrhage, Ventriculostomy, Cerebrovascular Circulation, Anesthesia, Neurology (clinical), medicine.symptom, business
Abstract

The effect of intracranial pressure (ICP) and the role of ICP monitoring are best studied in traumatic brain injury (TBI). However, a variety of acute neurologic illnesses e.g., subarachnoid hemorrhage, intracerebral hemorrhage, ischemic stroke, meningitis/encephalitis, and select metabolic disorders, e.g., liver failure and malignant, brain tumors can affect ICP. The purpose of this paper is to review the literature about ICP monitoring in conditions other than TBI and to provide recommendations how the technique may be used in patient management. A PubMed search between 1980 and September 2013 identified 989 articles; 225 of which were reviewed in detail. The technique used to monitor ICP in non-TBI conditions is similar to that used in TBI; however, indications for ICP monitoring often are intertwined with the presence of obstructive hydrocephalus and hence the use of ventricular catheters is more frequent. Increased ICP can adversely affect outcome, particularly when it fails to respond to treatment. However, patients with elevated ICP can still have favorable outcomes. Although the influence of ICP-based care on outcome in non-TBI conditions appears less robust than in TBI, monitoring ICP and cerebral perfusion pressure can play a role in guiding therapy in select patients.

Published
2014

11. International Multidisciplinary Consensus Conference on Multimodality Monitoring: ICU Processes of Care

Author

McNett M. M., Horowitz D. A., Le Roux P., Menon D. K., Vespa P., Citerio G., Bader M. K., Brophy G. M., Diringer M. N., Stocchetti N., Videtta W., Armonda R., Badjatia N., Boesel J., Chesnut R., Chou S., Claassen J., Czosnyka M., De Georgia M., Figaji A., Fugate J., Helbok R., Hutchinson P., Kumar M., Miller C., Naidech A., Oddo M., Olson D., O'Phelan K., Provencio J., Puppo C., Riker R., Robertson C., Schmidt J. M., Taccone F., Mcnett, M, Horowitz, D, Le Roux, P, Menon, D, Vespa, P, Citerio, G, Bader, M, Brophy, G, Diringer, M, Stocchetti, N, Videtta, W, Armonda, R, Badjatia, N, Boesel, J, Chesnut, R, Chou, S, Claassen, J, Czosnyka, M, De Georgia, M, Figaji, A, Fugate, J, Helbok, R, Hutchinson, P, Kumar, M, Miller, C, Naidech, A, Oddo, M, Olson, D, O'Phelan, K, Provencio, J, Puppo, C, Riker, R, Robertson, C, Schmidt, J, and Taccone, F

Subjects
medicine.medical_specialty, Consensus, Internationality, Critical Care, Population, MEDLINE, Benchmark, Critical Care and Intensive Care Medicine, law.invention, Clinical Protocols, Ambulatory care, law, Intensive care, Critical care nursing, Health care, Neurocritical care, Humans, Medicine, Mortality, Intensive care medicine, education, Outcome, education.field_of_study, business.industry, Process Assessment, Health Care, Neurointensive care, medicine.disease, Quality, Neurophysiological Monitoring, Intensive care unit, Brain Injuries, Neurology (clinical), Medical emergency, business
Abstract

There is an increased focus on evaluating processes of care, particularly in the high acuity and cost environment of intensive care. Evaluation of neurocritical-specific care and evidence-based protocol implementation are needed to effectively determine optimal processes of care and effect on patient outcomes. General quality measures to evaluate intensive care unit (ICU) processes of care have been proposed; however, applicability of these measures in neurocritical care populations has not been established. A comprehensive literature search was conducted for English language articles from 1990 to August 2013. A total of 1,061 articles were reviewed, with 145 meeting criteria for inclusion in this review. Care in specialized neurocritical care units or by neurocritical teams can have a positive impact on mortality, length of stay, and in some cases, functional outcome. Similarly, implementation of evidence-based protocol-directed care can enhance outcome in the neurocritical care population. There is significant evidence to support suggested quality indicators for the general ICU population, but limited research regarding specific use in neurocritical care. Quality indices for neurocritical care have been proposed; however, additional research is needed to further validate measures.

Published
2014

12. Monitoring Nutrition and Glucose in Acute Brain Injury

Author

Badjatia N., Vespa P., Le Roux P., Menon D. K., Citerio G., Bader M. K., Brophy G. M., Diringer M. N., Stocchetti N., Videtta W., Armonda R., Boesel J., Chesnut R., Chou S., Claassen J., Czosnyka M., De Georgia M., Figaji A., Fugate J., Helbok R., Horowitz D., Hutchinson P., Kumar M., McNett M., Miller C., Naidech A., Oddo M., Olson D., O'Phelan K., Provencio J., Puppo C., Riker R., Robertson C., Schmidt J. M., Taccone F., Badjatia, N, Vespa, P, Le Roux, P, Menon, D, Citerio, G, Bader, M, Brophy, G, Diringer, M, Stocchetti, N, Videtta, W, Armonda, R, Boesel, J, Chesnut, R, Chou, S, Claassen, J, Czosnyka, M, De Georgia, M, Figaji, A, Fugate, J, Helbok, R, Horowitz, D, Hutchinson, P, Kumar, M, Mcnett, M, Miller, C, Naidech, A, Oddo, M, Olson, D, O'Phelan, K, Provencio, J, Puppo, C, Riker, R, Robertson, C, Schmidt, J, and Taccone, F

Subjects
Blood Glucose, medicine.medical_specialty, Neurology, Critical Care, Population, Critical Care and Intensive Care Medicine, Enteral Nutrition, medicine, Humans, education, Adverse effect, Intensive care medicine, Neurophysiological Monitoring, Blood glucose monitoring, education.field_of_study, medicine.diagnostic_test, business.industry, Neurointensive care, Calorimetry, Indirect, Anthropometry, Nutrition Assessment, Parenteral nutrition, Brain Injuries, Neurology (clinical), Energy Metabolism, Brain injury, Energy expenditure, Glucose, Monitoring, Nitrogen balance, Nutritional assessment, business
Abstract

The metabolic response to injury is well described; however, very little is understood about optimal markers to measure this response. This summary will address the current evidence about monitoring nutritional status including blood glucose after acute brain injury (ABI). An electronic literature search was conducted for English language articles describing the testing, utility, and optimal methods to measure nutritional status and blood glucose levels in the neurocritical care population. A total of 45 articles were included in this review. Providing adequate and timely nutritional support can help improve outcome after ABI. However, the optimal content and total nutrition requirements remain unclear. In addition, how best to monitor the nutritional status in ABI is still being elucidated, and at present, there is no validated optimal method to monitor the global response to nutritional support on a day-to-day basis in ABI patients. Nitrogen balance may be monitored to assess the adequacy of caloric intake as it relates to protein energy metabolism, but indirect calorimetry, anthropometric measurement, or serum biomarker requires further validation. The adverse effects of hyperglycemia in ABI are well described, and data indicate that blood glucose should be carefully controlled in critically ill patients. However, the optimal frequency or duration for blood glucose monitoring after ABI remains poorly defined. There are significant knowledge gaps about monitoring nutritional status and response to nutritional interventions in ABI; these need to be addressed and hence few recommendations can be made. The optimal frequency and duration of blood glucose monitoring need further study.

Published
2014

13. Multimodality Monitoring: Informatics, Integration Data Display and Analysis

Author

Schmidt J. M., De Georgia M., Le Roux P., Menon D. K., Vespa P., Citerio G., Bader M. K., Brophy G. M., Diringer M. N., Stocchetti N., Videtta W., Armonda R., Badjatia N., Boesel J., Chesnut R., Chou S., Claassen J., Czosnyka M., Figaji A., Fugate J., Helbok R., Horowitz D., Hutchinson P., Kumar M., McNett M., Miller C., Naidech A., Oddo M., Olson D., O'Phelan K., Provencio J., Puppo C., Riker R., Robertson C., Taccone F., Schmidt, J, De Georgia, M, Le Roux, P, Menon, D, Vespa, P, Citerio, G, Bader, M, Brophy, G, Diringer, M, Stocchetti, N, Videtta, W, Armonda, R, Badjatia, N, Boesel, J, Chesnut, R, Chou, S, Claassen, J, Czosnyka, M, Figaji, A, Fugate, J, Helbok, R, Horowitz, D, Hutchinson, P, Kumar, M, Mcnett, M, Miller, C, Naidech, A, Oddo, M, Olson, D, O'Phelan, K, Provencio, J, Puppo, C, Riker, R, Robertson, C, and Taccone, F

Subjects
Information management, Telemedicine, Decision support system, Critical Care, business.industry, Critical care, Data display, Data integration, Decision support, Informatics, Neuromonitoring, Critical Care and Intensive Care Medicine, computer.software_genre, Neurophysiological Monitoring, Health informatics, Data science, Data warehouse, Systems Integration, Intensive care, Informatics, Data Display, Humans, Medicine, Medical Informatics Applications, Neurology (clinical), business, computer, Data integration
Abstract

The goal of multimodality neuromonitoring is to provide continuous, real-time assessment of brain physiology to prevent, detect, and attenuate secondary brain injury. Clinical informatics deals with biomedical data, information, and knowledge including their acquisition, storage, retrieval, and optimal use for clinical decision-making. An electronic literature search was conducted for English language articles describing the use of informatics in the intensive care unit setting from January 1990 to August 2013. A total of 64 studies were included in this review. Clinical informatics infrastructure should be adopted that enables a wide range of linear and nonlinear analytical methods be applied to patient data. Specific time epochs of clinical interest should be reviewable. Analysis strategies of monitor alarms may help address alarm fatigue. Ergonomic data display that present results from analyses with clinical information in a sensible uncomplicated manner improve clinical decision-making. Collecting and archiving the highest resolution physiologic and phenotypic data in a comprehensive open format data warehouse is a crucial first step toward information management and two-way translational research for multimodality monitoring. The infrastructure required is largely the same as that needed for telemedicine intensive care applications, which under the right circumstances improves care quality while reducing cost.

Published
2014

14. Changes in health in the countries of the UK and 150 English Local Authority areas 1990-2016: a systematic analysis for the Global Burden of Disease Study 2016

Author

Steel, N, Ford, JA, Newton, JN, Davis, ACJ, Vos, T, Naghavi, M, Glenn, S, Hughes, A, Dalton, AM, Stockton, D, Humphreys, C, Dallat, M, Schmidt, J, Flowers, J, Fox, S, Abubakar, I, Aldridge, RW, Baker, A, Brayne, C, Brugha, T, Capewell, S, Car, J, Cooper, C, Ezzati, M, Fitzpatrick, J, Greaves, F, Hay, R, Hay, S, Kee, F, Larson, HJ, Lyons, RA, Majeed, A, McKee, M, Rawaf, S, Rutter, H, Saxena, S, Sheikh, A, Smeeth, L, Viner, RM, Vollset, SE, Williams, HC, Wolfe, C, Woolf, A, Murray, CJL, Brayne, Carol [0000-0001-5307-663X], and Apollo - University of Cambridge Repository

Subjects
Adult, Male, Adolescent, Health Status, Article, Global Burden of Disease, Disability Evaluation, Young Adult, Life Expectancy, SDG 3 - Good Health and Well-being, Risk Factors, General & Internal Medicine, Cause of Death, Poverty Areas, Humans, Disabled Persons, Mortality, Child, Aged, Medicine(all), Aged, 80 and over, Infant, Newborn, Infant, 11 Medical And Health Sciences, Health Status Disparities, Middle Aged, United Kingdom, Socioeconomic Factors, Child, Preschool, Female, Quality-Adjusted Life Years
Abstract

Background: Previous studies have reported national and regional Global Burden of Disease (GBD) estimates for the UK. Because of substantial variation in health within the UK, action to improve it requires comparable estimates of disease burden and risks at country and local levels. The slowdown in the rate of improvement in life expectancy requires further investigation. We use GBD 2016 data on mortality, causes of death, and disability to analyse the burden of disease in the countries of the UK and within local authorities in England by deprivation quintile. Methods: We extracted data from the GBD 2016 to estimate years of life lost (YLLs), years lived with disability (YLDs), disability-adjusted life-years (DALYs), and attributable risks from 1990 to 2016 for England, Scotland, Wales, Northern Ireland, the UK, and 150 English Upper-Tier Local Authorities. We estimated the burden of disease by cause of death, condition, year, and sex. We analysed the association between burden of disease and socioeconomic deprivation using the Index of Multiple Deprivation. We present results for all 264 GBD causes of death combined and the leading 20 specific causes, and all 84 GBD risks or risk clusters combined and 17 specific risks or risk clusters. Findings: The leading causes of age-adjusted YLLs in all UK countries in 2016 were ischaemic heart disease, lung cancers, cerebrovascular disease, and chronic obstructive pulmonary disease. Age-standardised rates of YLLs for all causes varied by two times between local areas in England according to levels of socioeconomic deprivation (from 14 274 per 100 000 population [95% uncertainty interval 12 791–15 875] in Blackpool to 6888 [6145–7739] in Wokingham). Some Upper-Tier Local Authorities, particularly those in London, did better than expected for their level of deprivation. Allowing for differences in age structure, more deprived Upper-Tier Local Authorities had higher attributable YLLs for most major risk factors in the GBD. The population attributable fractions for all-cause YLLs for individual major risk factors varied across Upper-Tier Local Authorities. Life expectancy and YLLs have improved more slowly since 2010 in all UK countries compared with 1990–2010. In nine of 150 Upper-Tier Local Authorities, YLLs increased after 2010. For attributable YLLs, the rate of improvement slowed most substantially for cardiovascular disease and breast, colorectal, and lung cancers, and showed little change for Alzheimer's disease and other dementias. Morbidity makes an increasing contribution to overall burden in the UK compared with mortality. The age-standardised UK DALY rate for low back and neck pain (1795 [1258–2356]) was higher than for ischaemic heart disease (1200 [1155–1246]) or lung cancer (660 [642–679]). The leading causes of ill health (measured through YLDs) in the UK in 2016 were low back and neck pain, skin and subcutaneous diseases, migraine, depressive disorders, and sense organ disease. Age-standardised YLD rates varied much less than equivalent YLL rates across the UK, which reflects the relative scarcity of local data on causes of ill health. Interpretation: These estimates at local, regional, and national level will allow policy makers to match resources and priorities to levels of burden and risk factors. Improvement in YLLs and life expectancy slowed notably after 2010, particularly in cardiovascular disease and cancer, and targeted actions are needed if the rate of improvement is to recover. A targeted policy response is also required to address the increasing proportion of burden due to morbidity, such as musculoskeletal problems and depression. Improving the quality and completeness of available data on these causes is an essential component of this response. Funding: Bill & Melinda Gates Foundation and Public Health England.

Published
2018

15. Comparison of Fatal or Irreversible Events With Extended-Duration Betrixaban Versus Standard Dose Enoxaparin in Acutely III Medical Patients: An APEX Trial Substudy

Author

Gibson, C. M., Korjian, S., Chi, G., Daaboul, Y., Jain, P., Arbetter, D., Goldhaber, S. Z., Hull, R., Hernandez, A. F., Lopes, R. D., Gold, A., Cohen, A. T., Harrington, R. A., Bello, F., Ferrari, A. E., Jure, H., Macin, S., Oliva, M., Parody, M., Poy, C., Baker, R., Colquhoun, D., Coughlin, P., Finfer, S., Hammerschlag, G., Rubinfeld, A., Huber, K., Konig, J., Mathies, R., Pilger, E., Schoenerr, H., Adzerikho, I., Koryk, V., Mikhailova, E., Mitkovskaya, N., Pimanov, S., Polonetsy, L., Soroka, N., Blockmans, D., Delforge, M., Dive, A., Lienart, F., Motte, S., Annichino Bizzacchi, J., Fiss, E., Freire, A., Manenti, E., Ramacciotti, E., Raymuno, S., Rocha, A., Saraiva, J. F., Dimov, B., Grigorov, M., Kalpachki, R., Kamenova, Z., Kostadinova, M., Milanova, M., Mincheva, V., Pencheva, G., Raev, D., Runev, N., Stoeva, N., Stoyanov, M., Syulemzova, S., Todorov, G., Tokmakova, M., Dhar, A., Douketis, J., Kahn, S., Le Gal, G., Pearce, M., Provencher, S., Verreault, S., Arias Alarcon, M., Olivares Canon, C., Opazo Lazcano, M., Potthoff Cardenas, S., Butkovic-Soldo, S., Car, S., Ciglenecki, N., Francetic, I., Jakopovic, M., Kalinic-Grgorinic, H., Knezevic, A., Malojcic, B., Marusic, S., Sikic Vagic, J., Skerk, V., Cermak, O., Cervinka, P., Chlumsky, J., Chochola, J., Cizek, V., Dunaj, M., Dusek, J., Francek, L., Havelka, J., Herold, M., Holaj, R., Horny, I., Hubac, J., Jajtner, P., Kolman, P., Lang, P., Mayer, O., Mikulova, J., Podpera, I., Reiterer, P., Spacek, R., Vejvoda, J., Vyhnanek, M., Christensen, H., Lassen, M., Storgaard, M., Tuxen, C., Urhammer, S., Lember, M., Marandi, T., Uuetoa, T., Airaksinen, J., Honkaniemi, J., Kaaja, R., Lassila, R., Saarinen, J., Tatlisumak, T., Vikman, S., Agraou, B., Aquilanti, S., Belhassane, A., Brisot, D., De Geeter, G., Debourdeau, P., Decoulx, E., El Kouri, D., Falvo, N., Grange, C., Lacroix, P., Messas, E., Mismetti, P., Montaclair, K., Mottier, D., Paleiron, N., Payot, L., Pernod, G., Pottier, P., Proust, A., Quere, I., Roy, P. -M., Schmidt, J., Simoneau, G., Datikashvili-David, I., Khabeishvili, G., Khintibidze, I., Kobulia, B., Megreladze, I., Pagava, Z., Paposhvili, K., Shaburishvili, T., Amann, B., Berrouschot, J., Beyer-Westendorf, J., Blessing, E., Bott, M., Dengler, T., Diehm, C., Dziewas, R., Genth-Zotz, S., Hamann, F., Horacek, T., Klimpe, S., Kroning, R., Lapp, H., Lawall, H., Licka, M., Rizos, T., Schellong, S., Schmidt-Lucke, J., Singer, C., Tiefenbacher, C., Veltkamp, R., Weimar, C., Zeymer, U., Alkonyi, B., Falukozy, J., Futo, L., Katona, A., Kirschner, R., Kristof, P., Lakatos, F., Laszlo, Z., Lupkovics, G., Merkely, B., Nagy Andras, C., Nemeth, L., Papp, A., Soltesz, P., Sudar, Z., Szabo, G., Szegedi, N., Timar, G., Valco, J., Vertes, A., Efrati, S., Elias, M., Gafter, A., Hayek, T., Hussein, O., Lishner, M., Lugassy, G., Zeltser, D., Ageno, W., Cerveri, I., D'Angelo, A., De Pellegrin, A., Imberti, D., Landolfi, R., Lembo, G., Lodigiani, C., Luisetti, M., Moia, M., Molteni, M., Mumoli, N., Novo, S., Orlandini, F., Parisi, R., Pizzini, A., Pomero, F., Salvi, A., Schenone, A., Visona, A., Krievins, D., Martinova, V., Pontaga, N., Rozitis, V., Stukena, I., Alekniene, B., Bagdonas, A., Basijokiene, V., Butkiene, Z., Griskeviciene, V., Naudziunas, A., Norvaisiene, R., Norviliene, R., Petrauskiene, R., Poskiene, R., Susinskiene, D., Valavicius, A., Castillo Leon, R., Cotrina Pereyra, R., Farjardo Karlo, L., Horna, M., Lema Osores, J., Salas, M., Toche Yanez, L., Fryze, W., Gaciong, Z., Gniot, J., Gorecka, D., Gruenpeter, P., Grzelakowski, P., Jastrzebski, D., Kucharski, L., Mirek-Bryniarska, E., Pulkowski, G., Sobkowicz, B., Sulik, P., Tomkowski, W., Walasek, L., Waldemar, K., Wrzesinski, K., Balogh, Z. E., Bojinca, M., Marin, I., Mot, S., Musetescu, R., Podoleanu, C., Popescu, M., Stamate, S., Stanciulescu, G., Vida-Simiti, L., Abashev, A., Andreev, D., Apartsin, K., Arkhipov, M., Averkov, O., Barbarash, O., Belskaya, G., Bogdanov, E., Boldueva, S., Chefranova, Z., Dovgalevskiy, Y., Ershova, O., Goloshchekin, B., Khachatryan, N., Khurs, E., Klein, G., Kobalava, Z., Kosmacheva, E., Kostenko, V., Malygin, A., Martynenko, T., Martynenko, V., Maslova, N., Mordovin, V., Nikolaev, K., Nilk, R., Panchenko, E., Popov, D., Privalova, E., Reshetko, O., Sergeeva, E., Shapovalova, Y., Shpagina, L., Shvarts, Y., Simanenkov, V., Solovyov, O., Vishneva, E., Vishnevskiy, A., Apostolovic, S., Celic, V., Ilic, S., Kovacevic-Kuzmanovic, A., Miloradovic, V., Tan, R. S., Bodikova, S., Cervenakova, A., Dvorak, M., Gaspar, L., Herman, O., Hrubon, A., Kokles, M., Krastev, G., Payer, J., Prokop, D., Spisakova, M., Adler, D., Basson, M., Breedt, J., Engelbrecht, J., Jacobson, B., Mitha, I., Van Dyk, C., Alvarez Sala, L. A., Barbagelata Lopez, C., Bisbe, J., Castro Guardiola, A., Cepeda, J. M., Cereto, F., Diaz Santos, E., Ferrer, R., Gomez Cerezo, J., Gonzales-Porras, J. R., Grandes, J., Jimenez, D., Martin Loeches, I., Mellibovsky, L., Richart, C., Riera, A., Trujillo, J., Vargas Nunez, J. A., Villalta, J., Akgul, O., Guneri, S., Kilichesmez, K., Kirma, C., Kutluk, H., Nazliel, B., Okumus, G., Ongen, G., Tigen, K., Topcuoglu, M., Tuncay, E., Abrahamovych, O., Batushkin, V., Brozhyk, J., Burmak, I., Godlevska, O., Goloborodko, A., Goloborodko, B., Goncharova, Y., Gryb, V., Karpenko, O., Kopytsya, M., Koshlia, V., Krakhmalova, O., Kyrychenko, I., Legkonogov, O., Malynovsky, Y., Maslovaskyi, V., Nikonov, V., Parkhomenko, O., Perepeliuk, M., Reshotko, D., Rudenko, L., Ryabichenko, T., Svyridova, I., Svyshchenko, Y., Tseluyko, V., Ursol, G., Vakaliuk, I., Vishnivestsky, I., Voronkov, L., Yagensky, A., Body, R., Chandra, D., Davis, M., Kesteven, P., Maccallum, P., Mccollum, C., Natarajan, I., Almasri, E., Amin, M., Anderson, C., Baker, S., Barney, J., Bastani, B. B. A., Bercz, P., Bidair, M., Carman, T., Chang, H., Clark, C., Concha, M., Cornell, J., Dhingra, R., Doshi, A., Ebrahimi, R., Farley, B., Fermann, G., Foster, G., Fraiz, J., Fulmer, J., Gaggin, H., Goytia-Leos, D., Hahn, B., Haidar, A., Hamad, A., Hazelrigg, M., Ioachimescu, O., Johnson, B., Kabler, H., Kao, C. -K., Kazimir, M., Kouras, F., Kung, M., Lerner, R., Lopez, J., Macchiavelli, A., Mahal, S., Margolis, B., Mclaren, G., Milling, T., Mittal, M., Nadar, V., Ohaju, V., Ortel, T., Overcash, J., Parthiban, K., Pearl, R., Pineda, L., Pratt, R., Pullman, J., Quintana, O., Rajan, R., Rastogi, P., Rees, C., Rodriguez, W., Saba, F., Shammas, N., Sharma, S., Sokol, S., Stoltz, S., Subich, D., Tuck, M., Updegrove, J., Warner, A., Welch, M., Welker, J., Whitman, B., Wichman, T., Yousef, K., Yusen, R., and Zakai, N.

