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1. Stopping or maintaining oral anticoagulation in patients undergoing photoselective vaporization of the prostate (SOAP) surgery for benign prostate obstruction: study protocol for a multicentre randomized controlled trial

Author

Hélène Charbonneau, Marie Pasquié, Benoit Peyronnet, Aurélien Descazeaud, Nicolas Barry-Delongchamps, Emmanuel Della Negra, Romain Mathieu, Gilles Karsenty, Jean-Alexandre Long, Charles Ballereau, Abdel-Rahmène Azzouzi, Benjamin Pradère, Franck Bruyère, Georges Fournier, Souhil Lebdai, Jehanne Calves, Luc Corbel, Sébastien Vincendeau, Gaelle Fiard, Caroline Thuillier, Jean-Luc Descotes, Pierre Colin, Thibaut Culty, Audrey Hesbois, Valerie Fuzier, Nicolas Savy, Atul Pathak, Pierre Albaladejo, Charles Marc Samama, Felipe Guerrero, and Vincent Misraï

Subjects
Benign prostatic obstruction, GreenLight, Laser, Oral anticoagulation, Complications, Medicine (General), R5-920
Abstract

Abstract Background Lower urinary tract symptoms related to benign prostatic obstruction (BPO) are frequent in men aged > 50 years. Based on the use of innovative medical devices, a number of transurethral ablative techniques have recently been developed for the surgical treatment of BPO. In recent years, GreenLight photoselective vaporization of the prostate (PVP) has been considered as a non-inferior alternative to transurethral resection of the prostate. The GreenLight PVP is usually considered as an interesting surgical option for patients treated via oral anticoagulants (OACs) with regard to its haemostatic properties. The aim of this study was to assess the impact of maintaining OAC treatment in patients undergoing PVP. Methods This study is a multicentre, open-label, randomized controlled trial (RCT) designed to show the non-inferiority of PVP surgery in patients with BPO treated with OACs. This study is designed to enrol 386 OAC-treated patients (treated with vitamin K antagonists and direct oral anticoagulants) who are undergoing PVP for BPO. Patients will be randomized (1:1) to either maintain or stop OAC treatment during the perioperative course. The intervention group will maintain OAC treatment until the day before surgery and resume OAC treatment the day after surgery, whereas the control group will stop OAC treatment (with or without low-molecular-weight heparin bridging therapy) according to the anaesthesia guidelines. The primary outcome of interest to be assessed is the 30-day complications rate according to the Clavien-Dindo classification. The secondary endpoint will examine the 30-day rate of haemorrhagic and thrombotic events. This study will provide 80% power to show non-inferiority, defined as not worse than a 10% (non-inferiority margin) inferior change in the proportion of patients with good outcomes (Clavien-Dindo score

Published
2018
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2. Delphi-consensus weights for ischemic and bleeding events to be included in a composite outcome for RCTs in thrombosis prevention.

Author

Agnes Dechartres, Pierre Albaladejo, Jean Mantz, Charles Marc Samama, Jean-Philippe Collet, Philippe Gabriel Steg, Philippe Ravaud, and Florence Tubach

Subjects
Medicine, Science
Abstract

To weight ischemic and bleeding events according to their severity to be used in a composite outcome in RCTs in the field of thrombosis prevention.Using a Delphi consensus method, a panel of anaesthesiology and cardiology experts rated the severity of thrombotic and bleeding clinical events. The ratings were expressed on a 10-point scale. The median and quartiles of the ratings of each item were returned to the experts. Then, the panel members evaluated the events a second time with knowledge of the group responses from the first round. Cronbach's a was used as a measure of homogeneity for the ratings. The final rating for each event corresponded to the median rating obtained at the last Delphi round.Of 70 experts invited, 32 (46%) accepted to participate. Consensus was reached at the second round as indicated by Cronbach's a value (0.99 (95% CI 0.98-1.00)) so the Delphi was stopped. Severity ranged from under-popliteal venous thrombosis (median = 3, Q1 = 2; Q3 = 3) to ischemic stroke or intracerebral hemorrhage with severe disability at 7 days and massive pulmonary embolism (median = 9, Q1 = 9; Q3 = 9). Ratings did not differ according to the medical specialty of experts.These ratings could be used to weight ischemic and bleeding events of various severity comprising a composite outcome in the field of thrombosis prevention.