Subjects
Male, pulmonary embolism, Time Factors, Pyridines, Intracranial hemorrhage, Kaplan-Meier Estimate, 030204 cardiovascular system & hematology, law.invention, chemistry.chemical_compound, 0302 clinical medicine, Randomized controlled trial, law, Risk Factors, Clinical Studies, Medicine, 030212 general & internal medicine, Myocardial infarction, Original Research, Ischemic stroke, Hazard ratio, Absolute risk reduction, Venous Thromboembolism, Middle Aged, Interventional Cardiology, Pulmonary embolism, Death, myocardial infarction, Treatment Outcome, Cardiovascular Diseases, Anesthesia, Acute Disease, Benzamides, Number needed to treat, Female, Cardiology and Cardiovascular Medicine, Intracranial Hemorrhages, Adult, venous thromboembolism, Hemorrhage, 03 medical and health sciences, Double-Blind Method, death, ischemic stroke, Humans, Enoxaparin, Aged, Proportional Hazards Models, Inpatients, Venous thromboembolism, business.industry, Settore MED/09 - MEDICINA INTERNA, Anticoagulants, Thrombosis, medicine.disease, Clinical trial, chemistry, Betrixaban, business, Acute Coronary Syndromes, intracranial hemorrhage, Factor Xa Inhibitors
Abstract

Background Extended‐duration betrixaban showed a significant reduction in venous thromboembolism in the APEX trial (Acute Medically Ill VTE Prevention With Extended Duration Betrixaban Study). Given the variable clinical impact of different efficacy and safety events, one approach to assess net clinical outcomes is to include only those events that are either fatal or cause irreversible harm. Methods and Results This was a post hoc analysis of the APEX trial—a multicenter, double‐blind, randomized controlled trial comparing extended‐duration betrixaban versus standard‐of‐care enoxaparin. A composite of all fatal or irreversible safety (fatal bleeding or intracranial hemorrhage) and efficacy events (cardiopulmonary death, myocardial infarction, pulmonary embolism, and ischemic stroke) was evaluated in a time‐to‐first event analysis. In patients with positive D‐dimer results, betrixaban reduced fatal or irreversible events at 35 to 42 days (4.80% versus 3.54%; hazard ratio, 0.73; absolute risk reduction, 1.26%; number needed to treat, 79 [ P =0.033]) and at study end at 77 days (6.27% versus 4.36%; hazard ratio, 0.70; absolute risk reduction, 1.91%; number needed to treat, 52 [ P =0.005]) versus enoxaparin. In all patients, betrixaban reduced fatal or irreversible events at 35 to 42 days (4.08% versus 2.90%; hazard ratio, 0.71; absolute risk reduction, 1.18%; number needed to treat, 86 [ P =0.006]) and 77 days (5.17% versus 3.64%; hazard ratio, 0.70; absolute risk reduction, 1.53%; number needed to treat, 65 [ P =0.002]). Conclusions Among hospitalized medically ill patients, extended‐duration betrixaban demonstrated an ≈30% reduction in fatal or irreversible ischemic or bleeding events compared with standard‐duration enoxaparin. A total of 65 patients would require treatment with betrixaban to prevent 1 fatal or irreversible event versus enoxaparin. Clinical Trial Registration URL : http://www.ClinicalTrials.gov . Unique identifier: NCT 01583218.

Published
2017

16. Serum concentrations of cholesterol, apolipoprotein A-I, and apolipoprotein B in a total of 1 694 meat-eaters, fish-eaters, vegetarians, and vegans

Author

Bradbury, K, Crowe, F, Appleby, P, Schmidt, J, Travis, R, and Key, T

Subjects
Adult, Dietary Fiber, Male, medicine.medical_specialty, Meat, Apolipoprotein B, Alcohol Drinking, vegetarian diet, Medicine (miscellaneous), Article, Body Mass Index, lipids, chemistry.chemical_compound, Internal medicine, medicine, Animals, Humans, Exercise, Apolipoproteins B, Nutrition and Dietetics, biology, Apolipoprotein A-I, Cholesterol, business.industry, Diet, Vegetarian, Cholesterol, HDL, Fishes, food and beverages, cholesterol, Cholesterol hdl, Apolipoproteins b, vegan diet, Serum concentration, Cholesterol blood, Diet, Endocrinology, Cross-Sectional Studies, chemistry, biology.protein, %22">Fish , Dietary fiber, Female, lipids (amino acids, peptides, and proteins), business, Energy Intake, apolipoproteins
Abstract

Background/Objectives: The objective of this study was to describe serum lipid concentrations, including apolipoproteins A-I and B, in different diet groups. Subjects/Methods: A cross-sectional analysis of a sample of 424 meat-eaters, 425 fish-eaters, 423 vegetarians and 422 vegans, matched on sex and age, from the European Prospective Investigation into Cancer and Nutrition-Oxford cohort. Serum concentrations of total, and high-density lipoprotein (HDL) cholesterol, as well as apolipoproteins A-I and B were measured, and serum non-HDL cholesterol was calculated. Results: Vegans had the lowest body mass index (BMI) and the highest and lowest intakes of polyunsaturated and saturated fat, respectively. After adjustment for age, alcohol and physical activity, compared with meat-eaters, fish-eaters and vegetarians, serum concentrations of total and non-HDL cholesterol and apolipoprotein B were significantly lower in vegans. Serum apolipoprotein A-I concentrations did not differ between the diet groups. In males, the mean serum total cholesterol concentration was 0.87 nmol/l lower in vegans than in meat-eaters; after further adjustment for BMI this difference was 0.76 nmol/l. In females, the difference in total cholesterol between these two groups was 0.60 nmol/l, and after further adjustment for BMI was 0.55 nmol/l. Conclusions: In this study, which included a large number of vegans, serum total cholesterol and apolipoprotein B concentrations were lower in vegans compared with meat-eaters, fish-eaters and vegetarians. A small proportion of the observed differences in serum lipid concentrations was explained by differences in BMI, but a large proportion is most likely due to diet.

Published
2013

17. Electrophysiologic monitoring in acute brain injury

Author

Claassen J., Vespa P., Le Roux P., Menon D. K., Citerio G., Bader M. K., Brophy G. M., Diringer M. N., Stocchetti N., Videtta W., Armonda R., Badjatia N., Boesel J., Chesnut R., Chou S., Czosnyka M., De Georgia M., Figaji A., Fugate J., Helbok R., Horowitz D., Hutchinson P., Kumar M., McNett M., Miller C., Naidech A., Oddo M., Olson D., O'Phelan K., Provencio J., Puppo C., Riker R., Robertson C., Schmidt J. M., Taccone F., Claassen, J, Vespa, P, Le Roux, P, Menon, D, Citerio, G, Bader, M, Brophy, G, Diringer, M, Stocchetti, N, Videtta, W, Armonda, R, Badjatia, N, Boesel, J, Chesnut, R, Chou, S, Czosnyka, M, De Georgia, M, Figaji, A, Fugate, J, Helbok, R, Horowitz, D, Hutchinson, P, Kumar, M, Mcnett, M, Miller, C, Naidech, A, Oddo, M, Olson, D, O'Phelan, K, Provencio, J, Puppo, C, Riker, R, Robertson, C, Schmidt, J, and Taccone, F

Subjects
medicine.medical_specialty, Neurology, Critical Care, Traumatic brain injury, Ischemia, Electroencephalography, Critical Care and Intensive Care Medicine, EEG-fMRI, law.invention, Brain Ischemia, law, Seizures, medicine, Humans, Evoked potential, medicine.diagnostic_test, business.industry, Patient Selection, medicine.disease, Intensive care unit, Heart Arrest, Bispectral index, Electroencephalography, Evoked potential, Ischemia, Prognosis, Quantitative EEG, Seizure, Bispectral index, Anesthesia, Brain Injuries, Emergency medicine, Neurology (clinical), business
Abstract

To determine the optimal use and indications of electroencephalography (EEG) in critical care management of acute brain injury (ABI). An electronic literature search was conducted for articles in English describing electrophysiological monitoring in ABI from January 1990 to August 2013. A total of 165 studies were included. EEG is a useful monitor for seizure and ischemia detection. There is a well-described role for EEG in convulsive status epilepticus and cardiac arrest (CA). Data suggest EEG should be considered in all patients with ABI and unexplained and persistent altered consciousness and in comatose intensive care unit (ICU) patients without an acute primary brain condition who have an unexplained impairment of mental status. There remain uncertainties about certain technical details, e.g., the minimum duration of EEG studies, the montage, and electrodes. Data obtained from both EEG and EP studies may help estimate prognosis in ABI patients, particularly following CA and traumatic brain injury. Data supporting these recommendations is sparse, and high quality studies are needed. EEG is used to monitor and detect seizures and ischemia in ICU patients and indications for EEG are clear for certain disease states, however, uncertainty remains on other applications.

Published
2014

18. Monitoring of brain and systemic oxygenation in neurocritical care patients

Author

Oddo M., Bosel J., Le Roux P., Menon D. K., Vespa P., Citerio G., Bader M. K., Brophy G. M., Diringer M. N., Stocchetti N., Videtta W., Armonda R., Badjatia N., Chesnut R., Chou S., Claassen J., Czosnyka M., De Georgia M., Figaji A., Fugate J., Helbok R., Horowitz D., Hutchinson P., Kumar M., McNett M., Miller C., Naidech A., Olson D., O'Phelan K., Provencio J., Puppo C., Riker R., Robertson C., Schmidt J. M., Taccone F., Oddo, M, Bosel, J, Le Roux, P, Menon, D, Vespa, P, Citerio, G, Bader, M, Brophy, G, Diringer, M, Stocchetti, N, Videtta, W, Armonda, R, Badjatia, N, Chesnut, R, Chou, S, Claassen, J, Czosnyka, M, De Georgia, M, Figaji, A, Fugate, J, Helbok, R, Horowitz, D, Hutchinson, P, Kumar, M, Mcnett, M, Miller, C, Naidech, A, Olson, D, O'Phelan, K, Provencio, J, Puppo, C, Riker, R, Robertson, C, Schmidt, J, Taccone, F, and Participants in the International Multidisciplinary Consensus Conference on Multimodality Monitoring

Subjects
medicine.medical_specialty, Neurology, Critical Care, Intracranial Pressure, business.industry, Traumatic brain injury, Neurointensive care, Reproducibility of Results, Brain Hypoxia, Oxygenation, Critical Care and Intensive Care Medicine, medicine.disease, Prognosis, Neurophysiological Monitoring, Brain oxygen, Carbon dioxide, Jugular oxygen saturation, Near-infrared spectroscopy, Neurocritical care, Systemic oxygenation, Oxygen monitoring, Intensive care, Brain Injuries, Medicine, Humans, Neurology (clinical), Oximetry, Cerebral perfusion pressure, business, Intensive care medicine
Abstract

Maintenance of adequate oxygenation is a mainstay of intensive care, however, recommendations on the safety, accuracy, and the potential clinical utility of invasive and non-invasive tools to monitor brain and systemic oxygenation in neurocritical care are lacking. A literature search was conducted for English language articles describing bedside brain and systemic oxygen monitoring in neurocritical care patients from 1980 to August 2013. Imaging techniques e.g., PET are not considered. A total of 281 studies were included, the majority described patients with traumatic brain injury (TBI). All tools for oxygen monitoring are safe. Parenchymal brain oxygen (PbtO2) monitoring is accurate to detect brain hypoxia, and it is recommended to titrate individual targets of cerebral perfusion pressure (CPP), ventilator parameters (PaCO2, PaO2), and transfusion, and to manage intracranial hypertension, in combination with ICP monitoring. SjvO2 is less accurate than PbtO2. Given limited data, NIRS is not recommended at present for adult patients who require neurocritical care. Systemic monitoring of oxygen (PaO2, SaO2, SpO2) and CO2 (PaCO2, end-tidal CO2) is recommended in patients who require neurocritical care.

Published
2014

19. Intracranial pressure monitoring: fundamental considerations and rationale for monitoring

Author

Chesnut R., Videtta W., Vespa P., Le Roux P., Menon D. K., Citerio G., Bader M. K., Brophy G. M., Diringer M. N., Stocchetti N., Armonda R., Badjatia N., Boesel J., Chou S., Claassen J., Czosnyka M., De Georgia M., Figaji A., Fugate J., Helbok R., Horowitz D., Hutchinson P., Kumar M., McNett M., Miller C., Naidech A., Oddo M., Olson D., O'Phelan K., Provencio J., Puppo C., Riker R., Robertson C., Schmidt J. M., Taccone F., Chesnut, R, Videtta, W, Vespa, P, Le Roux, P, Menon, D, Citerio, G, Bader, M, Brophy, G, Diringer, M, Stocchetti, N, Armonda, R, Badjatia, N, Boesel, J, Chou, S, Claassen, J, Czosnyka, M, De Georgia, M, Figaji, A, Fugate, J, Helbok, R, Horowitz, D, Hutchinson, P, Kumar, M, Mcnett, M, Miller, C, Naidech, A, Oddo, M, Olson, D, O'Phelan, K, Provencio, J, Puppo, C, Riker, R, Robertson, C, Schmidt, J, and Taccone, F

Subjects
medicine.medical_specialty, Neurology, Critical Care, Intracranial Pressure, Traumatic brain injury, Physical examination, Critical Care and Intensive Care Medicine, medicine, Humans, Brain injury, Cerebral perfusion pressure, Coma, Intracranial pressure, Multimodality monitoring, Cerebral perfusion pressure, Intensive care medicine, Neurophysiological Monitoring, Intracranial pressure, integumentary system, medicine.diagnostic_test, business.industry, musculoskeletal, neural, and ocular physiology, Patient Selection, medicine.disease, Prognosis, nervous system diseases, Brain Injuries, Intracranial pressure monitoring, Observational study, Neurology (clinical), business
Abstract

Traumatic brain injury (TBI) is a major cause of death and disability worldwide. In large part critical care for TBI is focused on the identification and management of secondary brain injury. This requires effective neuromonitoring that traditionally has centered on intracranial pressure (ICP). The purpose of this paper is to review the fundamental literature relative to the clinical application of ICP monitoring in TBI critical care and to provide recommendations on how the technique maybe applied to help patient management and enhance outcome. A PubMed search between 1980 and September 2013 identified 2,253 articles; 244 of which were reviewed in detail to prepare this report and the evidentiary tables. Several important concepts emerge from this review. ICP monitoring is safe and is best performed using a parenchymal monitor or ventricular catheter. While the indications for ICP monitoring are well established, there remains great variability in its use. Increased ICP, particularly the pattern of the increase and ICP refractory to treatment is associated with increased mortality. Class I evidence is lacking on how monitoring and management of ICP influences outcome. However, a large body of observational data suggests that ICP management has the potential to influence outcome, particularly when care is targeted and individualized and supplemented with data from other monitors including the clinical examination and imaging.

Published
2014

20. Multimodality monitoring consensus statement: monitoring in emerging economies

Author

Figaji A., Puppo C., Le Roux P., Menon D. K., Vespa P., Citerio G., Bader M. K., Brophy G. M., Diringer M. N., Stocchetti N., Videtta W., Armonda R., Badjatia N., Boesel J., Chesnut R., Chou S., Claassen J., Czosnyka M., De Georgia M., Fugate J., Helbok R., Horowitz D., Hutchinson P., Kumar M., McNett M., Miller C., Naidech A., Oddo M., Olson D., O'Phelan K., Provencio J., Riker R., Robertson C., Schmidt J. M., Taccone F., Figaji, A, Puppo, C, Le Roux, P, Menon, D, Vespa, P, Citerio, G, Bader, M, Brophy, G, Diringer, M, Stocchetti, N, Videtta, W, Armonda, R, Badjatia, N, Boesel, J, Chesnut, R, Chou, S, Claassen, J, Czosnyka, M, De Georgia, M, Fugate, J, Helbok, R, Horowitz, D, Hutchinson, P, Kumar, M, Mcnett, M, Miller, C, Naidech, A, Oddo, M, Olson, D, O'Phelan, K, Provencio, J, Riker, R, Robertson, C, Schmidt, J, and Taccone, F

Subjects
medicine.medical_specialty, Consensus, Critical Care, media_common.quotation_subject, Developing country, Context (language use), Critical Care and Intensive Care Medicine, Multimodality, Resource (project management), Clinical Protocols, Health care, medicine, Developing countries, Low- and middle-income countries, Multimodality monitoring, Neurocritical care, Traumatic brain injury, Humans, Quality (business), Intensive care medicine, Emerging markets, Developing Countries, media_common, business.industry, Patient Selection, Neurointensive care, medicine.disease, Neurophysiological Monitoring, Brain Injuries, Neurology (clinical), Medical emergency, business
Abstract

The burden of disease and so the need for care is often greater at hospitals in emerging economies. This is compounded by frequent restrictions in the delivery of good quality clinical care due to resource limitations. However, there is substantial heterogeneity in this economically defined group, such that advanced brain monitoring is routinely practiced at certain centers that have an interest in neurocritical care. It also must be recognized that significant heterogeneity in the delivery of neurocritical care exists even within individual high-income countries (HICs), determined by costs and level of interest. Direct comparisons of data between HICs and the group of low- and middle-income countries (LAMICs) are made difficult by differences in patient demographics, selection for ICU admission, therapies administered, and outcome assessment. Evidence suggests that potential benefits of multimodality monitoring depend on an appropriate environment and clinical expertise. There is no evidence to suggest that patients in LAMICs where such resources exist should be treated any differently to patients from HICs. The potential for outcome benefits in LAMICs is arguably greater in absolute terms because of the large burden of disease; however, the relative cost/benefit ratio of such monitoring in this setting must be viewed in context of the overall priorities in delivering health care at individual institutions.

Published
2014

21. The management of acute venous thromboembolism in clinical practice. Results from the European PREFER in VTE Registry

Author

Cohen, At, Gitt, Ak, Bauersachs, R, Fronk, Em, Laeis, P, Mismetti, P, Monreal, M, Willich, Sn, Bramlage, P, Agnelli, G, Brodmann, M, Rief, P, Eischer, L, Stoshikj, S, Hirschl, M, Weinmann, S, Peter Marschang, P, Abbadie, F, Achkar, A, Addala, A, Reynaldo, P, Adnet, F, Alexandra, Jf, Aquilanti, S, Belhassane, A, Benaroya, B, Berremili, T, Grenot, Mc, Birr, V, Holtea, D, Bonnin, C, Bosler, F, Bresin Durand MG, Brisot, D, Brousse, C, De La Fuente, T, Cayman, C, Cazaubon, M, Champion, O, Chanut, M, Chevalet, P, Connault, J, Durant, C, Constans, J, Cordeanu, M, Couturaud, F, Lacut, K, De Dedker, L, Piloquet, Fx, Decoulx, E, Derrien, B, Diamand, Jm, Diard, A, Douadi, Y, Dupas, S, Modeliar Remond SS, Sevestre, Ma, Edhery, S, Falvo, N, Farcas Taralunga, C, Ferrari, E, Gaillard, C, Garrigues, D, Gillet, Jl, Giordana, P, Grange, C, Vital-Durand, D, Grare, F, Hadj Henni, A, Heuser, S, Schmidt, J, Hidden-Henic, V, Hottin, D, Imbert, B, Pernod, G, Jakob, D, Jacquinandi, V, Jurus, C, Lacoste, A, Laroche, Jp, Martin, M, Mazollier, C, Mersel, T, Miserey, G, Nedey, C, Nou, M, Quere, I, Ouvry, P, Peuch, B, Pichot, O, Poulain, V, Ray, P, Rifai, A, Roy, Pm, Saby, Jc, Simon, F, Simonot-Lalandec, E, Stephan, D, Tissot, A, Vodoungnon, H, Adamczyk, A, Schnabl, S, Al Ahmad, W, Weber, H, Axthelm, C, Axthelm, P, Bergmann, K, Beschorner, U, Knittel, M, Binias, Kh, Pasligh, M, Boral, M, Girke, F, Bratsch, H, Brauer, G, Burghard, S, Demann, C, Rennebaum, C, Emter, E, Demmig, A, Eberlein, U, Enger, F, Eschenburg, J, Eschenburg, Ju, Forkmann, L, Frank, J, Freischmidt, H, Gassauer, M, Fritsche, I, Kubicek–hofmann, C, Goebels, Mc, Guggenbichler, S, Härtel, D, Hartmann, K, Heilberger, P, Heinsius, A, Held, M, Schnupp, S, Herman, G, Herold, J, Hertrich, F, Hommel, H, Hütte, G, Kalka, C, Jungandreas, K, Ramthor, M, Karcher, J, Werner, N, Karl-Wollweber, S, Keilhau, Da, Kittel, K, Knolinski, T, Köhler, C, Werth, S, Kopplin, U, Körner, I, Wittig, K, Dres, P, Kröger, K, Moysidis, T, Kroschel, U, Leschke, M, zur Nieden, T, Lübbert, G, Lutz, A, Wucherpfennig, P, Marencke, Gh, Mortensen, K, Reppel, M, Nelles, H, Nestler, K, Neumeister, A, Schlosser, A, Oettler, W, Ott, I, Otto, A, Pertermann, A, Pfister, R, Pindur, P, Pourhassan, S, Predel, D, Pudollek, T, Reimer, D, Richter, R, Eberhad Rieker, E, Rothenbücher, G, Rothhagen, B, Rudolff, S, Stücker, M, Schäfer, A, Sonnenschein, K, Schafnitzl, W, Schellong, S, Voigts, B, Schiller, M, Schmeink, T, Schmeink, P, Schneider, H, Schön, N, Schulze, M, Sechtem, U, Sedl, S, Werno, Hs, Stachowitz, J, Thieme, M, Tiefenbacher, C, Tsantilas, D, Vieth, P, vom Dahl, J, Grün-Himmelmann, K, von Bilderling, P, von Maltik, T, Weinrich, K, Weyer, M, Wirtz, P, Wittig, I, Zierock, P, Ageno, W, Caprioli, C, Rancan, E, Guercini, F, Mommi, V, Amitrano, M, Cannavacciuolo, F, Amore, M, D'Antoni, S, Angelini, E, La Forgia, S, Antignani, Pl, Calandra, G, Arone, A, Perticone, F, Sciacqua, A, Asaro, G, Bellisi, M, Attanzio, Mt, Pinto, A, Attinasi, V, Cillari, E, Sorvillo, S, Balbarini, A, Santini, C, Violo, C, Banfi, E, Lodigiani, C, Barcellona, D, Delpin, S, Marongiu, S, Barillari, G, Pasca, S, Bartolini, C, Verdecchia, P, Bartone, M, Mancuso, G, Bellanuova, I, Felis, S, Bellizzi, A, Masotti, L, Bianchi, M, Carugati, A, Bianchini, G, Guarnera, G, Boari, B, Gallerani, M, Pasin, M, Bortoluzzi, C, Parisi, R, Brucoli, C, Palasciano, G, Camporese, G, Tonello, C, Canafoglia, L, Rupoli, S, Cancellieri, E, Paoletti, O, Testa, S, Carlizza, A, Carnovali, M, Sada, S, Samaden, A, Casarsa, C, Mearelli, F, Pivetti, G, Catalini, R, Zingaretti, O, Cavazza, S, Cosmi, B, Cenci, C, Prisco, D, Silvestri, E, Ceresa, F, Patanè, F, Ciampa, A, Siniscalchi, V, Ciarambino, T, De Bartolomeo, G, Clemente, M, Conti, F, Paiella, L, D’Avino, M, D'Alessandro, A, Placentino, M, Sollazzo, V, D'Angelo, A, Viganò, S, De Campora, P, Sangiuolo, R, De Franciscis, S, Serra, R, De Gaudenzi, E, De Santis, F, Piccinni, Gc, De Tommaso, I, Di Francesco, L, Vincentelli, Gm, Di Maggio, R, Saccullo, G, Siragusa, S, Di Micco, P, Fontanella, A, Di Michele, D, Di Minno, G, Tufano, A, Di Nisio, M, Porreca, E, Donadio, F, Imberti, D, Enea, I, Fabbian, F, Manfredini, R, Pala, P, Falanga, A, Milesi, V, Fiore, V, Signorelli, Ss, Franco, E, Giudice, G, Frausini, G, Rovinelli, M, Fuorlo, M, Landolfi, R, Morretti, T, Gamberini, S, Salmi, R, Ghirarduzzi, A, Ghizzi, G, Pepe, C, Gianniello, F, Martinelli, I, Iosub, Di, Piovella, F, Iozzi, E, Talerico, A, La Regina, M, Orlandini, F, Marconi, L, Palla, A, Marcucci, R, Poli, D, Margheriti, R, Sala, G, Marra, A, Marrocco, F, Montagna, Es, Silvestris, F, Vallarelli, S, Mos, L, Rossetto, V, Mugno, F, Di Salvo, M, Nitti, C, Pennacchioni, M, Salvi, A, Olivieri, O, Tosi, F, Zorzi, F, Onesta, M, Pagliara, V, Villalta, S, Paolucci, G, Severino, S, Pierri, F, Russo, V, Pizzini, Am, Quintavalla, R, Rubino, P, Ria, L, Schenone, A, Strafino, C, Tropeano, P, Vetrano, V, Zanatta, N, Adarraga Cansino MD, Gutierrez, Ja, de las Revillas FA, Amado Fernández, C, Calvo Mijares, N, Blanco-Molina, Ma, Garcia, Ma, Joya Seijo, D, Aranda Blazquez, R, López-Sáez, Jb, Arellano Rodrigo, E, Villalta Blanch, J, Armengou Arxe, A, García-Bragado Dalmau, F, Ballaz Quincoces, A, García Loizaga, A, Beato Pérez JL, Bedate Díaz, P, Quezada Loaiza, A, Castellote, Mc, Cañas Alcántara, I, Lluís Padierna, M, Carrasco Expósito, M, Millón Caño JA, Carrasco Mas, A, Cereto Castro, F, Castrodeza Sanz, R, Ortiz de Saracho, J, Cisneros de la Fuente, E, de Ancos Aracil, C, Ruiz, J, de Daborenea González MD, Fernández Iglesias, A, de la Fuente Aguado, J, González, Lg, del Carmen Fernández-Capitán, M, Lorenzo Hernández, A, del Toro Cervera, J, Pérez Rus, G, Delgado Bregel JL, Díez Fernández, F, Santalla Valle EA, Elias Hernández, T, Jara Palomares, L, Ferri Bataler, R, Nieto Rodríguez JA, García García JM, Villanueva Montes MA, González Porras JR, Guil García, M, San Román Terán CM, Hernando López, E, Roncero Lázaro, A, Jaras, Mj, Jiménez Castro, D, Jiménez-Rodríguez Madridejos, R, Pedrajas Navas JM, Lecumberri, R, Martínez, N, López Castellanos GT, Manzano Espinosa, L, López Jiménez, L, Madridano Cobo, O, Mainez Saiz, C, Romero Pizarro, Y, Marchena Yglesias PJ, Martín del Pozo, M, Melibovsky, L, Altarriba, Es, Monreal Bosch, M, Monte Secades, R, Mora Luján JM, Riera Mestre, A, Moral Moral, P, Todolí Parra JA, Moreno Flores, A, Sánchez Muñoz-Torrero JF, Muñoz Rodríguez FJ, Núñez Fernández MJ, Oncala Sibajas, E, Vaquero de Sedas, M, Parra Caballero, P, Pons Martín del Campo, I, Portillo Sánchez, J, Rivera Gallego, A, Villaverde Álvarez, I, Rodríguez Beltrán EM, Sánchez Fuentes, D, Roldán Schilling, V, Sánchez Álvarez, J, López, Gt, Suriñach Caralt JM, Tirado Miranda, R, Usandizaga de Antonio, E, Banyai, M, Frank, U, Jörg, Gr, Jeanneret, C, Staub, D, Ackroyd, A, Agarwal, G, Mearns, B, Alikhan, R, Allameddine, A, Al-Refaie, F, Arden, C, Austin, A, Bakhai, A, Barton, T, Ewad, H, Body, R, Thachil, J, Chacko, J, Chandra, D, Charters, F, Church, A, Mcgrane, F, Clements, J, Clifford, P, Cox, D, Crouch, M, Crowther, M, Davies, E, Davies, M, Dimitri, S, Drebes, A, Franklin, S, George, J, Irvine, N, Gerofke, H, Gibbs, C, Goh, T, Gupta, S, Holmes, J, Jackson-Voyzey, E, Jones, N, Kallat, A, Kerr, P, Kesteven, P, Lench, T, Lester, W, Lowe, G, Lewis, M, Mccormack, T, Mccoye, A, Moriarty, A, Morris, W, Narayanan, M, Oo, N, Reed, M, Rose, P, Saja, K, Sivakumaran, M, Sohal, M, Solomons, G, Sultanzadeh, Sj, Venton, T, Wakeling, J, Walby, C, Waldron, M, Watt, S, Willcock, W, and Zafar, A.

Subjects
Male, Time Factors, Databases, Factual, Administration, Oral, Disease, Comorbidity, 030204 cardiovascular system & hematology, registry, Direct oral anticoagulants, 0302 clinical medicine, Recurrence, Risk Factors, Epidemiology, 030212 general & internal medicine, Prospective Studies, Registries, anticoagulation, LS4_7, Venous Thrombosis, Hematology, Venous Thromboembolism, Vitamin K antagonist, Middle Aged, Thrombosis, Pulmonary embolism, Europe, vitamin K antagonists, Treatment Outcome, Administration, Female, Coagulation and Fibrinolysis, Venous thromboembolism, Oral, Adult, medicine.medical_specialty, Registry, medicine.drug_class, Socio-culturale, Hemorrhage, direct oral anticoagulants, Venous thromboembolism, anticoagulation, direct oral anticoagulants, registry, vitamin K antagonists, Anticoagulation, Vitamin K antagonists, Aged, Anticoagulants, Humans, Pulmonary Embolism, 03 medical and health sciences, Databases, Disease registry, Internal medicine, medicine, cardiovascular diseases, Intensive care medicine, Factual, business.industry, medicine.disease, equipment and supplies, Clinical trial, business
Abstract

SummaryVenous thromboembolism (VTE) is a significant cause of morbidity and mortality in Europe. Data from real-world registries are necessary, as clinical trials do not represent the full spectrum of VTE patients seen in clinical practice. We aimed to document the epidemiology, management and outcomes of VTE using data from a large, observational database. PREFER in VTE was an international, non-interventional disease registry conducted between January 2013 and July 2015 in primary and secondary care across seven European countries. Consecutive patients with acute VTE were documented and followed up over 12 months. PREFER in VTE included 3,455 patients with a mean age of 60.8 ± 17.0 years. Overall, 53.0% were male. The majority of patients were assessed in the hospital setting as inpatients or outpatients (78.5%). The diagnosis was deep-vein thrombosis (DVT) in 59.5% and pulmonary embolism (PE) in 40.5%. The most common comorbidities were the various types of cardiovascular disease (excluding hypertension; 45.5%), hypertension (42.3%) and dyslipidaemia (21.1%). Following the index VTE, a large proportion of patients received initial therapy with heparin (73.2%), almost half received a vitamin K antagonist (48.7%) and nearly a quarter received a DOAC (24.5%). Almost a quarter of all presentations were for recurrent VTE, with >80% of previous episodes having occurred more than 12 months prior to baseline. In conclusion, PREFER in VTE has provided contemporary insights into VTE patients and their real-world management, including their baseline characteristics, risk factors, disease history, symptoms and signs, initial therapy and outcomes.

Published
2016

22. The safety and efficacy of full- versus reduced-dose betrixaban in the Acute Medically Ill VTE (Venous Thromboembolism) Prevention With Extended-Duration Betrixaban (APEX) trial

Author

Raymuno, S., Ramacciotti, E., Manenti, E., Freire, A., Fiss, E., Bizzacchi, J. Annichino, Lienart, F., Dive, A., Delforge, M., Blockmans, D., Soroka, N., Kamenova, Z., Kostadinova, M., Milanova, M., Pencheva, G., Runev, N., Stoeva, N., Stoyanov, M., Syulemzova, S., Todorov, G., Polonetsy, L., Pimanov, S., Mitkovskaya, N., Tokmakova, M., Dhar, A., Mikhailova, E., Koryk, V., Adzerikho, I., Schoenerr, H., Mathies, R., Douketis, J., Konig, J., Le Gal, G., Pearce, M., Provencher, S., Verreault, S., Alarcon, M. Arias, Lazcano, M. Opazo, Cardenas, S. Potthoff, Butkovic-Soldo, S., Car, S., Ciglenecki, N., Francetic, I., Jakopovic, M., Kalinic-Grgorinic, H., Knezevic, A., Marusic, S., Vagic, J. Sikic, Skerk, V., Cermak, O., Gibson, C. Michael, Halaby, Rim, Korjian, Serge, Daaboul, Yazan, Arbetter, Douglas F., Yee, Megan K., Chlumsky, J., Chochola, J., Cizek, V., Goldhaber, Samuel Z., Hull, Russel, Hernandez, Adrian F., Huber, K., Lu, Shiao-ping, Dunaj, M., Dusek, J., Francek, L., Havelka, J., Herold, M., Holaj, R., Nazliel, BİJEN, Bandman, Olga, Leeds, Janet M., Gold, Alex, Harrington, Robert A., Bello, F., Ferrari, A. E., Jure, H., Macin, S., Oliva, M., Parody, M., Horny, I., Hubac, J., Jajtner, P., Kolman, P., Poy, C., Baker, R., Lang, P., Mikulova, J., Podpera, I., Reiterer, P., Spacek, R., Vejvoda, J., Vyhnanek, M., Christensen, H., Lassen, M., Storgaard, M., Tuxen, C., Urhammer, S., Lember, M., Uuetoa, T., Airaksinen, J., Honkaniemi, J., Kaaja, R., Saarinen, J., Tatlisumak, T., Vikman, S., Agraou, B., Aquilanti, S., Belhassane, A., Brisot, D., De Geeter, G., Coughlin, P., Finfer, S., Debourdeau, P., Decoulx, E., El Kouri, D., Falvo, N., Grange, C., Rubinfeld, A., Lacroix, P., Messas, E., Mismetti, P., Montaclair, K., Paleiron, N., Payot, L., Zakai, N., Yousef, K., Wichman, T., Whitman, B., Welker, J., Welch, M., Warner, A., Updegrove, J., Tuck, M., Stoltz, S., Sokol, S., Sharma, S., Shammas, N., Saba, F., Rodriguez, W., Rastogi, P., Rajan, R., Quintana, O., Pullman, J., Pratt, R., Pineda, L., Pernod, G., Pearl, R., Parthiban, K., Ortel, T., Ohaju, V., Pottier, P., Proust, A., Quere, I., Roy, P-M., Schmidt, J., Simoneau, G., Datikashvili-David, I., Khabeishvili, G., Khintibidze, I., Nadar, V., Mittal, M., Milling, T., McLaren, G., Margolis, B., Mahal, S., Macchiavelli, A., Lopez, J., Lerner, R., Kung, M., Kouras, F., Kazimir, M., Kao, C-K., Kabler, H., Ioachimescu, O., Hazelrigg, M., Hamad, A., Haidar, A., Hahn, B., Goytia-Leos, D., Gaggin, H., Fulmer, J., Fraiz, J., Fermann, G., Farley, B., Doshi, A., Dhingra, R., Cornell, J., Concha, M., Clark, C., Chang, H., Carman, T., Bidair, M., Bercz, P., Bastani, A., Barney, J., Baker, S., Anderson, C., Amin, M., Almasri, E., Natarajan, I., McCollum, C., MacCallum, P., Davis, M., Body, R., Yagensky, A., Voronkov, L., Vishnivestsky, I., Vakaliuk, I., Ursol, G., Tseluyko, V., Svyshchenko, Y., Svyridova, I., Ryabichenko, T., Rudenko, L., Reshotko, D., Perepeliuk, M., Parkhomenko, O., Nikonov, V., Maslovaskyi, V., Malynovsky, Y., Legkonogov, O., Kyrychenko, I., Krakhmalova, O., Koshlia, V., Kopytsya, M., Karpenko, O., Gryb, V., Goncharova, Y., Goloborodko, B., Goloborodko, A., Godlevska, O., Burmak, I., Brozhyk, J., Batushkin, V., Abrahamovych, O., Tuncay, E., Topcuoglu, M., Tigen, K., Okumus, G., Kutluk, H., Kirma, C., Kilichesmez, K., Guneri, S., Akgul, O., Villalta, J., Vargas Nunez, J. A., Trujillo, J., Riera, A., Richart, C., Mellibovsky, L., Jimenez, D., Grandes, J., Gonzales-Porras, J. R., Gomez Cerezo, J., Ferrer, R., Diaz Santos, E., Cereto, F., Cepeda, J. M., Castro Guardiola, A., Bisbe, J., Barbagelata Lopez, C., Alvarez Sala, L. A., Van Dyk, C., Mitha, I., Engelbrecht, J., Breedt, J., Basson, M., Adler, D., Spisakova, M., Payer, J., Krastev, G., Kokles, M., Hrubon, A., Herman, O., Dvorak, M., Cervenakova, A., Bodikova, S., Miloradovic, V., Kovacevic-Kuzmanovic, A., Ilic, S., Celic, V., Apostolovic, S., Vishnevskiy, A., Vishneva, E., Solovyov, O., Simanenkov, V., Shvarts, Y., Shpagina, L., Shapovalova, Y., Sergeeva, E., Reshetko, O., Privalova, E., Popov, D., Nilk, R., Nikolaev, K., Mordovin, V., Maslova, N., Martynenko, V., Martynenko, T., Malygin, A., Kostenko, V., Kosmacheva, E., Kobalava, Z., Klein, G., Khachatryan, N., Ershova, O., Dovgalevskiy, Y., Chefranova, Z., Boldueva, S., Bogdanov, E., Belskaya, G., Barbarash, O., Averkov, O., Arkhipov, M., Apartsin, K., Andreev, D., Abashev, A., Vida-Simiti, L., Stanciulescu, G., Stamate, S., Kobulia, B., Megreladze, I., Pagava, Z., Paposhvili, K., Amann, B., Beyer-Westendorf, J., Blessing, E., Bott, M., Dengler, T., Dziewas, R., Genth-Zotz, S., Hamann, F., Horacek, T., Klimpe, S., Kroning, R., Lapp, H., Lawall, H., Licka, M., Rizos, T., Tiefenbacher, C., Weimar, C., Alkonyi, B., Falukozy, J., Futo, L., Katona, A., Kirschner, R., Kristof, P., Lakatos, F., Lupkovics, G., Merkely, B., Andras, C. Nagy, Nemeth, L., Papp, A., Soltesz, P., Sudar, Z., Szabo, G., Szegedi, N., Timar, G., Valco, J., Vertes, A., Efrati, S., Elias, M., Gafter, A., Hayek, T., Hussein, O., Lishner, M., Lugassy, G., Cerveri, I., D'Angelo, A., De Pellegrin, A., Imberti, D., Landolfi, R., Lembo, G., Lodigiani, C., Moia, M., Molteni, M., Mumoli, N., Novo, S., Orlandini, F., Parisi, R., Pizzini, A., Pomero, F., Salvi, A., Schenone, A., Visona, A., Martinova, V., Pontaga, N., Rozitis, V., Stukena, I., Alekniene, B., Basijokiene, V., Butkiene, Z., Griskeviciene, V., Naudziunas, A., Norvaisiene, R., Norviliene, R., Petrauskiene, R., Poskiene, R., Susinskiene, D., Valavicius, A., Castillo Leon, R., Pereyra, R. Cotrina, Karlo, L. Farjardo, Horna, M., Salas, M., Yanez, L. Toche, Fryze, W., Gaciong, Z., Gniot, J., Gorecka, D., Gruenpeter, P., Grzelakowski, P., Jastrzebski, D., Kucharski, L., Mirek-Bryniarska, E., Pulkowski, G., Sobkowicz, B., Sulik, P., Walasek, L., Waldemar, K., Wrzesinski, K., Balogh, Z. E., Bojinca, M., Marin, I., Musetescu, R., Podoleanu, C., Popescu, M., Kalpachki, R., Grigorov, M., Dimov, B., Rocha, A., Goloshchekin, B., Berrouschot, J., Laszlo, Z., Rees, C., Overcash, J., Prokop, D., and Cohen, Alexander T.

Subjects
Relative risk reduction, Male, Pyridines, Population, Hemorrhage, 030204 cardiovascular system & hematology, law.invention, 03 medical and health sciences, chemistry.chemical_compound, 0302 clinical medicine, Pharmacokinetics, Randomized controlled trial, Double-Blind Method, law, Medicine, Humans, 030212 general & internal medicine, Dosing, Enoxaparin, education, Aged, Aged, 80 and over, Venous Thrombosis, education.field_of_study, business.industry, Absolute risk reduction, Anticoagulants, Venous Thromboembolism, Hospitalization, chemistry, Concomitant, Betrixaban, Anesthesia, Benzamides, Female, Cardiology and Cardiovascular Medicine, business, Pulmonary Embolism, Factor Xa Inhibitors
Abstract

The APEX trial assessed the safety and efficacy of extended-duration thromboprophylaxis using betrixaban versus standard dosing of enoxaparin among hospitalized, acutely ill medical patients. The 80-mg betrixaban dose was halved to 40 mg among subjects with severe renal insufficiency and those receiving a concomitant strong P-glycoprotein inhibitor.This analysis assessed the pharmacokinetics, efficacy, and safety of full- (80 mg) and reduced-dose (40 mg) betrixaban relative to enoxaparin in the APEX trial.The median concentration of betrixaban among subjects administered the 80-mg dose was higher than that of the 40-mg dose (19 ng/mL vs 11 ng/mL, P.001). In the primary analysis cohort 1 (d-dimer ≥2× upper limit of normal), the primary efficacy outcome (asymptomatic proximal deep vein thrombosis, symptomatic proximal or distal deep vein thrombosis, symptomatic nonfatal pulmonary embolism, or venous thromboembolism-related death) was significantly reduced among subjects treated with 80 mg of extended-duration betrixaban versus enoxaparin (6.27% [95/1516] vs 8.39% [130/1549], relative risk reduction=0.26 [0.04-0.42], P=.023), and similarly in the entire primary efficacy outcome population (4.87% [122/2506] vs 7.06% [181/2562], relative risk reduction=0.30 [0.13-0.44], P=.001). There was no difference in the primary outcome for subjects treated with 40 mg betrixaban vs enoxaparin across cohorts. In addition, there was no excess of major bleeding associated with either betrixaban dose compared with enoxaparin.The 80-mg betrixaban dose achieves higher plasma concentrations than the 40-mg dose and, in contrast to the 40-mg dose, is associated with improved efficacy across all cohorts relative to standard-dose enoxaparin without an excess risk of major bleeding in the management of medically ill subjects.

Published
2016

23. Monitoring of Cerebral Blood Flow and Ischemia in the Critically Ill

Author

Miller C., Armonda R., Le Roux P., Menon D. K., Vespa P., Citerio G., Bader M. K., Brophy G. M., Diringer M. N., Stocchetti N., Videtta W., Badjatia N., Boesel J., Chesnut R., Chou S., Claassen J., Czosnyka M., De Georgia M., Figaji A., Fugate J., Helbok R., Horowitz D., Hutchinson P., Kumar M., McNett M., Naidech A., Oddo M., Olson D., O'Phelan K., Provencio J., Puppo C., Riker R., Robertson C., Schmidt J. M., Taccone F., Miller, C, Armonda, R, Le Roux, P, Menon, D, Vespa, P, Citerio, G, Bader, M, Brophy, G, Diringer, M, Stocchetti, N, Videtta, W, Badjatia, N, Boesel, J, Chesnut, R, Chou, S, Claassen, J, Czosnyka, M, De Georgia, M, Figaji, A, Fugate, J, Helbok, R, Horowitz, D, Hutchinson, P, Kumar, M, Mcnett, M, Naidech, A, Oddo, M, Olson, D, O'Phelan, K, Provencio, J, Puppo, C, Riker, R, Robertson, C, Schmidt, J, and Taccone, F

Subjects
Subarachnoid hemorrhage, Critical Care, Traumatic brain injury, Ultrasonography, Doppler, Transcranial, Ischemia, Critical Care and Intensive Care Medicine, Brain Ischemia, medicine, Neurocritical care, Humans, medicine.diagnostic_test, business.industry, Neurointensive care, Transcranial Doppler, Vasospasm, Cerebral blood flow, medicine.disease, Cerebral Angiography, Thermal diffusion flowmetry, Anesthesia, Cerebrovascular Circulation, cardiovascular system, Neurology (clinical), business, Rheology, Cerebral angiography, Multimodality monitoring
Abstract

Secondary ischemic injury is common after acute brain injury and can be evaluated with the use of neuromonitoring devices. This manuscript provides guidelines for the use of devices to monitor cerebral blood flow (CBF) in critically ill patients. A Medline search was conducted to address essential pre-specified questions related to the utility of CBF monitoring. Peer-reviewed recommendations were constructed according to the GRADE criteria based upon the available supporting literature. Transcranial Doppler ultrasonography (TCD) and transcranial color-coded duplex sonography (TCCS) are predictive of angiographic vasospasm and delayed ischemic neurological deficits after aneurysmal subarachnoid hemorrhage. TCD and TCCS may be beneficial in identifying vasospasm after traumatic brain injury. TCD and TCCS have shortcomings in identifying some secondary ischemic risks. Implantable thermal diffusion flowmetry (TDF) probes may provide real-time continuous quantitative assessment of ischemic risks. Data are lacking regarding ischemic thresholds for TDF or their correlation with ischemic injury and clinical outcomes.TCD and TCCS can be used to monitor CBF in the neurocritical care unit. Better and more developed methods of continuous CBF monitoring are needed to limit secondary ischemic injury in the neurocritical care unit.