Published
2011
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3. The European guideline on management of major bleeding and coagulopathy following trauma: sixth edition

Author

Rolf Rossaint, Arash Afshari, Bertil Bouillon, Vladimir Cerny, Diana Cimpoesu, Nicola Curry, Jacques Duranteau, Daniela Filipescu, Oliver Grottke, Lars Grønlykke, Anatole Harrois, Beverley J. Hunt, Alexander Kaserer, Radko Komadina, Mikkel Herold Madsen, Marc Maegele, Lidia Mora, Louis Riddez, Carolina S. Romero, Charles-Marc Samama, Jean-Louis Vincent, Sebastian Wiberg, and Donat R. Spahn

Subjects
Emergency medicine, Trauma, Traumatic coagulopathy, Major bleeding, Haemostasis, Practice guideline, Medical emergencies. Critical care. Intensive care. First aid, RC86-88.9
Abstract

Key messages Immediate detection and management of traumatic coagulopathy improves outcomes of severely injured patients. This guideline follows management of the severe trauma patient in chronological order, with a focus on prevention of possible exsanguination. These structured recommendations support measures that prioritise the optimisation of resources for the benefit of bleeding control based on scientific evidence. Empirical management should not be implemented unless no method of monitoring bleeding and coagulation is available. Optimal organisation of the resuscitation team for the bleeding trauma patient includes implementation of these guidelines.

Published
2023
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4. Perioperative management of patients on direct oral anticoagulants

Author

Virginie Dubois, Anne-Sophie Dincq, Jonathan Douxfils, Brigitte Ickx, Charles-Marc Samama, Jean-Michel Dogné, Maximilien Gourdin, Bernard Chatelain, François Mullier, and Sarah Lessire

Subjects
Anticoagulants, Perioperative period, Invasive procedures, Spinal anesthesia, Emergency care, Blood coagulation test, Diseases of the blood and blood-forming organs, RC633-647.5
Abstract

Abstract Direct oral anticoagulants (DOACs) have been licensed worldwide for several years for various indications. Each year, 10–15% of patients on oral anticoagulants will undergo an invasive procedure and expert groups have issued several guidelines on perioperative management in such situations. The perioperative guidelines have undergone numerous updates as clinical experience of emergency management has increased and perioperative studies including measurement of residual anticoagulant levels have been published. The high inter-patient variability of DOAC plasma levels has challenged the traditional recommendation that perioperative DOAC interruption should be based only on the elimination half-life of DOACs, especially before invasive procedures carrying a high risk of bleeding. Furthermore, recent publications have highlighted the potential danger of heparin bridging use when DOACs are stopped before an invasive procedure. As antidotes are progressively becoming available to manage severe bleeding or urgent procedures in patients on DOACs, accurate laboratory tests have become the standard to guide their administration and their actions need to be well understood by clinicians. This review aims to provide a systematic approach to managing patients on DOACs, based on recent updates of various perioperative guidance, and highlighting the advantages and limits of recommendations based on pharmacokinetic properties and laboratory tests.

Published
2017
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5. ISTH guidelines for antithrombotic treatment in COVID-19

Author

Sam Schulman, Michelle Sholzberg, Alex C. Spyropoulos, Ryan Zarychanski, Helaine E. Resnick, Charlotte A. Bradbury, Jean Marie Connors, Anna Falanga, Toshiaki Iba, Scott Kaatz, Jerrold H. Levy, Saskia Middeldorp, Tracy Minichiello, Eduardo Ramacciotti, Charles Marc Samama, Jecko Thachil, Lisa Broxmeyer, null International Society on Thrombosis and Haemostasis, Vascular Medicine, ACS - Pulmonary hypertension & thrombosis, and ARD - Amsterdam Reproduction and Development

Subjects
anticoagulants, Heparin, Critical Illness, Vascular damage Radboud Institute for Health Sciences [Radboudumc 16], Aftercare, Anticoagulants, COVID-19, Hematology, Heparin, Low-Molecular-Weight, Patient Discharge, Fibrinolytic Agents, Rivaroxaban, Humans, critical illness, platelet aggregation inhibitors, Platelet Aggregation Inhibitors
Abstract

Contains fulltext : 282327.pdf (Publisher’s version ) (Closed access) Antithrombotic agents reduce risk of thromboembolism in severely ill patients. Patients with coronavirus disease 2019 (COVID-19) may realize additional benefits from heparins. Optimal dosing and timing of these treatments and benefits of other antithrombotic agents remain unclear. In October 2021, ISTH assembled an international panel of content experts, patient representatives, and a methodologist to develop recommendations on anticoagulants and antiplatelet agents for patients with COVID-19 in different clinical settings. We used the American College of Cardiology Foundation/American Heart Association methodology to assess level of evidence (LOE) and class of recommendation (COR). Only recommendations with LOE A or B were included. Panelists agreed on 12 recommendations: three for non-hospitalized, five for non-critically ill hospitalized, three for critically ill hospitalized, and one for post-discharge patients. Two recommendations were based on high-quality evidence, the remainder on moderate-quality evidence. Among non-critically ill patients hospitalized for COVID-19, the panel gave a strong recommendation (a) for use of prophylactic dose of low molecular weight heparin or unfractionated heparin (LMWH/UFH) (COR 1); (b) for select patients in this group, use of therapeutic dose LMWH/UFH in preference to prophylactic dose (COR 1); but (c) against the addition of an antiplatelet agent (COR 3). Weak recommendations favored (a) sulodexide in non-hospitalized patients, (b) adding an antiplatelet agent to prophylactic LMWH/UFH in select critically ill, and (c) prophylactic rivaroxaban for select patients after discharge (all COR 2b). Recommendations in this guideline are based on high-/moderate-quality evidence available through March 2022. Focused updates will incorporate future evidence supporting changes to these recommendations.