Published
2014

24. Clinical Monitoring Scales in Acute Brain Injury: Assessment of Coma, Pain, Agitation, and Delirium

Author

Riker R. R., Fugate J. E., Le Roux P., Menon D. K., Vespa P., Citerio G., Bader M. K., Brophy G. M., Diringer M. N., Stocchetti N., Videtta W., Armonda R., Badjatia N., Boesel J., Chesnut R., Chou S., Claassen J., Czosnyka M., De Georgia M., Figaji A., Helbok R., Horowitz D., Hutchinson P., Kumar M., McNett M., Miller C., Naidech A., Oddo M., Olson D., O'Phelan K., Provencio J., Puppo C., Robertson C., Schmidt J. M., Taccone F., Riker, R, Fugate, J, Le Roux, P, Menon, D, Vespa, P, Citerio, G, Bader, M, Brophy, G, Diringer, M, Stocchetti, N, Videtta, W, Armonda, R, Badjatia, N, Boesel, J, Chesnut, R, Chou, S, Claassen, J, Czosnyka, M, De Georgia, M, Figaji, A, Helbok, R, Horowitz, D, Hutchinson, P, Kumar, M, Mcnett, M, Miller, C, Naidech, A, Oddo, M, Olson, D, O'Phelan, K, Provencio, J, Puppo, C, Robertson, C, Schmidt, J, and Taccone, F

Subjects
medicine.medical_specialty, Neurology, Critical Care, Sedation, Pain, Disorders of consciousness, Critical Care and Intensive Care Medicine, medicine, Humans, Coma, Intensive care medicine, Psychomotor Agitation, Coma, Delirium, Neurologic examination, Pain, Scale, Sedation, Neurologic Examination, Trauma Severity Indices, business.industry, Glasgow Coma Scale, Neurointensive care, Delirium, Reproducibility of Results, Pain scale, medicine.disease, Anesthesia, Brain Injuries, Neurology (clinical), medicine.symptom, business
Abstract

Serial clinical examination represents the most fundamental and basic form of neurological monitoring, and is often the first and only form of such monitoring in patients. Even in patients subjected to physiological monitoring using a range of technologies, the clinical examination remains an essential tool to follow neurological progress. Key aspects of the clinical examination have now been systematized into scoring schemes, and address consciousness, pain, agitation, and delirium (PAD). The Glasgow Coma Scale has been the traditional tool to measure consciousness, but the full outline of unresponsiveness (FOUR) score has recently been validated in a variety of settings, and at present, both represent clinically useful tools. Assessment of PAD in neurologically compromised patients present special challenges. For pain, the Numeric Rating Scale is the preferred initial approach, with either the Behavioral Pain Scale or the Critical Care Pain Observation Tool in subjects who are not able to respond. The Nociception Coma Scale-Revised may be useful in patients with severe disorders of consciousness. Conventional sedation scoring tools for critical care, such as the Richmond Area Sedation Scale (RASS) and Sedation–Agitation Scale (SAS) may provide reasonable tools in some neurocritical care patients. The use of sedative drugs and neuromuscular blockers may invalidate the use of some clinical examination tools in others. The use of sedation interruption to assess neurological status can result in physiological derangement in unstable patients (such as those with uncontrolled intracranial hypertension), and is not recommended.

Published
2014

25. Monitoring of Cerebral Autoregulation

Author

Czosnyka M., Miller C., Le Roux P., Menon D. K., Vespa P., Citerio G., Bader M. K., Brophy G. M., Diringer M. N., Stocchetti N., Videtta W., Armonda R., Badjatia N., Boesel J., Chesnut R., Chou S., Claassen J., De Georgia M., Figaji A., Fugate J., Helbok R., Horowitz D., Hutchinson P., Kumar M., McNett M., Naidech A., Oddo M., Olson D., O'Phelan K., Provencio J., Puppo C., Riker R., Robertson C., Schmidt J. M., Taccone F., Czosnyka, M, Miller, C, Le Roux, P, Menon, D, Vespa, P, Citerio, G, Bader, M, Brophy, G, Diringer, M, Stocchetti, N, Videtta, W, Armonda, R, Badjatia, N, Boesel, J, Chesnut, R, Chou, S, Claassen, J, De Georgia, M, Figaji, A, Fugate, J, Helbok, R, Horowitz, D, Hutchinson, P, Kumar, M, Mcnett, M, Naidech, A, Oddo, M, Olson, D, O'Phelan, K, Provencio, J, Puppo, C, Riker, R, Robertson, C, Schmidt, J, and Taccone, F

Subjects
Mean arterial pressure, Critical Care, Intracranial Pressure, Traumatic brain injury, business.industry, musculoskeletal, neural, and ocular physiology, Autoregulation, Cerebral blood flow, Cerebral perfusion pressure, Near-infrared spectroscopy, Pressure reactivity, Transcranial doppler ultrasound, Prognosis, Critical Care and Intensive Care Medicine, medicine.disease, Neurophysiological Monitoring, Cerebral autoregulation, Transcranial Doppler, Cerebral blood flow, Brain Injuries, Cerebrovascular Circulation, Anesthesia, medicine, Homeostasis, Humans, Autoregulation, Neurology (clinical), Cerebral perfusion pressure, business, Intracranial pressure
Abstract

Pressure autoregulation is an important hemodynamic mechanism that protects the brain against inappropriate fluctuations in cerebral blood flow in the face of changing cerebral perfusion pressure (CPP). Static autoregulation represents how far cerebrovascular resistance changes when CPP varies, and dynamic autoregulation represents how fast these changes happen. Both have been monitored in the setting of neurocritical care to aid prognostication and contribute to individualizing CPP targets in patients. Failure of autoregulation is associated with a worse outcome in various acute neurological diseases. Several studies have used transcranial Doppler ultrasound, intracranial pressure (ICP with vascular reactivity as surrogate measure of autoregulation), and near-infrared spectroscopy to continuously monitor the impact of spontaneous fluctuations in CPP on cerebrovascular physiology and to calculate derived variables of autoregulatory efficiency. Many patients who undergo such monitoring demonstrate a range of CPP in which autoregulatory efficiency is optimal. Management of patients at or near this optimal level of CPP is associated with better outcomes in traumatic brain injury. Many of these studies have utilized the concept of the pressure reactivity index, a correlation coefficient between ICP and mean arterial pressure. While further studies are needed, these data suggest that monitoring of autoregulation could aid prognostication and may help identify optimal CPP levels in individual patients.

Published
2014

26. International Multidisciplinary Consensus Conference on Multimodality Monitoring: Cerebral Metabolism

Author

Hutchinson P., O'Phelan K., Le Roux P., Menon D. K., Vespa P., Citerio G., Bader M. K., Brophy G. M., Diringer M. N., Stocchetti N., Videtta W., Armonda R., Badjatia N., Boesel J., Chesnut R., Chou S., Claassen J., Czosnyka M., De Georgia M., Figaji A., Fugate J., Helbok R., Horowitz D., Kumar M., McNett M., Miller C., Naidech A., Oddo M., Olson D., Provencio J., Puppo C., Riker R., Robertson C., Schmidt J. M., Taccone F., Hutchinson, P, O'Phelan, K, Le Roux, P, Menon, D, Vespa, P, Citerio, G, Bader, M, Brophy, G, Diringer, M, Stocchetti, N, Videtta, W, Armonda, R, Badjatia, N, Boesel, J, Chesnut, R, Chou, S, Claassen, J, Czosnyka, M, De Georgia, M, Figaji, A, Fugate, J, Helbok, R, Horowitz, D, Kumar, M, Mcnett, M, Miller, C, Naidech, A, Oddo, M, Olson, D, Provencio, J, Puppo, C, Riker, R, Robertson, C, Schmidt, J, and Taccone, F

Subjects
Microdialysis, medicine.medical_specialty, Subarachnoid hemorrhage, Neurology, Consensus, Critical Care, Traumatic brain injury, Critical Care and Intensive Care Medicine, Multidisciplinary approach, medicine, Humans, Intensive care medicine, Intracerebral hemorrhage, Intention-to-treat analysis, business.industry, Glucose, Glutamate, Intracerebral hemorrhage, Lactate, Lactate pyruvate ratio, Microdialysis, Subarachnoid hemorrhage, Traumatic brain injury, Neurointensive care, Brain, Subarachnoid Hemorrhage, medicine.disease, Neurophysiological Monitoring, Brain Injuries, Neurology (clinical), business, Biomarkers
Abstract

Microdialysis is a powerful technique, which enables the chemistry of the extracellular space to be measured directly. Applying this technique to patients in neurointensive care has increased our understanding of the pathophysiology of traumatic brain injury and spontaneous hemorrhage. In parallel, it is important to determine the place of microdialysis in assisting in the management of patients on an individual intention to treat basis. This is made possible by the availability of analyzers which can measure the concentration of glucose, pyruvate, lactate, and glutamate at the bedside. Samples can then be stored for later analysis of other substrate and metabolites e.g., other amino acids and cytokines. The objective of this paper is to review the fundamental literature pertinent to the clinical application of microdialysis in neurointensive care and to give recommendations on how the technique can be applied to assist in patient management and contribute to outcome. A literature search detected 1,933 publications of which 55 were used for data abstraction and analysis. The role of microdialysis was evaluated in three conditions (traumatic brain injury, subarachnoid hemorrhage, and intracerebral hemorrhage) and recommendations focused on three fundamental areas (relationship to outcome, application of microdialysis to guide therapy, and the ability of microdialysis to predict secondary deterioration).

Published
2014

27. A PROTOCOL TO DEVELOP CLINICAL GUIDELINES FOR INCLUSION-BODY MYOSITIS

Author

Jones, K.L., Sejersen, T., Amato, A.A., Hilton-Jones, D., Schmidt, J., Wallace, A.C., Badrising, U.A., Rose, M.R., and IBM Guideline Dev Grp

Subjects
medicine.medical_specialty, Physiology, diagnosis, Best practice, Myositis, Inclusion Body, IBM, 03 medical and health sciences, Cellular and Molecular Neuroscience, 0302 clinical medicine, Multidisciplinary approach, Physiology (medical), medicine, Humans, 030212 general & internal medicine, guidelines, protocol, Myositis, Protocol (science), Clinical Trials as Topic, business.industry, Issues & Opinions, management, medicine.disease, 3. Good health, Practice Guidelines as Topic, Physical therapy, Etiology, Neurology (clinical), Inclusion body myositis, business, Psychosocial, 030217 neurology & neurosurgery
Abstract

Introduction Inclusion-body myositis (IBM) is a late-onset idiopathic inflammatory myopathy associated with selective and progressive muscle weakness and atrophy. Current clinical management of IBM is largely supportive due to its uncertain etiology and lack of effective treatment. Establishing a consensus of opinion on questions relating to diagnosis and management of IBM is expected to help reduce inconsistencies in the care and resources allocated to those living with this condition. Methods A protocol has been developed to produce best practice clinical guidelines for IBM based on a combination of published research and expert consensus. Conclusions In this study we describe the proposed protocol for developing methods for producing robust and transparent clinical guidance on aspects of diagnosis, drug treatment, physical and practical management, respiration, nutrition and cardiac management, psychosocial management, and multidisciplinary care. Muscle Nerve 53: 503–507, 2016

Published
2016

28. Extended Thromboprophylaxis with Betrixaban in Acutely Ill Medical Patients

Author

Engelbrecht, J., Finfer, S., Van Dyk, C., Cohen, Alexander, Grandes, J., Cepeda, J. M., NAZLIEL, BİJEN, Cohen, Alexander T., Efrati, S., Zakai, N., Yousef, K., Wichman, T., Whitman, B., Welker, J., Welch, M., Warner, A., Updegrove, J., Tuck, M., Stoltz, S., Sokol, S., Sharma, S., Shammas, N., Saba, F., Rodriguez, W., Rees, C., Rastogi, P., Rajan, R., Quintana, O., Pullman, J., Pratt, R., Pineda, L., Pearl, R., Parthiban, K., Overcash, J., Ortel, T., Ohaju, V., Nadar, V., Mittal, M., Milling, T., McLaren, G., Margolis, B., Mahal, S., Macchiavelli, A., Lopez, J., Lerner, R., Kung, M., Kouras, F., Kazimir, M., Kao, C-K., Kabler, H., Ioachimescu, O., Hazelrigg, M., Hamad, A., Haidar, A., Hahn, B., Goytia-Leos, D., Gaggin, H., Fulmer, J., Fraiz, J., Fermann, G., Farley, B., Doshi, A., Dhingra, R., Cornell, J., Concha, M., Clark, C., Chang, H., Carman, T., Bidair, M., Bercz, P., Bastani, A., Barney, J., Baker, S., Anderson, C., Amin, M., Almasri, E., Natarajan, I., McCollum, C., MacCallum, P., Davis, M., Body, R., Yagensky, A., Voronkov, L., Vishnivestsky, I., Vakaliuk, I., Ursol, G., Tseluyko, V., Svyshchenko, Y., Svyridova, I., Ryabichenko, T., Rudenko, L., Alekniene, B., Reshotko, D., Perepeliuk, M., Parkhomenko, O., Nikonov, V., Maslovaskyi, V., Malynovsky, Y., Legkonogov, O., Kyrychenko, I., Krakhmalova, O., Koshlia, V., Kopytsya, M., Karpenko, O., Gryb, V., Goncharova, Y., Goloborodko, B., Goloborodko, A., Godlevska, O., Burmak, I., Brozhyk, J., Batushkin, V., Abrahamovych, O., Tuncay, E., Topcuoglu, M., Tigen, K., Okumus, G., Kutluk, H., Kirma, C., Kilichesmez, K., Guneri, S., Akgul, O., Villalta, J., Vargas Nunez, J. A., Trujillo, J., Riera, A., Richart, C., Mellibovsky, L., Jimenez, D., Gonzales-Porras, J. R., Gomez Cerezo, J., Ferrer, R., Diaz Santos, E., Cereto, F., Castro Guardiola, A., Bisbe, J., Barbagelata Lopez, C., Alvarez Sala, L. A., Mitha, I., Breedt, J., Basson, M., Adler, D., Spisakova, M., Prokop, D., Payer, J., Krastev, G., Kokles, M., Hrubon, A., Herman, O., Dvorak, M., Cervenakova, A., Bodikova, S., Miloradovic, V., Kovacevic-Kuzmanovic, A., Ilic, S., Celic, V., Apostolovic, S., Vishnevskiy, A., Vishneva, E., Solovyov, O., Simanenkov, V., Shvarts, Y., Shpagina, L., Shapovalova, Y., Sergeeva, E., Reshetko, O., Privalova, E., Popov, D., Nilk, R., Nikolaev, K., Mordovin, V., Maslova, N., Martynenko, V., Martynenko, T., Malygin, A., Kostenko, V., Kosmacheva, E., Kobalava, Z., Klein, G., Khachatryan, N., Goloshchekin, B., Ershova, O., Dovgalevskiy, Y., Chefranova, Z., Boldueva, S., Bogdanov, E., Belskaya, G., Barbarash, O., Averkov, O., Arkhipov, M., Apartsin, K., Andreev, D., Abashev, A., Vida-Simiti, L., Stanciulescu, G., Stamate, S., Harrington, Robert A., Goldhaber, Samuel Z., Hull, Russell D., Popescu, M., Wiens, Brian L., Gold, Alex, Hernandez, Adrian F., Gibson, C. Michael, Harrington, Robert, Hull, Russell, Goldhaber, Samuel, Hernandez, Adrian, Ceresetto, Jose Manuel, Colquhoun, David, Pilger, Ernst, Polonetsky, Leonid, Podoleanu, C., Musetescu, R., Marin, I., Bojinca, M., Motte, Serge, Saraiva, Jose Francisco, Balogh, Z. E., Wrzesinski, K., Waldemar, K., Walasek, L., Raev, Dimitar, Mincheva, Valentina, Kahn, Susan, Sulik, P., Canon, Claudia Olivares, Malojcic, Branko, Mayer, Otto, Husted, Steen, Marandi, Toomas, Lassila, Riitta, Mottier, Dominique, Shaburishvili, Tamaz, Bauersachs, Rupert, Zeymer, Uwe, Hajko, Erik, Sobkowicz, B., Zeltser, David, Ageno, Walter, Krievins, Dainis, Bagdonas, Alfredas, Osores, Juan Lema, Tomkowski, Witold, Mot, Stefan, Panchenko, Elizaveta, Tan, Ru San, Gaspar, Ludovit, Jacobson, Barry, Monreal, Manuel, Ongen, Gul, Parkhomenko, Alexander, Uprichard, James, Pulkowski, G., Mirek-Bryniarska, E., Kucharski, L., Jastrzebski, D., Yusen, Roger, Grzelakowski, P., Merli, Geno, Gruenpeter, P., Gorecka, D., Gniot, J., Gaciong, Z., Fryze, W., Peacock, Frank, Schellong, Sebastian, Januzzi, James, Piovella, Franco, Cochet, Madeleine, Michalak, Nathan, Stepanchak, Maria, Spielman, Kathryn, Neal, Brandon, Florea, Ana, Chi, Gerald, Szlosek, Donald, Jain, Purva, Popma, Christopher, Korjian, Serge, Daaboul, Yazan, Halaby, Rim, Yanez, L. Toche, Lemor, Alejandro, Zacarkim, Marcelo, Romero, Gonzalo, Hernandez Elenes, Jesus Rosario, Alvarado, Alonso, Susheela, Ammu, Leitao, Meghan, Salas, M., Bandman, Olga, Horna, M., Strumph, Peter, Vinh, Nancy, Visona, A., Kostadinova, M., Vance, Annemarie, Moia, M., Wiens, Brian, Orlandini, F., Parisi, R., Pontaga, N., Smoak, Carey, Storgaard, M., Molteni, M., Castelino, Rennie, Goodman, Shelly, Stukena, I., Leeds, Janet, al-Khalidi, Hussein, Milanova, M., Karlo, L. Farjardo, Leimberger, Jeffrey, Phillips, Thomas, Rizos, T., Pencheva, G., Pomero, F., Francis, Charles, Novo, S., Pereyra, R. Cotrina, Tiefenbacher, C., Buller, Harry, Roberts, Robin, Prins, Martin, Weimar, C., Tuxen, C., Urhammer, S., Lember, M., Runev, N., Uuetoa, T., Spyropoulos, Alex, Carrier, Marc, Alkonyi, B., Lopes, Renato D., Horacek, T., Airaksinen, J., Honkaniemi, J., Pottier, P., Falukozy, J., Kaaja, R., Stoeva, N., Saarinen, J., Stoyanov, M., Pizzini, A., Devor, Adam, Tatlisumak, T., Kolls, Bradley, Dedrick, Joseph, Todd, Jamie, Jones, William Schuyler, Vikman, S., Agraou, B., Futo, L., Castillo Leon, R., Eapen, Zubin, Katona, A., Proust, A., Quere, I., Kirschner, R., Syulemzova, S., Valavicius, A., Todorov, G., Tokmakova, M., Dhar, A., Klimpe, S., Ahmad, Tariq, Brenna, J. Matthew, Douketis, J., Le Gal, G., Pearce, M., Susinskiene, D., Brito, Flavio, Provencher, S., Rozitis, V., Roy, P-M., Kroning, R., Gulack, Brian, Schmidt, J., Meza, James, Parikh, Kishan, Cooper, Lauren, Poskiene, R., Aquilanti, S., Lapp, H., Kristof, P., Lakatos, F., Laszlo, Z., Belhassane, A., Petrauskiene, R., Pagidipati, Neha, Simoneau, G., Verreault, S., Guimaraes, Patricia, Brisot, D., Perkins, Lynn M., De Geeter, G., Debourdeau, P., Alarcon, M. Arias, Lupkovics, G., Norviliene, R., Wilson, Matthew, Merkely, B., Lazcano, M. Opazo, Collier, Jeannie, Andras, C. Nagy, Cardenas, S. Potthoff, Butkovic-Soldo, S., Norvaisiene, R., Decoulx, E., Hayden, Nikieia, El Kouri, D., Car, S., Nemeth, L., Leizorovicz, Alain, Ciglenecki, N., Naudziunas, A., Datikashvili-David, I., Francetic, I., Jakopovic, M., Becker, Francois, Jennings, Lisa, Khabeishvili, G., Bello, F., Ferrari, A. E., Jure, H., Macin, S., Griskeviciene, V., Kalinic-Grgorinic, H., Falvo, N., Khintibidze, I., Grange, C., Kobulia, B., Knezevic, A., Megreladze, I., Marusic, S., Papp, A., Pagava, Z., Lawall, H., Oliva, M., Paposhvili, K., Parody, M., Amann, B., Soltesz, P., Sudar, Z., Butkiene, Z., Szabo, G., Vagic, J. Sikic, Szegedi, N., Poy, C., Timar, G., Skerk, V., Cermak, O., Valco, J., Baker, R., Coughlin, P., Vertes, A., Rubinfeld, A., Elias, M., Berrouschot, J., Gafter, A., Hayek, T., Chlumsky, J., Lacroix, P., Messas, E., Chochola, J., Cizek, V., Basijokiene, V., Hussein, O., Dunaj, M., Dusek, J., Huber, K., Lishner, M., Lugassy, G., Cerveri, I., D'Angelo, A., De Pellegrin, A., Francek, L., Havelka, J., Konig, J., Beyer-Westendorf, J., Herold, M., Holaj, R., Imberti, D., Landolfi, R., Blessing, E., Mathies, R., Schoenerr, H., Adzerikho, I., Koryk, V., Licka, M., Martinova, V., Horny, I., Mikhailova, E., Mitkovskaya, N., Pimanov, S., Polonetsy, L., Soroka, N., Blockmans, D., Delforge, M., Dive, A., Lienart, F., Bizzacchi, J. Annichino, Fiss, E., Mismetti, P., Freire, A., Hubac, J., Jajtner, P., Manenti, E., Ramacciotti, E., Lembo, G., Raymuno, S., Rocha, A., Kolman, P., Lang, P., Bott, M., Dengler, T., Mikulova, J., Dimov, B., Podpera, I., Reiterer, P., Dziewas, R., Montaclair, K., Genth-Zotz, S., Hamann, F., Paleiron, N., Spacek, R., Payot, L., Vejvoda, J., Vyhnanek, M., Christensen, H., Salvi, A., Lodigiani, C., Pernod, G., Grigorov, M., Lassen, M., Mumoli, N., Kalpachki, R., Kamenova, Z., Schenone, A., Guy's and St Thomas' Hospital [London], Stanford Medicine, Stanford University, Brigham and Women's Hospital [Boston], Thrombosis Research Unit, University of Calgary, Portola Pharmaceuticals (Portola), PORTOLA PHARMACEUTICALS, Division of Cardiology, Duke University Medical Center, Duke Clinical Research Institute (DCRI - DURHAM), Duke University [Durham], Beth Israel Deaconess Medical Center [Boston, USA], Harvard Medical School [Boston] (HMS), Groupe d'Etude de la Thrombose de Bretagne Occidentale (GETBO), Institut Brestois Santé Agro Matière (IBSAM), Université de Brest (UBO)-Université de Brest (UBO)-Université de Brest (UBO), Centre d'Investigation Clinique (CIC - Brest), Université de Brest (UBO)-Institut National de la Santé et de la Recherche Médicale (INSERM), Université de Brest (UBO)-Institut Brestois Santé Agro Matière (IBSAM), and Université de Brest (UBO)-Université de Brest (UBO)

Subjects
Male, Pyridines, Medizin, 030204 cardiovascular system & hematology, law.invention, chemistry.chemical_compound, 0302 clinical medicine, Randomized controlled trial, Risk Factors, law, 030212 general & internal medicine, ComputingMilieux_MISCELLANEOUS, Ultrasonography, Venous Thrombosis, Factors de risc en les malalties, Medicine (all), Acute Disease, Adult, Aged, Benzamides, Double-Blind Method, Drug Administration Schedule, Factor Xa Inhibitors, Female, Fibrin Fibrinogen Degradation Products, Hemorrhage, Hospitalization, Humans, Middle Aged, Pulmonary Embolism, Venous Thromboembolism, General Medicine, 3. Good health, Pulmonary embolism, Venous thrombosis, Cohort, medicine.medical_specialty, Patients, Risk factors in diseases, Placebo, 03 medical and health sciences, [SDV.MHEP.CSC]Life Sciences [q-bio]/Human health and pathology/Cardiology and cardiovascular system, Internal medicine, Thromboembolism, medicine, Pacients, Betrixaban, Thromboprophylaxis, Acutely Ill Medical Patients, Tromboembolisme, business.industry, Settore MED/09 - MEDICINA INTERNA, ta3121, Population cohort, medicine.disease, Surgery, chemistry, Once daily, business
Abstract

Background\ud Patients with acute medical illnesses are at prolonged risk for venous thrombosis. However, the appropriate duration of thromboprophylaxis remains unknown.\ud \ud Methods\ud Patients who were hospitalized for acute medical illnesses were randomly assigned to receive subcutaneous enoxaparin (at a dose of 40 mg once daily) for 10±4 days plus oral betrixaban placebo for 35 to 42 days or subcutaneous enoxaparin placebo for 10±4 days plus oral betrixaban (at a dose of 80 mg once daily) for 35 to 42 days. We performed sequential analyses in three prespecified, progressively inclusive cohorts: patients with an elevated d-dimer level (cohort 1), patients with an elevated d-dimer level or an age of at least 75 years (cohort 2), and all the enrolled patients (overall population cohort). The statistical analysis plan specified that if the between-group difference in any analysis in this sequence was not significant, the other analyses would be considered exploratory. The primary efficacy outcome was a composite of asymptomatic proximal deep-vein thrombosis and symptomatic venous thromboembolism. The principal safety outcome was major bleeding.\ud \ud Results\ud A total of 7513 patients underwent randomization. In cohort 1, the primary efficacy outcome occurred in 6.9% of patients receiving betrixaban and 8.5% receiving enoxaparin (relative risk in the betrixaban group, 0.81; 95% confidence interval [CI], 0.65 to 1.00; P=0.054). The rates were 5.6% and 7.1%, respectively (relative risk, 0.80; 95% CI, 0.66 to 0.98; P=0.03) in cohort 2 and 5.3% and 7.0% (relative risk, 0.76; 95% CI, 0.63 to 0.92; P=0.006) in the overall population. (The last two analyses were considered to be exploratory owing to the result in cohort 1.) In the overall population, major bleeding occurred in 0.7% of the betrixaban group and 0.6% of the enoxaparin group (relative risk, 1.19; 95% CI, 0.67 to 2.12; P=0.55).\ud \ud Conclusions\ud Among acutely ill medical patients with an elevated d-dimer level, there was no significant difference between extended-duration betrixaban and a standard regimen of enoxaparin in the prespecified primary efficacy outcome. However, prespecified exploratory analyses provided evidence suggesting a benefit for betrixaban in the two larger cohorts. (Funded by Portola Pharmaceuticals; APEX ClinicalTrials.gov number, NCT01583218. opens in new tab.)

Published
2016

29. Cardiovascular function is better in veteran football players than age-matched untrained elderly healthy men

Author

Schmidt, J F, Andersen, T R, Andersen, L J, Randers, M B, Hornstrup, T, Hansen, P. R., Bangsbo, J., and Krustrup, P

Subjects
Male, Research Support, Non-U.S. Gov't, Veteran athletes, Cardiovascular System, Ventricular Function, Left, Body Mass Index, Endurance training, Vasodilation, Oxygen Consumption, Adipose Tissue, Peripheral arterial tonometry, Echocardiography, Physical Fitness, Case-Control Studies, Soccer, Body Composition, Journal Article, Humans, Aged
Abstract

The aim of the study was to determine whether lifelong football training may improve cardiovascular function, physical fitness, and body composition. Our subjects were 17 male veteran football players (VPG; 68.1±2.1 years) and 26 healthy age-matched untrained men who served as a control group (CG; 68.2±3.2 years). Examinations included measurements of cardiac function, microvascular endothelial function [reactive hyperemic index (RHI)], maximum oxygen uptake (VO 2 max), and body composition. In VPG, left ventricular (LV) end-diastolic volume was 20% larger (P2 max was higher (18%, P

Published
2015

30. Structural and functional cardiac adaptations to 6 months of football training in untrained hypertensive men

Author

Andersen, L. J., Randers, M. B., Hansen, P. R., Hornstrup, T., Schmidt, J. F., Dvorak, J., Søgaard, P., Krustrup, P., and Bangsbo, J.

Subjects
Adult, Male, Heart Ventricles, Research Support, Non-U.S. Gov't, Blood Pressure Determination, Middle Aged, Ventricular Function, Left, Exercise Therapy, Oxygen Consumption, Treatment Outcome, Ultrasonography, Doppler, Pulsed, Hypertension, Soccer, Randomized Controlled Trial, Exercise Test, Ventricular Function, Right, Journal Article, Humans
Abstract

We investigated the effects of 3 and 6 months of regular football training on cardiac structure and function in hypertensive men. Thirty-one untrained males with mild-to-moderate hypertension were randomized 2:1 to a football training group (n = 20) and a control group receiving traditional recommendations on healthy lifestyle (n = 11). Cardiac measures were evaluated by echocardiography. The football group exhibited significant (P < 0.05) changes in cardiac dimensions and function after just 3 months: Left ventricular (LV) end-diastolic volume increased from 104 ± 25 to 117 ± 29 mL. LV diastolic function improved measured as E/A ratio (1.15 ± 0.32 to 1.54 ± 0.38), early diastolic velocity, E' (11.0 ± 2.5 to 11.9 ± 2.6 cm/s), and isovolumetric relaxation time (74 ± 13 to 62 ± 13 ms). LV systolic function improved measured as longitudinal displacement (10.7 ± 2.1 to 12.1 ± 2.3 mm). Right ventricular function improved with respect to tricuspid annular plane systolic excursion (21.8 ± 3.2 to 24.5 ± 3.7 mm). Arterial blood pressure decreased in both groups, but significantly more in the football training group. No significant changes were observed in the control group. In conclusion, short-term football training improves LV diastolic function in untrained men with mild-to-moderate arterial hypertension. Furthermore, it may improve longitudinal systolic function of both ventricles. The results suggest that football training has favorable effects on cardiac function in hypertensive men.

Published
2014

31. Comparison of fondaparinux with low molecular weight heparin for venous thromboembolism prevention in patients requiring rigid or semi-rigid immobilization for isolated non-surgical below-knee injury

Author

Samama, C. M, Lecoules, N, Kierzek, G, Claessens, Y. E, Riou, B, Rosencher, N, Mismetti, P, Sautet, A, Barrellier, M. -T, Apartsin, K, Jonas, M, Caeiro, J. R, van der Veen, A. H, Roy, P. -M, Accetta, R, Adnet, F, Akhmetova, I, Banihachemi, J. -J, Barbarash, O. L, Barrelier, M. -T, Belentsov, S. M, Bella, S, Benítez, P. C, Bouget, J, Brassart, C, Brem, M, Brule, K, Caeiro Rey, J. R, Caeiro, R, Caimi, M, Castelli, C, Causero, A, Cebrián, A. F, Chabe, C, Cherny, S, Chernyatina, M, Coletta, S. D, Compagnon, A, Couy, C, Crespo, E. C, D'Errico, A. -M, Dahmen, G. P, Deschamps, P, Detomatis, C, Direr, M. -A, Dominguez, S. S, Dupont, P, Ershova, O. B, Faensen, B, Ferrari, S, Ferrata, P, Fleur, F, Fontanel, A, Foronda, I. E, Fort, P. -A, Fragneaud, C, Franchin, F, Franco, M. L, Froehlich, H, Galdo Pérez, J. M, Gauss, H, Gerisch, S, Girard, P, Gottwalles, Y, Haouas, T, Huber, X, Huther, P, Ibán, M. R, Joly, L. -M, Joseph, A, Kazakov, Y, Koehler, J, Koroteev, R, Kort, N. P, Kotelnikov, M. V, Kuropatkin, G, Lablanche, C, Lahne, U, Le Gall, C, Leizorovicz, A, Leluherne, Y, Lenskaya, L, Louis, K, Lozano Moreno, F. J, Maier-Bosse, I, Mairal, O. M, Mallem, A, Manoukian, A, Martos, T. A, Martínez, A. D, Masmoudi, R, Massè, A, Merah, A, Meyer, V, Nachbaur, G, Namir, N, Navarrete, F. G, Olmeda, A, Orinel, E, Pateron, D, Peidró, L, Plechev, V. V, Poissonnet, M, Popov, A, Potel, G, Preusche, A, Quentzel, S, Quilliec, C, Rabier, P, Ramos, M. M, Rebezov, K, Renaud, B, Roca Ruiz, L. J, Ruppe, U, Saliceto, A, Schluender, M, Schmidt, J, Schulz, A. P, Serikova, S, Sevestre, M. -A, Shvalb, P. G, Smirnov, G, Sokurenko, G. Y, Solodovnikov, A, Soroka, V. V, Subbotin, Y, Suplotova, L, Sánchez, M. C, Testroote, M. J. G, Tyuyushev, I, Vasiliev, A, Vasselle, M, Verleisdonk, E. J. M. M, Voss, G, Wallet, E, Weimar, H, Weisslinger, N, Wetzig, L, Yuzko, T, Zafra Jiménez, J. A, Zgura, V, Zhukov, B. N, Zonova, E, Zubareva, N, Zufferey, P, de Fatima Ouedraogo, M, van Haren-Breure, E, van Olden, G. D. J., Service d'anesthésie-réanimation [Hôtel-Dieu], Assistance publique - Hôpitaux de Paris (AP-HP)-Hôpital Hôtel-Dieu [Paris], Service des Urgences ( TOULOUSE - Urgences ), CHU Toulouse [Toulouse], Service des Urgences ( HOTEL DIEU - Urgences ), Assistance publique - Hôpitaux de Paris (AP-HP), Département de Médecine d'Urgence ( MONACO - Urgences ), Princess Grace Hospital Center, Service d'Accueil des Urgences [CHU Pitié-Salpêtrière], CHU Pitié-Salpêtrière [APHP]-Université Pierre et Marie Curie - Paris 6 ( UPMC ) -Assistance publique - Hôpitaux de Paris (AP-HP), Centre d'Investigation Clinique - Epidemiologie Clinique/essais Cliniques Saint Etienne, Université Jean Monnet [Saint-Étienne] ( UJM ) -Institut National de la Santé et de la Recherche Médicale ( INSERM ), Groupe de recherche sur la thrombose ( GRT (EA 3065) ), Université Jean Monnet [Saint-Étienne] ( UJM ), Service de Chirurgie Orthopédique et Traumatologie [CHU Saint-Antoine], CHU Saint-Antoine [APHP]-Assistance publique - Hôpitaux de Paris (AP-HP), Service d'Explorations Fonctionnelles, Hôpital côte de nacre, Scientific Center for Reconstructive and Restorative Surgery ( RUSSIE - IRKUTSK - SCRRS ), Academy of Medical Sciences, Sankt-Joseph Hospital ( Sankt-Joseph Hospital ), Sankt-Joseph Hospital, Department of Orthopedic Surgery ( SANTIAGO - Chir Ortho ), Santiago de Compostela University Hospital, Department of Surgery ( EINDHOVEN - Surgery ), Catharina Hospital, Centre de Recherche Clinique ( CRC Angers ), Université d'Angers ( UA ) -CHU Angers, Service des Urgences ( PMR ), CHRU - ANGERS, Hôpital Hôtel-Dieu [Paris], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP), Service des Urgences (TOULOUSE - Urgences), Service des Urgences (HOTEL DIEU - Urgences), Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP), Département de Médecine d'Urgence (MONACO - Urgences), Université Pierre et Marie Curie - Paris 6 (UPMC)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-CHU Pitié-Salpêtrière [AP-HP], Sorbonne Université (SU)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU), Université Jean Monnet [Saint-Étienne] (UJM)-Institut National de la Santé et de la Recherche Médicale (INSERM), Groupe de recherche sur la thrombose (GRT (EA 3065)), Université Jean Monnet [Saint-Étienne] (UJM), Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-CHU Saint-Antoine [AP-HP], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU)-Sorbonne Université (SU), Service des Explorations Fonctionnelles [CHU Caen], CHU Caen, Normandie Université (NU)-Tumorothèque de Caen Basse-Normandie (TCBN)-Normandie Université (NU)-Tumorothèque de Caen Basse-Normandie (TCBN), Scientific Center for Reconstructive and Restorative Surgery (RUSSIE - IRKUTSK - SCRRS), Sankt-Joseph Hospital (Sankt-Joseph Hospital), Department of Orthopedic Surgery (SANTIAGO - Chir Ortho), Department of Surgery (EINDHOVEN - Surgery), Centre de Recherche Clinique (CRC Angers), Université d'Angers (UA)-Centre Hospitalier Universitaire d'Angers (CHU Angers), PRES Université Nantes Angers Le Mans (UNAM)-PRES Université Nantes Angers Le Mans (UNAM), and Service des Urgences (PMR)

Subjects
Adult, Male, medicine.medical_specialty, medicine.drug_class, Deep vein, [SDV]Life Sciences [q-bio], Low molecular weight heparin, 030204 cardiovascular system & hematology, Fondaparinux, Asymptomatic, 03 medical and health sciences, Immobilization, 0302 clinical medicine, Polysaccharides, medicine, Humans, 030212 general & internal medicine, [ SDV ] Life Sciences [q-bio], Heparin, business.industry, low molecular weight heparin, Low-Molecular-Weight, Anticoagulants, Hematology, Venous Thromboembolism, Bleed, Heparin, Low-Molecular-Weight, bleeding, medicine.disease, Thrombosis, 3. Good health, Pulmonary embolism, Surgery, fondaparinux, lower limb, prophylaxis, trauma, venous thromboembolism, Female, Leg Injuries, medicine.anatomical_structure, Nadroparin, medicine.symptom, business, medicine.drug
Abstract

International audience; BACKGROUND: In several small studies, anticoagulant therapy reduced the incidence of venous thromboembolism (VTE) in patients with isolated lower-limb injuries. OBJECTIVES: To compare the efficacy and safety of fondaparinux 2.5 mg (1.5 mg in patients with a creatinine clearance between 30 and 50 mL min(-1) ) over nadroparin 2850 anti-factor Xa IU. PATIENTS AND METHODS: In this international, multicenter, randomized, open-label study, patients with an isolated non-surgical unilateral below-knee injury having at least one additional major risk factor for VTE and requiring, in the Investigator's opinion, rigid or semi-rigid immobilization for 21-45 days with thromboprophylaxis up to complete mobilization received subcutaneously once-daily either fondaparinux or nadroparin. The primary efficacy outcome was the composite of VTE (symptomatic or ultrasonographically detected asymptomatic deep vein thrombosis of the lower limb or symptomatic pulmonary embolism) and death up to complete mobilization. The main safety outcome was major bleeding. RESULTS: We randomized 1349 patients (mean age 46 years): 88.7% had a bone fracture, and 83.8% had a plaster cast fitted (mean duration of immobilization, 34 days). The primary efficacy outcome occurred in 15 of 584 patients (2.6%) in the fondaparinux group and 48 of 586 patients (8.2%) in the nadroparin group (odds ratio, 0.30; 95% confidence interval [CI], 0.15-0.54; P

Published
2013

32. Oral Apixaban for the Treatment of Acute Venous Thromboembolism

Author

Agnelli, G, Buller, H, Cohen, A, Gallus, A, Raskob, G, Weitz, J, Prins, M, Brandjes, D, Kolbach, D, Limburg, M, Mac Gillavry, M, Otten, Jm, Peters, R, Roos, Y, Segers, A, Slagboom, T, Bounameaux, H, Hirsh, J, Samama, Mm, Wedel, H, Curto, M, Johnson, M, Masiukiewicz, U, Pak, R, Porcari, A, Sanders, P, Sisson, M, Sullivan, B, Thompson, J, Auerbach, J, Cesario, L, Crawford, J, Gordon, M, Noble, M, Pennington, A, Reinhold, P, Simmons, M, Urwin, K, Ceresetto, J, Mcrae, S, Pabinger, I, Pereira, Ah, Spencer, F, Wang, C, Zhang, J, Gorican, K, Husted, Se, Mottier, D, Harenberg, J, Vértes, A, Pinjala, R, Zeltser, D, Prandoni, Paolo, Sandset, M, Torbicki, A, Fijalkowska, A, Alvares, Jp, Kirienko, A, Shvarts, Y, Sala, La, Jacobson, B, Gudz, I, Ortel, T, Spyropoulos, A, Beyer Westendorf, J, Sipos, G, Bredikhin, R, Della Siega, A, Klinke, W, Lawall, H, Zwettler, U, Prasol, V, Cannon, K, Vasylyuk, S, Jin, B, Prandoni, P, Desai, S, Zaichuk, A, Katelnitskiy, I, De Pellegrin, A, Santonastaso, M, Skupyy, O, Pesant, Y, Shvalb, P, Spacek, R, Visonà, A, Alvarez Sala, L, Borja, V, Noori, E, Sereg, M, Braester, A, Falvo, N, Vöhringer, H, Laperna, L, Oliven, A, Skalicka, L, Bolster, D, Haidar, A, Schellong, S, Smith, S, Sergeev, O, Pullman, J, Torp Pedersen, C, Zimlichman, R, Elias, M, Fourie, N, Pernod, G, Panchenko, E, Pendleton, R, van Nieuwenhuizen, E, Vinereanu, D, Becattini, C, Manina, G, Leduc, J, Dunaj, M, Frost, L, Gavish, D, Jakobsen, T, Lishner, M, Morales, L, Chochola, J, Gubka, O, Holaj, R, Hussein, O, Katona, A, Sergeeva, E, Bova, C, Cepeda, J, Cohen, K, Sobkowicz, B, Grzelakowski, P, Husted, S, Lupkovics, G, Dedek, V, Liu, C, Puskas, A, Ritchie, B, Ambrosio, G, Parisi, R, Heuer, H, Livneh, A, Podpera, I, Stanbro, M, Caraco, Y, Fulmer, J, Ghirarduzzi, A, Schmidt Lucke, J, Bergmann, J, Cizek, V, Leyden, M, Stein, R, Abramov, I, Chong, B, Colan, D, Jindal, R, Liu, S, Pereira, A, Porreca, E, Salem, H, Welker, J, Yusen, R, Dhar, A, Podczeck Schweighofer, A, Shtutin, O, Vital Durand, D, Balaji, V, Correa, J, Kline, J, Runyon, M, Laszlo, Z, Martelet, M, Parakh, R, Sandset, Pm, Schmidt, J, Yeo, E, Bhagavan, N, Bura Riviere, A, Ferrer, J, Lacroix, P, Lewczuk, J, Pilger, E, Sokurenko, G, Yu, H, Nikulnikov, P, Pabinger Fasching, I, Sanchez Diaz, C, Schuller, D, Suresh, K, Lobo, S, Lyons, R, Marschang, P, Palla, A, Schulman, S, Spyropoulous, A, Fraiz, J, Gerasymov, V, Lerner, R, Llamas Esperón, G, Manenti, E, Masson, J, Moreira, R, Poy, C, Rodoman, G, Bruckner, I, Gurghean, A, Carrier, M, Freire, A, Gan, E, Gibson, K, Herold, M, Hudcovic, M, Kamath, G, Koslow, A, Meneveau, N, Roos, J, Zahn, R, Balanda, J, Bratsch, H, Dolan, S, Gould, T, Hirschl, M, Hoffmann, U, Kaatz, S, Shah, V, Kadapatti, K, Kræmmer Nielsen, H, Lahav, M, Natarajan, S, Tuxen, C, Tveit, A, Alves, C, Formiga, A, Brudevold, R, Cardozo, M, Lorch, D, Marais, H, Mismetti, P, Panico, M, Pop, C, Quist Paulsen, P, Stevens, D, Tarleton, G, Yoshida, W, Cox, M, Crispin, P, Czekalski, P, Ebrahim, I, Game, M, Ghanima, W, Harrington, D, Jackson, D, Lee, A, Matoska, P, Meade, A, Camargo, Ac, Nishinari, K, Sanchez Llamas, F, Tosetto, A, Vejby Christensen, H, Basson, M, Blombery, P, Fu, G, Jha, V, Keltai, K, Le Jeunne, C, Lodigiani, C, Ma, Y, Nagy, A, Neumeister, A, Shotan, A, Wong, T, Ying, K, Anderson, S, Brenner, B, Carnovali, M, Cerana, S, Cunha, C, Diaz Castañon, J, Graham, M, Kirenko, A, Palareti, G, Rodriguez Cintron, W, Nathanson, A, Rosenthal, S, Sanders, D, Scheinberg, P, Schjesvold, F, Torp, R, van Zyl, L, Venher, I, Xia, G, Brockmyre, A, Chen, Z, Hakki, S, Hanefield, C, Mügge, A, Janczak, D, Karpovych, D, Lancaster, G, Lavigne, C, Lugassy, G, Melaniuk, M, Moran, J, Oliver, M, Schattner, A, Staroverov, I, Timi, J, Vöhringer, F, von Bilderling, P, Warr, T, White, R, Wronski, J, Wu, C, Almeida, C, Blum, A, Bono, J, Durán, M, Erzinger, F, Fu, W, Jagadesan, R, Jurecka, W, Korban, E, Nguyen, D, Raval, M, Willms, D, Zevin, S, Zhu, H, Abdullah, I, Achkar, A, Albuquerque, L, Ali, M, Bai, C, Bloomfield, D, Chen, J, Fajardo Campos, P, Garcia Bragado, F, Kobza, I, Lindhoff Last, E, Lourenço, A, Marchena Yglesias, P, Marshall, P, Siegel, M, Mikhailova, O, Oliva, M, Pottier, P, Pruszczyk, P, Sauer, M, Baloira, A, Cromer, M, D'Angelo, A, Faucher, J, Gutowski, P, Hong, S, Lissauer, M, Lopes, A, Lopes, R, Maholtz, M, Mesquita, E, Miekus, P, Mohan, B, Ng, H, Peterson, M, Piovella, F, Siragusa, S, Srinivas, R, Tiberio, G, Van Bellen, B, Arutyunov, G, Assi, N, Baker, R, Blanc, F, Curnow, J, Fu, C, Gonzalez Porras, J, Guijarro Merino, R, Gunasingam, S, Gupta, P, Laule, M, Liu, Z, Luber, J, Serifilippi, G, Paulson, R, Shevela, A, Simonneau, G, Siu, D, Sosa Liprandi, M, Takács, J, Tay, J, Vora, K, Witkiewicz, W, Zhao, L, Aquilanti, S, Dabbagh, O, Dellas, C, Denaro, C, Doshi, A, Flippo, G, Giumelli, C, Gomez Cerezo, J, Han, D, Harris, L, Hofmann L., Jr, Kamerkar, D, Kaminski, L, Kazimir, M, Kloczko, J, Ko, Y, Koura, F, Lavender, R, Maly, J, Margolis, B, Mos, L, Sanchez Escalante, L, Solvang, A, Soroka, V, Szopinski, P, Thawani, H, Vickars, L, Yip, G, Zangroniz, P., Internal and Cardiovascular Medicine - Stroke Unit (PERUGIA - ICM-SU), Università degli Studi di Perugia (UNIPG), Department of Vascular Medicine (DVM - AMC), Academic Medical Center - Academisch Medisch Centrum [Amsterdam] (AMC), University of Amsterdam [Amsterdam] (UvA)-University of Amsterdam [Amsterdam] (UvA), King's College Hospital (KCH), Department of Haematology (ADELAIDE - Dep Haemato), Flinders Medical Centre-Flinders University, Health Sciences Center (OKLAHOMA - HSC), University of Oklahoma (OU), Thrombosis and Atherosclerosis Research Institute (TARI), McMaster University [Hamilton, Ontario], Centre d'Investigation Clinique (CIC - Brest), Université de Brest (UBO)-Institut National de la Santé et de la Recherche Médicale (INSERM), Groupe d'Etude de la Thrombose de Bretagne Occidentale (GETBO), Université de Brest (UBO)-Institut Brestois Santé Agro Matière (IBSAM), Université de Brest (UBO)-Université de Brest (UBO), ACS - Amsterdam Cardiovascular Sciences, Vascular Medicine, APH - Amsterdam Public Health, Cardiology, ANS - Amsterdam Neuroscience, Neurology, and Other departments