Published
2022
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6. A new European Society of Anaesthesiology and Intensive Care open access journal

Author

Marc Van de Velde, Esther Pogatzki-Zahn, Anne-Claire Lukaszewicz, Dan Longrois, Tom G. Hansen, Patrice Forget, Michelle S. Chew, Nicolas Bruder, and Charles Marc Samama

Subjects
Access to Information, Anesthesiology and Pain Medicine, Consensus, Science & Technology, Critical Care, Anesthesiology, Humans, Life Sciences & Biomedicine
Abstract

ispartof: EUROPEAN JOURNAL OF ANAESTHESIOLOGY vol:39 issue:5 pages:413-414 ispartof: location:England status: published

Published
2022
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7. Extended anticoagulant treatment with full- or reduced-dose apixaban in patients with cancer-associated venous thromboembolism

Author

Eric Vicaut, Frederikus A. Klok, Charles Marc Samama, Cecilia Becattini, Isabelle Mahé, Alexander T. Cohen, Giancarlo Agnelli, Menno V. Huisman, Sebastian Szmit, D. Mayeur, Peter Verhamme, Marc Philip Righini, Marc Carrier, Tzu-Fei Wang, Manuel Monreal, Kostas N. Syrigos, Adam Torbicki, Juan J. López-Núñez, Cihan Ay, Céline Chapelle, Anthony Maraveyas, Olivier Mir, Aristotelis Bamias, Philippe Girard, Guy Meyer, and Silvy Laporte

Subjects
medicine.medical_specialty, Pyridones, venous thromboembolism, apixaban, Hemorrhage, Internal medicine, Neoplasms, Medicine, Humans, cancer, business.industry, Incidence (epidemiology), Hazard ratio, Cancer, Anticoagulants, Hematology, medicine.disease, Thrombosis, Confidence interval, Pulmonary embolism, Regimen, randomized, Pyrazoles, Apixaban, business, medicine.drug
Abstract

Cancer-associated thrombosis (CT) is associated with a high risk of recurrent venous thromboembolic (VTE) events that require extended anticoagulation in patients with active cancer, putting them at risk of bleeding. The aim of the API-CAT study (NCT03692065) is to assess whether a reduced-dose regimen of apixaban (2.5 mg twice daily [bid]) is noninferior to a full-dose regimen of apixaban (5 mg bid) for the prevention of recurrent VTE in patients with active cancer who have completed ≥6 months of anticoagulant therapy for a documented index event of proximal deep-vein thrombosis and/or pulmonary embolism. API-CAT is an international, randomized, parallel-group, double-blind, noninferiority trial with blinded adjudication of outcome events. Consecutive patients are randomized to receive apixaban 2.5 or 5 mg bid for 12 months. The primary efficacy outcome is a composite of recurrent symptomatic or incidental VTE during the treatment period. The principal safety endpoint is clinically relevant bleeding, defined as a composite of major bleeding or nonmajor clinically relevant bleeding. Assuming a 12-month incidence of the primary outcome of 4% with apixaban and an upper limit of the two-sided 95% confidence interval of the hazard ratio

Published
2021

8. Management of perioperative thromboprophylaxis for surgery following COVID-19: an expert-panel survey

Author

A. Gómez-Luque, Juan V. Llau, Charles-Marc Samama, Arash Afshari, James D. Douketis, and R. Ferrandis

Subjects
Panel survey, 2019-20 coronavirus outbreak, medicine.medical_specialty, Coronavirus disease 2019 (COVID-19), Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), Perioperative Care, Time, Correspondence, Humans, Medicine, perioperative thromboembolism, anticoagulation, Thrombotic risk, SARS-CoV-2, business.industry, Anticoagulants, COVID-19, Venous Thromboembolism, Perioperative, Anesthesiology and Pain Medicine, Perioperative care, Emergency medicine, thromboprophylaxis, business, Venous thromboembolism, thrombotic risk
Published
2021