Subjects
Male, MESH: Factor Xa, [SDV]Life Sciences [q-bio], Administration, Oral, Kaplan-Meier Estimate, 030204 cardiovascular system & hematology, THERAPY, MESH: Venous Thromboembolism, chemistry.chemical_compound, 0302 clinical medicine, Edoxaban, MESH: Double-Blind Method, 030212 general & internal medicine, MESH: Warfarin, MESH: Treatment Outcome, MESH: Aged, RISK, MESH: Middle Aged, General Medicine, MESH: Follow-Up Studies, Venous Thromboembolism, Middle Aged, 3. Good health, Pulmonary embolism, Treatment Outcome, MESH: Administration, Oral, Acute Disease, MESH: Acute Disease, Apixaban, Female, MESH: Hemorrhage, medicine.drug, Andexanet alfa, Adult, medicine.medical_specialty, MESH: Enoxaparin, Pyridones, PULMONARY-EMBOLISM, Hemorrhage, MESH: Anticoagulants, 03 medical and health sciences, Double-Blind Method, BINOMIAL TRIALS, Internal medicine, MESH: Pyridones, medicine, Humans, Enoxaparin, MESH: Kaplan-Meier Estimate, RIVAROXABAN, Aged, Rivaroxaban, MESH: Humans, business.industry, Warfarin, Anticoagulants, MESH: Adult, medicine.disease, Confidence interval, MESH: Male, Surgery, chemistry, Relative risk, Pyrazoles, business, MESH: Female, MESH: Pyrazoles, Factor Xa Inhibitors, Follow-Up Studies
Abstract

International audience; BACKGROUND: Apixaban, an oral factor Xa inhibitor administered in fixed doses, may simplify the treatment of venous thromboembolism. METHODS: In this randomized, double-blind study, we compared apixaban (at a dose of 10 mg twice daily for 7 days, followed by 5 mg twice daily for 6 months) with conventional therapy (subcutaneous enoxaparin, followed by warfarin) in 5395 patients with acute venous thromboembolism. The primary efficacy outcome was recurrent symptomatic venous thromboembolism or death related to venous thromboembolism. The principal safety outcomes were major bleeding alone and major bleeding plus clinically relevant nonmajor bleeding. RESULTS: The primary efficacy outcome occurred in 59 of 2609 patients (2.3%) in the apixaban group, as compared with 71 of 2635 (2.7%) in the conventional-therapy group (relative risk, 0.84; 95% confidence interval [CI], 0.60 to 1.18; difference in risk [apixaban minus conventional therapy], -0.4 percentage points; 95% CI, -1.3 to 0.4). Apixaban was noninferior to conventional therapy (P

Published
2013

33. Classification of acute pancreatitis--2012: revision of the Atlanta classification and definitions by international consensus

Author

Acosta, Jm, Amann, St, Andren Sandberg, A, Aranha, Gv, Asciutti, S, Banks, Pa, Barauskas, G, Baron, Th, Bassi, Claudio, Behrman, S, Behms, Ke, Belliappa, V, Berzin, Tm, Besselink, Mg, Bhasin, Dk, Biankin, A, Bishop, Md, Bollen, Tl, Bonini, Cj, Bradley, El, Buechler, M, Carter, Michael Ross, Cavestro, Gm, Chari, St, Chavez Rodriguez, Jj, da Cunha, Je, D'Agostino, H, De Campos, T, Delakidis, S, de Madaria, E, Deprez, Ph, Dervenis, C, Disario, Ja, Doria, C, Falconi, Massimo, Fernandez del Castillo, C, Freeny, Pc, Frey, Cf, Friess, H, Frossard, Jl, Fuchshuber, P, Gallagher, Sf, Gardner, Tb, Garg, Pk, Ghattas, G, Glasgow, R, Gonzalez, Ja, Gooszen, Hg, Gress, Tm, Gumbs, Aa, Halliburton, C, Helton, S, Hill, Mc, Horvath, Kd, Hoyos, S, Imrie, Cw, Isenmann, R, Izbicki, Jr, Johnson, Cd, Karagiannis, Ja, Klar, E, Kolokythas, O, Lau, J, Litvin, Aa, Longnecker, Ds, Lowenfels, Ab, Mackey, R, Mah'Moud, M, Malangoni, M, Mcfadden, Dw, Mishra, G, Moody, Fg, Morgan, De, Morinville, V, Mortele, Kj, Neoptolemos, Jp, Nordback, I, Pap, A, Papachristou, Gi, Parks, R, Pedrazolli, S, Pelaez Luna, M, Pezzilli, R, Pitt, Ha, Prosanto, C, Ramesh, H, Ramirez, Fc, Raper, Se, Rasheed, A, Reed, Dn, Romangnuolo, J, Rossaak, J, Sanabria, J, Sarr, Mg, Schaefer, C, Schmidt, J, Schmidt, Pn, Serrablo, A, Senkowski, Ck, Sharma, M, Sigman, Km, Singh, P, Stefanidis, G, Steinberg, W, Steiner, J, Strasberg, S, Strum, W, Takada, T, Tanaka, M, Thoeni, Rf, Tsiotos, Gg, Van Santvoort, H, Vaccaro, M, Vege, Ss, Villavicencio, Rl, Vrochides, D, Wagner, M, Warshaw, Al, Wilcox, Cm, Windsor, Ja, Wysocki, P, Yadav, D, Zenilman, Me, Zyromski, N. j., Banks, P, Bollen, T, Dervenis, C, Gooszen, H, Johnson, C, Sarr, M, Tsiotos, G, Vege, S, Cavestro, GIULIA MARTINA, and ACUTE PANCREATITIS CLASSIFICATION WORKING, Group

Subjects
Clinical deffinitions, medicine.medical_specialty, CIENCIAS MÉDICAS Y DE LA SALUD, Exacerbation, MEDLINE, Medicina Clínica, Disease, Guideline, Severity of Illness Index, Atlanta classification, Cystogastrostomy, purl.org/becyt/ford/3.2 [https], Severity of illness, medicine, Humans, Acute Disease, Disease Progression, Pancreatitis, Tomography, X-Ray Computed, Ranson criteria, Intensive care medicine, Tomography, business.industry, Gastroenterology, medicine.disease, Acute pancreatitis, X-Ray Computed, Surgery, Evaluation of complex medical interventions [NCEBP 2], purl.org/becyt/ford/3 [https], Medicina Critica y de Emergencia, business
Abstract

Background and objective: The Atlanta classification of acute pancreatitis enabled standardised reporting of research and aided communication between clinicians. Deficiencies identified and improved understanding of the disease make a revision necessary. Methods: A web-based consultation was undertaken in 2007 to ensure wide participation of pancreatologists. After an initial meeting, the Working Group sent a draft document to 11 national and international pancreatic associations. This working draft was forwarded to all members. Revisions were made in response to comments, and the web-based consultation was repeated three times. The final consensus was reviewed, and only statements based on published evidence were retained. Results: The revised classification of acute pancreatitis identified two phases of the disease: early and late. Severity is classified as mild, moderate or severe. Mild acute pancreatitis, the most common form, has no organ failure, local or systemic complications and usually resolves in the first week. Moderately severe acute pancreatitis is defined by the presence of transient organ failure, local complications or exacerbation of co-morbid disease. Severe acute pancreatitis is defined by persistent organ failure, that is, organ failure >48 h. Local complications are peripancreatic fluid collections, pancreatic and peripancreatic necrosis (sterile or infected), pseudocyst and walled-off necrosis (sterile or infected). We present a standardised template for reporting CT images. Conclusions: This international, web-based consensus provides clear definitions to classify acute pancreatitis using easily identified clinical and radiologic criteria. The wide consultation among pancreatologists to reach this consensus should encourage widespread adoption. Fil: Banks, Peter A.. Harvard Medical School; Estados Unidos Fil: Bollen, Thomas L.. St Antonius Hospital; Países Bajos Fil: Dervenis, Christos. Agia Olga Hospital; Grecia Fil: Gooszen, Hein G.. Radboud Universiteit Nijmegen; Países Bajos Fil: Johnson, Colin D.. University Hospital Southampton; Reino Unido Fil: Sarr, Michael G.. Mayo Clinic; Estados Unidos Fil: Tsiotos, Gregory G.. Metropolitan Hospital; Grecia Fil: Vege, Santhi Swaroop. Metropolitan Hospital; Grecia Fil: Vaccaro, Maria Ines. Consejo Nacional de Investigaciones Científicas y Técnicas; Argentina Fil: Acute Pancreatitis Classification Working Group. No especifica

Published
2013

34. Apixaban for extended treatment of venous thromboembolism

Author

Agnelli, G, Buller, H, Cohen, A, Gallus, A, Raskob, G, Weitz, J, Prins, M, Brandjes, D, Kolbach, D, Limburg, M, Mac Gillavry, M, Otten, Jm, Peters, R, Roos, Y, Segers, A, Slagboom, T, Bounameaux, H, Hirsh, J, Samama, Mm, Wedel, H, Curto, M, Johnson, M, Masiukiewicz, U, Pak, R, Porcari, A, Sanders, P, Sisson, M, Sullivan, B, Thompson, J, Auerbach, J, Cesario, L, Gamero, M, Gordon, M, Griffiths, A, Noble, M, Ott, J, Pennington, A, Peffer, A, Reinhold, P, Simmons, M, Urwin, K, Ceresetto, J, Mcrae, S, Pabinger, I, Pereira, Ah, Spencer, F, Gorican, K, Husted, Se, Mottier, D, Harenberg, J, Pinjala, R, Zeltser, D, Imberti, D, Sandset, M, Torbicki, A, Fijalkowska, A, Albino, Jp, Kirienko, A, Shvarts, Y, Monreal, M, Jacobson, B, Dolan, G, Gudz, I, Ortel, T, Spyropoulos, A, Skupyy, O, Beryer Westendorf, J, De Pellegrin, A, Prasol, V, Schellong, S, Falvo, N, Abramov, I, Cizek, V, Husted, S, Desai, S, Barillari, G, Sergeev, O, Chetter, I, Inbal, A, Mccollum, C, Shvalb, P, Torp Pedersen, C, Vasylyuk, S, Kraemmer Nielsen, H, Pernod, G, Schmidt, J, Bova, C, Gerasymov, V, Pabinger Fasching, I, Skalicka, L, Zaichuk, A, Achkar, A, Bremmelgaard, A, Chochola, J, Gould, T, Khalafallah, A, Jakobsen, T, Rose, P, Zhukov, B, Dedek, V, Mirete Ferrer, J, Pesant, Y, Repin, A, Salem, H, Solis Morales, L, Spacek, R, Cannon, K, Grzelakowski, P, Jindal, R, Pereira, A, Zidkova, E, Ambrosio, G, Cardozo, M, Dunaj, M, Gavish, D, Ghanima, W, Leduc, Jj, Mismetti, P, Panico, M, Porreca, E, Riera, A, Bareford, D, Chong, B, Dvoryashina, I, Gómez Cerezo, J, Kobza, I, Nielsen, T, Pendleton, R, Pullman, J, Schiffman, G, Stanbro, M, Zwettler, U, Aquilanti, S, Bratsch, H, Cohen, K, Elias, D, Gan, E, Holaj, R, Klinke, W, Liu, Hs, Sandset, Pm, van Nieuwenhuizen, E, Álvarez Sala LA, Basson, M, Braester, A, Bura Riviere, A, Calvo Vargas, C, Correa, J, Elias, M, Frost, L, Landolfi, R, Marschang, P, Moreira, R, Natarajan, S, Pottier, P, Tosetto, A, Tuxen, C, Vöhringer, Hf, Alexander, A, Barbarash, O, Fajardo Campos, P, Graham, M, Gubka, O, Hudcovic, M, Hussein, O, Jackson, D, Katelnitskiy, I, Lawall, H, Palareti, G, Poggio, R, Roos, J, Simonneau, G, Smith, Sw, Szopinski, P, Zimlichman, R, Bridgers, D, Colan, D, Czekalski, P, De Jong, D, Fortinez, Jt, Garcia Bragado, F, Harrington, D, Izbicki, G, Kadr, H, Koslow, A, Loftus, I, Marais, H, Neumeister, A, Oliven, A, Palla, A, Pop, C, Prandoni, Paolo, Puskas, A, Sanchez Llamas, F, Shotan, A, Singh, P, Tveit, A, Baker, R, Borja, V, Brenner, B, Brown, H, Cha, Tj, Cohen, Y, D'Angelo, A, Dhar, A, Friis, E, Hueur, H, Jiménez Rodríguez Madridejos, R, Karl, J, Karrasch, J, Lishner, M, Manenti, E, Meneveau, N, Nguyen, D, Sanchez Escalante, L, Santoscoy Ibarra, J, Sokurenko, G, Staroverov, I, Stein, R, Abdullah, I, Alcocer Gamba, M, Balanda, J, Bruckner, I, Calabuig Alborch, J, Caraco, Y, Comerota, A, Cromer, M, de Araujo Filho, J, De los Rios Ibarra, M, Diaz Castañon, J, Doshi, A, Ebrahim, I, Fessel, Wj, Fletcher, E, Fourie, N, Fu, C, Gutowski, P, Haddad, G, Hoffman, U, Jardula, M, Kvasnicka, T, Lewczuk, J, Leyden, M, Livneh, A, Lodigiani, C, Lovell, C, Miekus, P, Paloma, Mj, Parakh, R, Raval, M, Schmidt Lucke, J, Shtutin, O, Soroka, V, Stevens, D, Sulik, P, Tay, Jc, Vejby Christensen, H, Vinereanu, D, Baghestanian, M, Bono, J, Cerana, S, Freire, A, Gibson, K, Giumelli, C, Iastrebner, C, Karpenko, A, Kelly, A, Lacroix, P, Lafata, J, Lobo, S, Macik, Bg, Marchena Yglesias, P, Nishinari, K, Podczeck Schweighofer, A, Raby, K, Sirpal, S, Solymoss, S, van Zyl, L, Vargas Núñez JA, von Bilderling, P, Warr, T, Wronski, J, Wurster, M, Albino, Ja, Albuquerque, L, Averill, F, Baek, Sh, Bello, F, Bergoeing, M, Blanc, Fx, Bloomberg, R, Bolster, D, Brockmyre, A, Calimano, C, Checketts, D, Cieplinski, W, Chervu, A, Collado, F, Denaro, C, Gaciong, Z, Game, M, Iskander, A, Kaatz, S, Kim, Di, Koura, F, Laguna, F, Lanas Zanetti, F, Lindhoff Last, E, Melaniuk, M, Meade, A, Murphy, T, Ng, Hj, Páramo Fernández JA, Patil, C, Piovella, F, Prisco, D, Pruszczyk, P, Reimers, G, Rivera, E, Rodriguez Cintron, W, Rosenthal, S, Salbach, P, Salvador, D, Schuller, D, Siragusa, S, Staniszewski, R, Torp, R, Vora, K, Yip, G, Alfieri, A, Belaji, V, Bhagavan, N, Carnovali, M, Cobos Segarra, J, Di Todaro, F, Dowell, A, Corder, C, Crispin, P, Cuadrado, J, Flippo, G, Fraiz, J, Guillaumon, A, Gvora, T, Hakki, S, Harris, L, Ison, R, Htun, Pt, Jasani, R, Kates, M, Kaminski, L, Kamerkar, D, Kroger, K, Laperna, L, Leiva, J, Luber, J, Mccann, A, Mckenzie, W, Menna Barreto, S, Moran, J, Nikulnikov, P, Paliwal, Y, Patel, M, Pilger, E, Renwick, W, Shevela, A, Starosiliz, D, Stringam, S, To, R, Updegrove, J, Van Bellen, B, Waintrub, M, White, J, Yeo, E, Zangroniz, P, Zeltser, D., ACS - Amsterdam Cardiovascular Sciences, Vascular Medicine, APH - Amsterdam Public Health, Cardiology, ANS - Amsterdam Neuroscience, Neurology, Department of Vascular Medicine (DVM - AMC), Academic Medical Center - Academisch Medisch Centrum [Amsterdam] (AMC), University of Amsterdam [Amsterdam] (UvA)-University of Amsterdam [Amsterdam] (UvA), Thrombosis and Atherosclerosis Research Institute (TARI), McMaster University [Hamilton, Ontario], Centre d'Investigation Clinique (CIC - Brest), Université de Brest (UBO)-Institut National de la Santé et de la Recherche Médicale (INSERM), Groupe d'Etude de la Thrombose de Bretagne Occidentale (GETBO), Université de Brest (UBO)-Institut Brestois Santé Agro Matière (IBSAM), and Université de Brest (UBO)-Université de Brest (UBO)

Subjects
Male, Kaplan-Meier Estimate, 030204 cardiovascular system & hematology, Placebo group, DISEASE, law.invention, 0302 clinical medicine, Randomized controlled trial, law, Recurrence, Fibrinolytic agents, 030212 general & internal medicine, IDRAPARINUX, Administration of drugs, Follow up studies, food and beverages, General Medicine, Venous Thromboembolism, Middle Aged, 3. Good health, Intention to Treat Analysis, Treatment Outcome, Treatment dose, Anesthesia, Creatinine, Factor Xa, Fibrinolítics, Apixaban, Female, Administració de medicaments, Major bleeding, medicine.drug, ARTERIAL CARDIOVASCULAR EVENTS, INTENSITY WARFARIN THERAPY, PULMONARY-EMBOLISM, LONG-TERM, PREVENTION, Adult, Pyridones, Hemorrhage, 03 medical and health sciences, Double-Blind Method, Fibrinolytic Agents, Thromboembolism, medicine, Humans, Tromboembolisme, Aged, Intention-to-treat analysis, business.industry, fungi, Pyrazoles, business, Venous thromboembolism, [SDV.MHEP]Life Sciences [q-bio]/Human health and pathology, Factor Xa Inhibitors, Follow-Up Studies
Abstract

International audience; Background Apixaban, an oral factor Xa inhibitor that can be administered in a simple, fixed-dose regimen, may be an option for the extended treatment of venous thromboembolism. Methods In this randomized, double-blind study, we compared two doses of apixaban (2.5 mg and 5 mg, twice daily) with placebo in patients with venous thromboembolism who had completed 6 to 12 months of anticoagulation therapy and for whom there was clinical equipoise regarding the continuation or cessation of anticoagulation therapy. The study drugs were administered for 12 months. Results A total of 2486 patients underwent randomization, of whom 2482 were included in the intention-to-treat analyses. Symptomatic recurrent venous thromboembolism or death from venous thromboembolism occurred in 73 of the 829 patients (8.8%) who were receiving placebo, as compared with 14 of the 840 patients (1.7%) who were receiving 2.5 mg of apixaban (a difference of 7.2 percentage points; 95% confidence interval [CI], 5.0 to 9.3) and 14 of the 813 patients (1.7%) who were receiving 5 mg of apixaban (a difference of 7.0 percentage points; 95% CI, 4.9 to 9.1) (P

Published
2012

35. Oral Rivaroxaban for the Treatment of Symptomatic Pulmonary Embolism

Author

Agnelli, G, Berkowitz, S, Bounameaux, H, Büller, Hr, Cohen, A, Gallus, A, Lensing, Aw, Misselwitz, F, Haskell, L, Prins, Mh, Raskob, G, Schellong, S, Bauersachs, R, van Bellen, B, Boda, Z, Borris, L, Brenner, B, Brighton, T, Chlumsky, J, Davidson, B, Decousus, H, Eriksson, H, Jacobson, B, Kakkar, A, Kwong, Yl, Lee, Lh, Meijer, K, van der Meer, J, Minar, E, Monreal, M, Piovella, F, Sandset, Pm, Smith, M, Tomkowski, W, Verhamme, P, Wang, Y, Wells, P, Brandjes, D, Mac Gillavry, M, Otten, Hm, Carlsson, A, Laporte, S, Schulman, S, Gent, M, Turpie, A, Martinelli, I, Segers, A, Muhlhofer, E, Tewes, M, Trajanovic, M, Muller, K, Kim, C, Gebel, M, Benson, A, Pap, Af, Godrie, J, Horvat Broecker, A, Spadari, G, Peters Wulf, C, Roig, J, Baker, R, Bianchi, A, Blombery, P, Campbell, P, Carroll, P, Geraghty, R, Chong, B, Ramanathan, S, Archis, C, Coughlin, P, Salem, H, Crispin, P, Dean, M, Soni, R, Denaro, C, Kubler, P, Coghlan, D, Gan, Te, Tran, H, Coleman, C, Jackson, D, Khalafallah, A, Leahy, M, Leyden, M, Leyden, D, Sturtz, C, Mccann, A, Gibbs, H, Mcrae, S, Richards, B, Ward, C, Curnow, J, Baghestanian, M, Erdogmus, B, Samaha, E, Nikoupayan Mofrad, M, Hirschl, M, Sturm, W, Kirchmair, R, Marschang, P, Drexel, H, Mathies, R, Pilger, E, Brodmann, M, Weltermann, A, Buche, M, Demelenne, J, Gustin, M, Hainaut, P, Pothen, L, de Leersnyder, J, Motte, S, Schroë, H, Sprynger, M, Peerlinck, K, Delcroix, M, Vermassen, F, Verstraeten, P, Smet, V, Vossaert, R, Panico, M, Costa, C, Blondal, J, Kovacs, M, Rodger, M, Carrier, M, Wong, T, Bi, J, Chen, Z, Chen, R, Jing, Zc, He, J, Liu, C, Liu, S, Long, S, Ma, Y, Shao, Y, Wang, C, Yang, Yh, Xie, C, Xu, J, Ying, K, Zhihong, L, Hola, D, Jirat, S, Vitovec, M, Kovářová, K, Gilík, J, Dosál, J, Mandakova, E, Matoška, P, Podpera, I, Podperova, M, Spacek, R, Urbanova, R, Tuxen, C, Sukles, K, Pietila, K, Vesanen, M, Achkar, A, Agraou, B, Aquilanti, S, Rifaï, A, Berremili, T, Brisot, D, Brousse, C, Tarodo, P, Bura, A, Amid Lacombe, C, Malloizel, J, Boulon, C, Alavoine, L, Crestani, B, Mismetti, P, Buchmuller, A, Accassat, S, Elias, A, Elias, M, Emmerich, J, Ferrari, E, Guérin, T, Beaka, P, Lacroix, P, Szwebel, Ta, Benhamou, Y, de Maistre, E, Falvo, N, Mahe, I, Meneveau, N, Schiele, F, Meyer, G, Sanchez, O, Planquette, B, Mottier, D, Le Moigne, E, Couturaud, F, Parent, F, Pernod, G, Imbert, B, Elkouri, D, Dary, M, Queguiner, A, Quere, I, Galanaud, Jp, Roy, Pm, de Boisjolly Bonnefoi JM, Schmidt, J, Breuil, N, Heuser, S, Sevestre, Ma, Simoneau, G, Bergmann, Jf, Stephan, D, Trinh Duc, A, Gaillardou, A, Grange, C, Fassier, T, Wahl, D, Baron Von Bilderling, P, Kuhlencordt, P, Beyer Westendorf, J, Halbritter, K, Werth, S, Diehm, C, Lawall, H, Eifrig, B, Espinola Klein, C, Weisser, G, Giannitsis, E, Haering, Hu, Hasslacher, C, Herrmann, T, Hoffmann, U, Czihal, M, Horacek, T, Ibe, M, Bauer, A, Kieback, A, Landgraf, H, Lindhoff Last, E, Malyar, N, Petermann, W, Potratz, J, Ranft, J, Röcken, M, Pomper, L, Frommhold, R, Schwaiblmair, M, Berghaus, T, Taute, B, Lau, Yk, Tse, E, Olah, Z, Farkas, K, Kolossváry, E, Gurzó, M, Kis, E, Kovács, A, Landi, A, Lupkovics, G, Pecsvarady, Z, Riba, M, Sipos, G, Parakh, R, Sembiring, R, Barton, J, Goldstein, L, Gavish, D, Hoffman, R, Hussein, O, Inbal, A, Lishner, M, Elis, A, Lugassy, G, Varon, D, Zeltser, D, Rogowski, O, Steinvil, A, Zisman, D, Ageno, W, Ambrosio, G, Cattaneo, M, D'Angelo, A, Ghirarduzzi, A, Lotti, M, Pierfranceschi, Mg, Lodigiani, C, Palareti, G, Barone, M, Beltrametti, C, Porreca, E, Prandoni, Paolo, Spiezia, L, Quintavalla, R, Cho, Wh, Ha, Jw, Kim, Hs, Park, K, Sime, I, Miliauskas, S, Petrauskiene, R, Sathar, J, Beeker, A, Ten Cate, H, De Groot, M, Kamphuisen, P, Douma, R, Kooy, Mv, Coenen, J, Mäkelburg, A, Knol, M, Tichelaar, V, Harper, P, Knottenbelt, E, Ockelford, P, Young, L, Royle, G, Simpson, D, Chunilal, S, Ghanima, W, Foyn, S, Tveit, A, Abola, Mt, Adamiec, R, Gorski, P, Kloczko, J, Lewczuk, J, Nowak, M, Musial, J, Wronski, J, Ng, Hj, Adler, D, Becker, Jh, Ellis, G, Isaacs, R, Bloy, B, Allie, R, Eckstein, F, van Rensburg JH, Schmidt, S, Siebert, H, Zyl, L, Carrera, M, Del Campo, F, Diego, I, Garcia Bragado, F, Jiménez, D, Sánchez Álvarez, J, Redondo, M, Roman Sanchez, P, Villalta, J, Villegas Scivetti, M, Jonson, T, Tygesen, H, Lapidus, L, Ottosson, E, Själander, A, Asmis, L, Banyai, M, Heidemann, M, Baumgartner, I, Righini, M, Frank, U, Hayoz, D, Periard, D, Chang, Wt, Chiu, K, Wang, Ky, Weng, Zc, Angchaisuksiri, P, Pothirat, C, Rojnuckarin, P, Solis, J, Hunt, B, Luckit, J, Albrecht, C, Banish, D, Feinbloom, D, Botnick, W, Chen, D, Dexter, J, Ettinger, N, Gleeson, J, Jaffer, A, Joseph, S, Kennedy, M, Krell, K, Lavender, R, Lyons, R, Moll, S, Nadar, V, Darrow, K, Hardman, V, Rathbun, S, Rehm, J, Rodriguez Cintron, W, Stevens, K, Wright, P, Ramaswamy, M., ACS - Amsterdam Cardiovascular Sciences, Vascular Medicine, Other departments, Epidemiologie, MUMC+: KIO Kemta (9), RS: CAPHRI School for Public Health and Primary Care, Department of Vascular Medicine (DVM - AMC), Academic Medical Center - Academisch Medisch Centrum [Amsterdam] (AMC), University of Amsterdam [Amsterdam] (UvA)-University of Amsterdam [Amsterdam] (UvA), Department of Epidemiology (MHP), Maastricht University [Maastricht], Groupe de recherche sur la thrombose (GRT (EA 3065)), Université Jean Monnet [Saint-Étienne] (UJM), Service d'angiologie et d'hémostase (MR), Hôpital Universitaire de Genève, Groupe d'Etude de la Thrombose de Bretagne Occidentale (GETBO), Université de Brest (UBO)-Institut Brestois Santé Agro Matière (IBSAM), Université de Brest (UBO)-Université de Brest (UBO), Centre d'Investigation Clinique (CIC - Brest), and Université de Brest (UBO)-Institut National de la Santé et de la Recherche Médicale (INSERM)

Subjects
MESH: Pulmonary Embolism, Male, Vitamin K, Administration, Oral, Pulmonary Embolism/drug therapy/mortality, Kaplan-Meier Estimate, 030204 cardiovascular system & hematology, chemistry.chemical_compound, 0302 clinical medicine, Rivaroxaban, Edoxaban, Recurrence, Hemorrhage/chemically induced, 030212 general & internal medicine, Vitamin K/antagonists & inhibitors, Enoxaparin/adverse effects/therapeutic use, MESH: Treatment Outcome, MESH: Aged, ddc:616, MESH: Middle Aged, Hazard ratio, General Medicine, MESH: Follow-Up Studies, Vitamin K antagonist, MESH: Thiophenes, Middle Aged, Thrombosis, Morpholines/adverse effects/therapeutic use, 3. Good health, Pulmonary embolism, MESH: International Normalized Ratio, Treatment Outcome, Anesthesia, MESH: Administration, Oral, Administration, Combination, Apixaban, Drug Therapy, Combination, Female, MESH: Hemorrhage, medicine.drug, Oral, MESH: Enoxaparin, medicine.drug_class, Morpholines, Anticoagulants/adverse effects/therapeutic use, MESH: Morpholines, Hemorrhage, Thiophenes, MESH: Anticoagulants, 03 medical and health sciences, Drug Therapy, medicine, Humans, International Normalized Ratio, Enoxaparin, MESH: Kaplan-Meier Estimate, Aged, MESH: Humans, business.industry, MESH: Vitamin K, Anticoagulants, medicine.disease, MESH: Male, MESH: Recurrence, Regimen, MESH: Drug Therapy, Combination, chemistry, Thiophenes/adverse effects/therapeutic use, business, Pulmonary Embolism, MESH: Female, [SDV.MHEP]Life Sciences [q-bio]/Human health and pathology, Follow-Up Studies
Abstract

International audience; BACKGROUND: A fixed-dose regimen of rivaroxaban, an oral factor Xa inhibitor, has been shown to be as effective as standard anticoagulant therapy for the treatment of deep-vein thrombosis, without the need for laboratory monitoring. This approach may also simplify the treatment of pulmonary embolism. METHODS: In a randomized, open-label, event-driven, noninferiority trial involving 4832 patients who had acute symptomatic pulmonary embolism with or without deep-vein thrombosis, we compared rivaroxaban (15 mg twice daily for 3 weeks, followed by 20 mg once daily) with standard therapy with enoxaparin followed by an adjusted-dose vitamin K antagonist for 3, 6, or 12 months. The primary efficacy outcome was symptomatic recurrent venous thromboembolism. The principal safety outcome was major or clinically relevant nonmajor bleeding. RESULTS: Rivaroxaban was noninferior to standard therapy (noninferiority margin, 2.0; P=0.003) for the primary efficacy outcome, with 50 events in the rivaroxaban group (2.1%) versus 44 events in the standard-therapy group (1.8%) (hazard ratio, 1.12; 95% confidence interval [CI], 0.75 to 1.68). The principal safety outcome occurred in 10.3% of patients in the rivaroxaban group and 11.4% of those in the standard-therapy group (hazard ratio, 0.90; 95% CI, 0.76 to 1.07; P=0.23). Major bleeding was observed in 26 patients (1.1%) in the rivaroxaban group and 52 patients (2.2%) in the standard-therapy group (hazard ratio, 0.49; 95% CI, 0.31 to 0.79; P=0.003). Rates of other adverse events were similar in the two groups. CONCLUSIONS: A fixed-dose regimen of rivaroxaban alone was noninferior to standard therapy for the initial and long-term treatment of pulmonary embolism and had a potentially improved benefit-risk profile. (Funded by Bayer HealthCare and Janssen Pharmaceuticals; EINSTEIN-PE ClinicalTrials.gov number, NCT00439777.).

Published
2012

36. Musculoskeletal Load in and Highly Repetitive Actions of Animal Facility Washroom Employees

Author

Kiermayer, C., Hoehne-Hückstadt, U.M., Brielmeier, M., Brütting, M., Ellegast, R., and Schmidt, J.

Subjects
Adult, Animal Experimentation, Male, Lifting, Cumulative Trauma Disorders, Physical Exertion, Posture, Video Recording, Middle Aged, Management, Biomechanical Phenomena, Weight-Bearing, Humans, Culmulative trauma disorders, Work-related factors, Upper extremity, Risk-factors, Upper limbs, Associations, Workplace, Movements, Postures, Exposure, Sanitation, Laboratories
Abstract

Regular work tasks in the washroom of laboratory animal facilities include cleaning of cages and bottles and handling of chow and bedding. These operations largely are carried out by hand. We quantitatively determined the musculoskeletal load on the trunk and upper limbs of washroom employees in an animal facility with a holding capacity of 35,000 rodent cages by using a computer-assisted, quantitative, recording, and long-term analysis (CUELA) system, which volunteers wore during routine work. Parallel video recording allowed exact assignment of each movement of body and limbs to the data recorded by the sensors. For the most part, trunk movements were unassociated with risk of injury. Evaluation of upper limb movements by CUELA indicated elevated burden on shoulder, elbows, and wrists due to the high repetitiveness and range of movements and postures. However, after additional work factors like low effort and the presence of micropauses were taken into account, workers were not at risk for the development of musculoskeletal disorders of the upper limbs. Handling bottles, chow, and bedding and maneuvering trolleys that entailed greater musculoskeletal loads did not yield evidence of overstraining, because the actions typically were executed alternately and were of short duration during daily shifts. The results represent quantitative information on the musculoskeletal load of regular washroom operations in a laboratory animal facility. These data provide the basis for ergonomic redesign of operations and implementation of automation for highly repetitive movements.

Published
2011

37. Cellular HIV-1 DNA levels in drug sensitive strains are equivalent to those in drug resistant strains in newly-diagnosed patients in Europe

Author

Demetriou, Victoria L., van de Vijver, D. A. M. C., Kousiappa, Ioanna, Balotta, Claudia, Clotet, B., Grossman, Z., Jørgensen, L. B., Lepej, S. Z., Levy, I., Nielsen, C., Paraskevis, Dimitrios N., Poljak, M., Roman, F., Ruiz, L., Schmidt, J. -C, Vandamme, A. -M, van Laethem, K. V., Vercauteren, J., Kostrikis, Leontios G., Nixon, Douglas F, Kostrikis, Leontios G. [0000-0002-5340-7109], Paraskevis, Dimitrios [0000-0001-6167-7152], and Virology

Subjects
Male, chemokine receptor CCR5, genomic DNA, peripheral blood mononuclear cell, double stranded DNA, genotype, polymerase chain reaction, Human immunodeficiency virus 1, lcsh:Medicine, HIV Infections, Drug resistance, active antiretroviral therapy, Polymerase Chain Reaction, law.invention, blood mononuclear-cells, law, Genotype, genetics, viral tropism, primer DNA, cd4(+) t-cells, lcsh:Science, Polymerase chain reaction, immunodeficiency-virus type-1, Multidisciplinary, quantitative analysis, Cellular HIV-1 DNA levels, drug resistance strains, Europe, adult, article, allele, virus diseases, Viral Load, Infectious Diseases/HIV Infection and AIDS, virology, long terminal repeat, viral load, female, real time polymerase chain reaction, Virology/Immunodeficiency Viruses, primary infection, Pol protein, Female, Viral load, Research Article, Adult, virus DNA, molecular beacon, Receptors, CCR5, Biology, untreated patients, peripheral-blood, virus RNA, disease progression, male, SDG 3 - Good Health and Well-being, Human immunodeficiency virus infection, antiviral resistance, Virology, Sequence Homology, Nucleic Acid, Drug Resistance, Viral, Infectious Diseases/Sexually Transmitted Diseases, proteinase inhibitor, Humans, controlled study, human, Gene, Tropism, Alleles, DNA Primers, Base Sequence, human cell, chemokine receptor CXCR4, Virology/Persistence and Latency, lcsh:R, CD4 lymphocyte count, nucleotide sequence, sequence homology, virus load, nonnucleoside reverse transcriptase inhibitor, Human immunodeficiency virus 1 infection, DNA extraction, major clinical study, Viral Tropism, virus genome, lifelong persistence, Immunology, DNA, Viral, Tissue tropism, HIV-1, lcsh:Q, Human medicine
Abstract

Background HIV-1 genotypic drug resistance is an important threat to the success of antiretroviral therapy and transmitted resistance has reached 9% prevalence in Europe. Studies have demonstrated that HIV-1 DNA load in peripheral blood mononuclear cells (PBMC) have a predictive value for disease progression, independently of CD4 counts and plasma viral load. Methodology/Principal Findings Molecular-beacon-based real-time PCR was used to measure HIV-1 second template switch (STS) DNA in PBMC in newly-diagnosed HIV-1 patients across Europe. These patients were representative for the HIV-1 epidemic in the participating countries and were carrying either drug-resistant or sensitive viral strains. The assay design was improved from a previous version to specifically detect M-group HIV-1 and human CCR5 alleles. The findings resulted in a median of 3.32 log10 HIV-1 copies/106 PBMC and demonstrated for the first time no correlation between cellular HIV-1 DNA load and transmitted drug-resistance. A weak association between cellular HIV-1 DNA levels with plasma viral RNA load and CD4+ T-cell counts was also reconfirmed. Co-receptor tropism for 91% of samples, whether or not they conferred resistance, was CCR5. A comparison of pol sequences derived from RNA and DNA, resulted in a high similarity between the two. Conclusions/Significance An improved molecular-beacon-based real-time PCR assay is reported for the measurement of HIV-1 DNA in PBMC and has investigated the association between cellular HIV-1 DNA levels and transmitted resistance to antiretroviral therapy in newly-diagnosed patients from across Europe. The findings show no correlation between these two parameters, suggesting that transmitted resistance does not impact disease progression in HIV-1 infected individuals. The CCR5 co-receptor tropism predominance implies that both resistant and non-resistant strains behave similarly in early infection. Furthermore, a correlation found between RNA- and DNA-derived sequences in the pol region suggests that genotypic drug-resistance testing could be carried out on either template. © 2010 Demetriou et al. 5 Cited By :7

Published
2010

38. Once-daily prolonged-release Tacrolimus (ADVAGRAF) versus twice-daily Tacrolimus (PROGRAF) in liver transplantation

Author

Trunecka, P, Boillot, O, Seehofer, D, Pinna, Ad, Fischer, L, Ericzon, Bg, Troisi, Ri, Baccarani, U, ORTIZ DE URBINA, J, Wall, W, Mccaughan, G, Jones, R, DE ROOVER, A, Mies, S, Moreira, L, Lima, A, Cantisani, G, Kneteman, N, Grant, D, Roy, A, Scudamore, C, Tchervenkov, J, Clavien, P, Candinas, D, Schmidt, J, Schlitt, J, Bilbao, I, Charco, R, Pera, C, Bernardos, A, MIR PALLARDO, J, Varo, E, Isoniemi, H, Rostaing, L, Samuel, D, Pageaux, G, Durand, F, Duvoux, C, Boudjema, K, Wolf, P, Burroughs, A, O' GRADY, J, Prasad, R, Manas, D, Mccormick, A, Colledan, M, Valente, Umberto, Gerunda, G, Gridelli, B, Bentdal, O, Munn, S, Paczek, L, Bäckman, L., Trunecka P., Boillot O., Seehofer D., Pinna A.D., Fischer L., Ericzon B.G., Troisi R.I., Baccarani U., Ortiz de Urbina J., Wall W., and Tacrolimus Prolonged Release Liver Study Group

Subjects
Adult, Graft Rejection, Male, medicine.medical_specialty, Randomization, medicine.medical_treatment, Urology, chemical and pharmacologic phenomena, Liver transplantation, Kidney Function Tests, Tacrolimus, Daclizumab, medicine, Humans, Immunology and Allergy, Pharmacology (medical), Adverse effect, Antibacterial agent, Transplantation, Protein synthesis inhibitor, business.industry, tacrolimu, Middle Aged, Liver Transplantation, Surgery, Multicenter Study, Calcineurin, Treatment Outcome, surgical procedures, operative, Randomized Controlled Trial, Immunosuppression, Steroids, RCT, Female, business, Immunosuppressive Agents, medicine.drug
Abstract

The efficacy and safety of dual-therapy regimens of twice-daily tacrolimus (BID; Prograf) and once-daily tacrolimus (QD; Advagraf) administered with steroids, without antibody induction, were compared in a multicenter, 1:1-randomized, two-arm, parallel-group study in 475 primary liver transplant recipients. A double-blind, double-dummy 24-week period was followed by an open extension to 12 months posttransplant. The primary endpoint, event rate of biopsy-proven acute rejection (BPAR) at 24 weeks, was 33.7% for tacrolimus BID versus 36.3% for tacrolimus QD (Per-protocol set; p = 0.512; treatment difference 2.6%, 95% confidence interval -7.3%, 12.4%), falling within the predefined 15% noninferiority margin. At 12 months, BPAR episodes requiring treatment were similar for tacrolimus BID and QD (28.1% and 24.7%). Twelve-month patient and graft survival was 90.8% and 85.6% for tacrolimus BID and 89.2% and 85.3% for tacrolimus QD. Adverse event (AE) profiles were similar for both tacrolimus BID and QD with comparable incidences of AEs and serious AEs. Tacrolimus QD was well tolerated with similar efficacy and safety profiles to tacrolimus BID.

Published
2010

39. Distinct inflammatory properties of late-activated macrophages in inflammatory myopathies

Author

Rostasy, KM, Schmidt, J, Bahn, E, Pfander, T, Piepkorn, M, Wilichowski, E, and Schulz-Schaeffer, J

Subjects
Adult, Interferon-gamma, Transforming Growth Factor beta, Macrophages, Antigens, Differentiation, Myelomonocytic, Humans, Nitric Oxide Synthase Type II, Original Article, Child, Immunohistochemistry, Dermatomyositis, Polymyositis
Abstract

Distinct mechanisms such as humeral immunity in dermatomyositis (DM) and T-cell-mediated cytotoxicity in polymyositis (PM) contribute to the pathology of inflammatory myopathies. In addition, different subsets of macrophages are present in both diseases. Herein, the characteristics of 25F9-positive macrophages in skeletal muscle inflammation are outlined. Muscle biopsies of subjects with DM and PM were studied by immunohistochemical multi-labelling using the late-activation marker 25F9, together with markers characterizing macrophage function including IFN-gamma, iNOS, and TGF-beta. In PM, a robust expression of IFN-gamma, iNOS, and TGF-beta was observed in inflammatory cells. Double- and serial-labelling revealed that a subset of 25F9-positive macrophages in the vicinity of injured muscle fibres expressed iNOS and TGF-beta, but not IFN-gamma. In DM, IFN-gamma, iNOS and TGF-beta were also expressed in inflammatory cells in the endomysium. Double- and serial-labelling studies in DM indicated that 25F9-positive macrophages expressed TGF-beta and to a lesser degree iNOS, but not IFN-gamma. In conclusion, our data suggest that late-activated macrophages contribute to the pathology of inflammatory myopathies.

Published
2008

40. [Terminal illness, death... in the words of professionals. A qualitative study based on in-depth interviews with health professionals]

Author

García M P, Caro, Schmidt J, Rio-Valle, Cruz F, Quintana, Prados D, Peña, Muñoz A, Vinuesa, and Athanasios, Pappous

Subjects
Interviews as Topic, Terminal Care, Attitude to Death, Attitude of Health Personnel, Health Personnel, Humans, Vocabulary
Abstract

The authors of this study are interested in listening to the experiences professional doctors and nurses who work face to face with patients in terminal phase of their illnesses have. For this reason, the authors carried out a series of in-depth interviews with these professionals in order to know the real difficulties and obstacles which these professionals experience in real cases, as well as the procedure methods followed with these patients. The authors publish the results obtained in eight of these interviews, four with doctors and four with nurses; given the length of these interviews, the authors have decided to publish them in two consecutive articles which form one complete study This study is qualitative and the analysis of data obtained has been structured around the proposed research questions, keeping the diversity and variability how to deal with patients, plus the experiences shown by those interviewed, by citing their words textually.

Published
2008

41. [Opiate dependent pregnant patients and mothers. What must be regarded in drug substitution and detoxification]

Author

Schwejda C, Bystron C, Federmann M, Schmidt J, Bussello-Spieth S, and Felix Tretter

Subjects
Patient Care Team, Pregnancy Complications, Patient Admission, Pregnancy, Germany, Ambulatory Care, Infant, Newborn, Humans, Female, Opioid-Related Disorders, Neonatal Abstinence Syndrome, Methadone
Abstract

Substitution treatment with methadone, is a major addition to the therapeutic options available to opiate-dependent patients. In the case of opiate-dependent pregnant women and mothers with children, however, it brings other problems with it. Thus, for example, cases of methadone poisoning of children have become known. In part these are accidental, but some are a result of deliberate attempts on the part of mothers to quieten their children. The present report from an outpatient addiction service describes specific possibilities for treatment, and offers of organized help for this group of patients.

Published
2001

42. Intravenous NPA for the treatment of infarcting myocardium early; InTIME-II, a double-blind comparison of single-bolus lanoteplase vs accelerated alteplase for the treatment of patients with acute myocardial infarction

Author

Braunwald, E., Neuhaus, K. -L., Antman, E., Chew, P., Skene, A., Wilcox, R., Ambrosioni, E., Anderson, J., Apetrei, E., Bata, I., Carrageta, M., Col, J., Dalby, A., Davies, R., Deckers, J., Eichman, D., Grande, P., Greene, R., Gurfinkel, E., Heikkilä, J., Henry, T., Hillis, D., Hochman, J., Huber, K., Kostis, J., Klinke, P., López-Sendón, J., Mckendall, G., Móller, B., Moore, P., Morris, A., Mueller, H., Östör, E., Oto, A., Ruda, M., Sadowski, Z., Schweiger, M., Sequeira, R., Shah, P., Shannon, R., Smith, B., Sobel, B., Steingart, R., Tebbe, U., Toman, J., Traboulsi, M., Vahanian, A., Warnica, J. W., Willerson, J., Deitchman, D., Davidson, L., Folgia, T., Foxley, A., Goodman, J., Hauck, C., Henry, D., Mccabe, C., Pangerl, A., Thomson, A., Wagner, M., Kennedy, J. W., Cairns, J., Demets, D., Julian, D., Simoons, M., Charlesworth, A., Easton, J. D., Ferbert, A., Feske, S., Kuhn, P., Moseley, J., Rogg, J. M., Reichmann, H., Sloan, M., von Kummer, R., Zamani, A., Coulter, S., Giugliano, R., Skene, A. M., Ardill, R., Ince, Y., Peters, A., Ward, K., Wolf, L., Curtis, N., De Brés, J., Stead, S., Watson, S., Cutler, S., Friedman, J., Helfrick, R., Williams, S., Klimovsky, J., Kumagai, S., Adams, E., Anderson, C., Bauhuber, I., Bennett, L., Biro, E., Boyce, E., Bregman, B., Carvalho, P., Ciganovic, D., Csukas, M., Cuenca, P., De Cuyper, S., Diez, P., Dijkhuizen, M., Dille-Amo, C., Gonzalez-Santis, A., Gursoy, M., Hammarstrom, K., Harasta, E., Ingman, E., Kelemen, B., Keulen, I., Koren, A., Langthaler, G., Lemaire, F., Little, I., Montalban, C., Nijssen, K., Neumueller, I., Palander, M., Pekuri, T., Persson, U., Pilz, J., Oudotova, S., Pisklakov, V., Proinov, F., Ptaszynska, A., Read, J., Retei, S., Romeyer, F., Romanini, M., Saar, L., Salein, D., Samsonov, M., Simeon-Dubach, D., Simmonds, J., Skaza, M., Skvortsova, N., Smidlova, Z., Spitzerova, H., Strijdveen, I., Szajewski, T., Ugurnal, B., Valcarce, M., van Rompaey, I., Walker, A., Zak, E., Zimova, N., Barrero, C., Beck, E., Bruno, M. L., Caccavo, A., Cagide, A., Campo, A., Cermesoni, R., Chahin, M., Dutra, O., Estrada, J., Falu, E. A., Gagliardi, J., Garre, L. E., Liprandi, A. S., Luciardi, H., Mautner, B., Muntaner, J., Nau, G., Salzberg, S., Santopinto, J., Sinisi, A., Torres, H., Eber, B., Elliott, P., Hiemetsberger, H., Juhasz, M., Kühn, P., Leisch, F., Niktardjam, M., Reisinger, J., Schmalix, G., Schuster, R., Sihorsch, K., Silberhauer, K., Slany, J., Steinbach, K., Tragl, K. H., Valentin, A., Al Shwafi, K., Dasnoy, P., De Clippel, M., de Meester, A., De Raedt, H. J. L. P., Emonts, M., Evrard, P., Eycken, M., Geboers, M., Heyndrickx, G., Lauwers, K., Mitrie, K., Pirenne, B., Renard, M., Somers, Y., Timmermans, P., Van Kuyk, M., Van Mieghem, W., Vermeulen, J., Verrostte, J. M., Albuquerque, D., Ayoub, J. C. A., Carvalho, A., Cesar, L., Gebara, O., Golin, V., Knobel, E., Leaes, P., Neto, J. A. M., Nicolau, J. C., Piegas, L. S., Rabelo, A., Rassi, A., Sila, L., Simao, A. 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S., Lahiri, A., Lawson, C., Lewis, R., Macdermott, A. F. N., Mackay, A., Macleod, D. C., Mccance, A. J., Morrison, A., Mortimer, M., Mulvey, D., Murphy, J. J., Murray, S., Muthusamy, R., Myers, A., Nicolson, V. G., Northridge, D., Odemuyiwa, S., Oldroyd, K. G., Oliver, R. M., Pell, A. C. H., Pohl, J. E. F., Price, B., Quereshi, N., Rae, A. P., Reader, S., Reid, D. S., Reynolds, G. W., Robinson, A., Robson, R. H., Rodger, J. C., Rodrigues, E., Rose, E. L., Rowlands, D. B., Rowley, J. M., Rozkovec, A., Shreeve, J., Siklos, P., Smith, R. H., Sneddon, J. F., Somasundram, U., Squire, I., Stephens, J. D., Stephens-Lloyd, A., Strand, J. M., Stuart, J., Sutaria, N., Swan, J., Tait, G. W., Thomas, R. D., Thompson, M. A., Tildesley, G., Travill, C. M., Treadgold, J. A., Trelawney, J. M. S., Turner, D., Vallance, B. D., Wallbridge, D., Weissberg, P. L., White, E., Wicks, M., Wilcox, R. G., Wilkinson, P., Wiltshire, J. E., Wright, A., Andrea, B., Attassi, K., Bahr, R., Banas, J., Baran, K., Belknap, M., Bensman, M., Bertolet, B., Besley, D., Bethala, V., Betzu, R., Bhalla, R., Bhargava, M., Binder, A., Birkhead, R., Bodine, K., Brewer, D., Carey, S., Chengot, M., Coppola, J., Cragg, D., D’Arcy, B., Denny, D. M., Dilorenzo, P., Dixon, E., Doorey, A., Doty, D., Doty, W., Drossner, M., Eisenberg, P., Falco, T., Feldman, R., Freman, I., Frey, M., Garcia, J., Glassman, J., Goldman, S., Gomez, M., Gonzalez, M., Goodfield, P., Gottlieb, S., Grech, D., Hack, T., Haffey, T., Hanson, J., Havranek, E., Hermany, P., Hernandez, H., Herron, R., Hession, W., Hines, J., Hundley, R., Jacobs, W. C., Jerjes-Sanchez, C., Jerome, S., Josephson, R., Kalan, J., Kawalsky, D., Khan, A., Kmetzo, K., Kraemer, M., Lader, E., Landis, J., Lash, J., Leber, R., Leimbach, W., Leiva Garza, J. -L., Maddox, W., Magorien, R., Mahapatra, S., Mantecon, I., Mendelson, R., Miklin, J., Milas, J., Miller, R., Molk, B., Monrad, E. S., Morrison, J., Morse, H., Neustel, M., Nichols, D., Niederman, A., Nygaard, T., O’Connor, R., O’Riordan, W., Obermueller, S., Palmeri, S., Patel, R., Paul, T., Phiambolis, T., Piana, R., Polansky, B., Polinski, W., Ponce, G., Ribeiro, P., Roccario, E., Rogers, C. P., Rogers, W., Rosenblatt, A., Runyon, J. P., Scheel, F., Schmidt, P., Schneider, R., Schwartz, H., Shelhamer, L., Sheridan, F., Shine, W., Shook, T., Siskind, S., Slama, R., Spear, E., Stouffer, G., Strunk, B., Thadani, U., Timmis, G., Trautloff, R., Tse, A., Wohl, B., Zarren, H., Zucker, R., Kuster, F., and Pardie, J. P.

Subjects
Male, Risk, Infusions, medicine.medical_treatment, Myocardial Infarction, Bolus lytic therapy, Acute myocardial infarction, Tissue plasminogen activator, Thrombolytic drug, Double-Blind Method, Fibrinolytic Agents, medicine, Humans, Thrombolytic Therapy, Myocardial infarction, Infusions, Intravenous, Stroke, Aged, business.industry, ST elevation, Lanoteplase, Emergency department, Middle Aged, medicine.disease, Survival Analysis, Regimen, Relative risk, Anesthesia, Tissue Plasminogen Activator, Female, Intracranial Hemorrhages, Cardiology and Cardiovascular Medicine, business, Intravenous, medicine.drug
Abstract

AIMS To compare the efficacy and safety of lanoteplase, a single-bolus thrombolytic drug derived from alteplase tissue plasminogen activator, with the established accelerated alteplase regimen in patients presenting within 6 h of onset of ST elevation acute myocardial infarction. METHODS AND RESULTS 15,078 patients were recruited from 855 hospitals worldwide and randomized in a 2:1 ratio to receive either lanoteplase 120 KU. kg(-1)as a single intravenous bolus, or up to 100 mg accelerated alteplase given over 90 min. The primary end-point was all-cause mortality at 30 days and the hypothesis was that the two treatments would be equivalent. By 30 days, 6.61% of alteplase-treated patients and 6.75% lanoteplase-treated patients had died (relative risk 1.02). Total stroke occurred in 1.53% alteplase- and 1.87% lanoteplase-treated patients (ns); haemorrhagic stroke rates were 0.64% alteplase and 1.12% lanoteplase (P=0.004). The net clinical deficit of 30-day death or non-fatal disabling stroke was 7.0% and 7.2%, respectively. By 6 months, 8.8% of alteplase-treated patients and 8.7% of lanoteplase-treated patients had died. CONCLUSION Single-bolus weight-adjusted lanoteplase is an effective thrombolytic agent, equivalent to alteplase in terms of its impact on survival and with a comparable risk-benefit profile. The single-bolus regimen should shorten symptoms to treatment times and be especially convenient for emergency department or out-of-hospital administration.

Published
2000

43. A comparison of capitated and fee-for-service Medicaid reimbursement methods on pregnancy outcomes

Author

Oleske, D M, Branca, M L, Schmidt, J B, Ferguson, R, and Linn, E S

Subjects
Adult, Adolescent, Medicaid, Cost-Benefit Analysis, Managed Care Programs, Infant, Newborn, Pregnancy Outcome, Fee-for-Service Plans, Prenatal Care, Infant, Low Birth Weight, Middle Aged, California, United States, Reimbursement Mechanisms, Pregnancy, Outcome Assessment, Health Care, Humans, Female, Capitation Fee, Hospital Costs, Child, Research Article
Abstract

OBJECTIVE: To determine if the payment method influenced the likelihood of selected obstetrical process measures and pregnancy outcome indicators among Medicaid women. DATA SOURCE/STUDY SETTING: Data from the live birth certificates computer file for 1993 from the State of California. The computer files contain information about the demographic characteristics of the mother, her medical conditions prior to delivery, medical problems during labor and delivery, delivery method, newborn and maternal outcomes, and expected principal source of payment for prenatal care and for hospital delivery. STUDY DESIGN: The study sample consisted of singleton live births to women in the California Medi-Cal program residing in one of two counties in which a mixed-model managed care plan was the method of reimbursement or in one of three counties in which fee-for-service was the payment method. The study and control counties were matched in terms of geographic proximity and sociodemographics. PRINCIPAL FINDINGS: Among Medi-Cal women, the likelihood of low birth weight (LBW) was lower in the capitated payment group than in the fee-for-service payment group even when controlling for maternal and newborn characteristics and adequacy of prenatal care. There was no difference in either the adequacy of prenatal care, the cesarean birth rate, or the likelihood of adverse pregnancy outcomes other than LBW between the two payer groups. CONCLUSIONS: Results of this "natural experiment" suggest that enrollment of pregnant Medi-Cal beneficiaries in capitated healthcare services through a primary care case management system in a county-organized health system/health insuring organization can have a beneficial effect on low birth weight and provide care comparable to a fee-for-service system.

Published
1998

45. A rural emergency department

Author

Frey, L, Schmidt, J, Derksen, D J, and Skipper, B

Subjects
Adult, Male, Adolescent, Child, Preschool, Hospitals, Rural, Humans, Infant, Female, Middle Aged, Child, Emergency Service, Hospital, humanities, Research Article
Abstract

The appropriate use of emergency departments is of growing concern. By knowing which patients are more likely to make inappropriate visits to these departments, efforts can be directed to encourage more suitable care. Our study was done in a rural county hospital in eastern New Mexico. Data were collected from all emergency department visits over a 4-week period. Patient and physician questionnaires were administered to assess aspects of emergency department use, including appropriateness based on published criteria, physicians' opinion of appropriateness, groups who made inappropriate visits, and the perception of the need for and the urgency of a visit. We found that 32% of visits were inappropriate based on published criteria and 24% were considered inappropriate by physician opinion. Two groups with a high rate of inappropriate visits were Hispanics and Medicaid recipients. Patients and physicians have differing opinions of the urgency of a visit and of how soon medical treatment is required. To decrease the frequency of inappropriate use of emergency departments, educational efforts should be focused on the subgroups with high rates of such use.

Published
1994

46. Medical treatment of benign prostatic hyperplasia

Author

Schmidt, J. D.

Subjects
Male, 5-alpha Reductase Inhibitors, Azasteroids, Finasteride, Goserelin, Prostatic Hyperplasia, Humans, Androgen Antagonists, Androstenes, Leuprolide, Buserelin, Adrenergic alpha-Antagonists, Research Article
Published
1991

48. Nitrendipine Treatment in So-Called Therapy-Resistant Arterial Hypertension; Effect as Monotherapy and in Combination with Propranolol on Blood Pressure, Heart Rate, Other Hemodynamic Parameters, Plasma Renin Activity, and Catecholamines

Author

Faulhaber Hd, Homuth, Schmidt J, Hartrodt W, Menz M, Mohnike W, Gruner R, and Naumann E

Subjects
Male, medicine.medical_specialty, Supine position, viruses, Drug Resistance, Hemodynamics, Blood Pressure, Propranolol, Plasma renin activity, Catecholamines, Nitrendipine, Heart Rate, Internal medicine, Renin, Heart rate, Humans, Medicine, Pharmacology, business.industry, Middle Aged, medicine.disease, Endocrinology, Blood pressure, Pathophysiology of hypertension, Hypertension, Cardiology, Drug Therapy, Combination, Female, Vascular Resistance, Cardiology and Cardiovascular Medicine, business, medicine.drug
Abstract

Twenty-three patients [mean age 49.7 +/- 5.6 years (WHO II-III)] with severe hypertension and not responding to previous drug treatment were included in the study to evaluate the effect of nitrendipine (NTP) as monotherapy and also in combination with propranolol (PRO). After a control period of 10 days, NTP was started with 20 mg twice a day and titrated to the maximal dosage of 2 X 40 mg/day. After 1 week of NTP treatment, PRO was added in increasing dosage to a maximal 2 X 100 mg/day. NTP lowered systolic and diastolic blood pressure (BP) significantly (supine BP from 182/119 +/- 19/9 to 157/98 +/- 16/9 mm Hg). After combination with PRO, systolic BP was decreased additionally (supine BP from 157/98 +/- 16/9 to 150/97 +/- 19/9 mm Hg). Plasma norepinephrine (NE) was increased by NTP (from 1.82 +/- 0.78 to 2.38 +/- 1.08 nmol/l, p less than 0.01) and remained elevated during PRO treatment (2.76 +/- 1.10 nmol/l). Plasma renin activity (PRA) showed no significant changes by NTP. Additional effect of PRO on BP correlated significantly with NE and PRA after the NTP period. Plasma epinephrine and dopamine beta-hydroxylase remained unchanged. NTP decreased systemic resistance, calculated from isotope dilution technique (p less than 0.05); after combination with PRO no additional significant changes were registered. Nitrendipine is an effective alternative in so-called therapy-resistant hypertension.

Published
1988

49. Antibodies to interleukin-1 raised with synthetic peptides: identification of external sites and analysis of interleukin-1 synthesis in stimulated human peripheral blood monocytes

Author

Bomford, R, Abdulla, E, Hughes-Jenkins, C, Simpkin, D, and Schmidt, J

Subjects
Molecular Weight, Antibody Formation, Animals, Humans, Electrophoresis, Polyacrylamide Gel, Rabbits, Monocytes, Peptide Fragments, Recombinant Proteins, Research Article, Interleukin-1
Abstract

Rabbit antibodies against peptides corresponding to amino acids 1-18, 45-65 and 71-90 of mature human interleukin-1 beta (IL-1 beta) precipitated 125I-labelled IL-1 beta, showing that these sites are accessible to antibody and located externally. Immunoprecipitation of 35S-methionine-labelled LPS-stimulated human peripheral blood monocytes followed by SDS-PAGE revealed the expected major bands of molecular weights 35,000 and 17,500. The 35,000 protein was found in the cell lysate and extracellularly in the medium, but the 17,500 protein was exclusively in the medium. A previously undescribed 31,000 band was also detected in the medium. These results are most simply explained by the hypothesis that the 35,000 IL-1 beta precursor is released from the cell and processed extracellularly to the 17,500 mature form. The 31,000 molecule may represent a processing intermediate.

Published
1987

50. [Interest of S100B protein blood level determination for the management of patients with minor head trauma]

Author

Bouvier, Damien, Bouvier, M., Oddoze, C, Ben Haim, D, Moustafa, M, Legrand, A., Alazia, M, Jehle, J, Schmidt, J, Sapin, V., Génétique, Reproduction et Développement (GReD ), Institut National de la Santé et de la Recherche Médicale (INSERM)-Université Clermont Auvergne [2017-2020] (UCA [2017-2020])-Centre National de la Recherche Scientifique (CNRS), Université Clermont Auvergne [2017-2020] (UCA [2017-2020]), Centre de recherche en neurobiologie - neurophysiologie de Marseille (CRN2M), Aix Marseille Université (AMU)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Centre National de la Recherche Scientifique (CNRS), IRCELYON-Ingéniérie, du matériau au réacteur (ING), Institut de recherches sur la catalyse et l'environnement de Lyon (IRCELYON), Université Claude Bernard Lyon 1 (UCBL), Université de Lyon-Université de Lyon-Centre National de la Recherche Scientifique (CNRS)-Institut de Chimie du CNRS (INC)-Université Claude Bernard Lyon 1 (UCBL), Université de Lyon-Université de Lyon-Centre National de la Recherche Scientifique (CNRS)-Institut de Chimie du CNRS (INC), Université de Lyon-Université de Lyon-Institut de Chimie du CNRS (INC)-Centre National de la Recherche Scientifique (CNRS)-Université Claude Bernard Lyon 1 (UCBL), and Université de Lyon-Université de Lyon-Institut de Chimie du CNRS (INC)-Centre National de la Recherche Scientifique (CNRS)

Subjects
Adult, Male, genetic structures, Patient Selection, [SDV]Life Sciences [q-bio], S100 Proteins, S100 Calcium Binding Protein beta Subunit, Middle Aged, Sensitivity and Specificity, eye diseases, Hospitals, University, Young Adult, Craniocerebral Trauma, Humans, Female, France, Nerve Growth Factors, Prospective Studies, sense organs, Tomography, X-Ray Computed, Biomarkers
Abstract

International audience; Indication of cranial computed tomography (CCT) for patients with head minor injury (MHI) is difficult. Actually, 90% of patients with MHI who have CCT under the present clinical decision rules have normal scans. Serum concentrations of the protein S-100B were recently found to provide useful information. We have investigated whether S-100B concentrations in patients with MHI can provide additional information to improve indication of the need for an initial CCT scan. One hundred five patients with MHI were enrolled in this prospective study, at the French university hospital of Marseille and Clermont-Ferrand. Of the 105 patients studied, 16 exhibited trauma-relevant intracerebral lesions on the CCT scan (CCT+). With a cut-off limit of 0,10 microg/L S-100B, CCT+ patients were identified with a sensitivity level of 100% and a specificity level of 33%. Adding the measurement of S-100B serum concentration to the clinical decision rules for a CCT scan in patients with MHI could allow a 30% reduction in scans.

Published
1970

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