9. Diagnosis and management of heparin-induced thrombocytopenia

Author

Yves Ozier, F. Mullier, P. Albaladejo, Grégoire Le Gal, Jean-François Schved, Sophie Susen, Jean-Philippe Collet, Emmanuel Marret, Yves Gruel, Jean-François Hardy, Claire Pouplard, N. Blais, D. Lasne, Sylvie Schlumberger, Thomas Lecompte, A. Vincentelli, J.Y. Borg, Brigitte Ickx, A. Godier, Guy Meyer, E de Maistre, Dan Longrois, Samia Madi-Jebara, Sophie Testa, Nathalie Nathan, Mikael Mazighi, André Vincentelli, Joanne Guay, S. Laporte, P.M. Roy, Emmanuel de Maistre, D. Garrigue Huet, P. Zufferey, Y. Huet, Nadia Rosencher, P. Van der Linden, Dominique Lasne, S. Roullet, Y. Gruel, François Mullier, P. Sié, Philippe Nguyen, David Faraoni, Normand Blais, Jerrold H. Levy, Annick Steib, P.E. Morange, S. Lessire, G. Le Gal, Juan V. Llau, Anne Godier, Sylvain Bélisle, Pierre Albaladejo, Serge Motte, Stéphanie Roullet, J.-L. Bosson, Patrick Mismetti, Fanny Bonhomme, Charles-Marc Samama, E. van Belle, J.L. Mas, Pierre Fontana, G. Pernod, S. Susen, A. Borel-Derlon, A. Cohen, UCL - SSS/IREC/MONT - Pôle Mont Godinne, UCL - (MGD) Service d'anesthésiologie, UCL - (MGD) Laboratoire de biologie clinique, Biologie des maladies cardiovasculaires = Biology of Cardiovascular Diseases, and Institut National de la Santé et de la Recherche Médicale (INSERM)-Université de Bordeaux (UB)-Centre National de la Recherche Scientifique (CNRS)

Subjects
medicine.medical_specialty, Clinique, business.industry, MEDLINE, General Medicine, 030204 cardiovascular system & hematology, Critical Care and Intensive Care Medicine, medicine.disease, Gastroenterology, 3. Good health, 03 medical and health sciences, 0302 clinical medicine, Anesthesiology and Pain Medicine, 030220 oncology & carcinogenesis, Heparin-induced thrombocytopenia, Internal medicine, medicine, business, [SDV.MHEP]Life Sciences [q-bio]/Human health and pathology
Abstract

Heparin-induced thrombocytopenia (HIT) is a rare, iatrogenic disease characterised by its potential severity, mainly related to thrombosis, and by difficulties regarding its diagnosis and management of affected patients. In 2002, a conference of experts mobilised by the French Society of Anaesthesia and Intensive Care Medicine (Société française d’anesthésie et de réanimation [SFAR]) drafted recommendations for the management of HIT [...]

Published
2020
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10. Comparative effectiveness of direct oral anticoagulants versus low-molecular weight heparins for the prevention of venous thromboembolism after total hip or knee replacement: A nationwide database cohort study

Author

Régis Lassalle, Simon Lorrain, Stéphanie Lamarque, S. Lignot-Maleyran, Cécile Droz-Perroteau, Patrick Blin, Jacques Benichou, Nicholas Moore, Alain Sautet, Patrick Mismetti, Charles-Marc Samama, CIC Bordeaux, Université Bordeaux Segalen - Bordeaux 2-Institut National de la Santé et de la Recherche Médicale (INSERM), Hôpital Cochin [AP-HP], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP), Université Paris Descartes - Paris 5 (UPD5), CHU Saint-Antoine [AP-HP], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU), CHU Rouen, Normandie Université (NU), Centre Hospitalier Universitaire de Saint-Etienne (CHU de Saint-Etienne), Bordeaux population health (BPH), Université de Bordeaux (UB)-Institut de Santé Publique, d'Épidémiologie et de Développement (ISPED)-Institut National de la Santé et de la Recherche Médicale (INSERM), and CCSD, Accord Elsevier

Subjects
Risk, Male, 0301 basic medicine, medicine.medical_specialty, Databases, Factual, Arthroplasty, Replacement, Hip, medicine.medical_treatment, Total hip replacement, Knee replacement, Effectiveness, Hemorrhage, Cohort Studies, 03 medical and health sciences, 0302 clinical medicine, Internal medicine, Hip replacement, medicine, Humans, Arthroplasty, Replacement, Knee, Aged, Pharmacology, business.industry, Absolute risk reduction, Anticoagulants, Health Care Costs, Venous Thromboembolism, Heparin, Low-Molecular-Weight, Middle Aged, 3. Good health, Total knee replacement, Treatment Outcome, 030104 developmental biology, [SDV.SPEE] Life Sciences [q-bio]/Santé publique et épidémiologie, 030220 oncology & carcinogenesis, Relative risk, Propensity score matching, [SDV.SPEE]Life Sciences [q-bio]/Santé publique et épidémiologie, Female, Venous thromboembolism prevention, France, business, Venous thromboembolism, Cohort study
Abstract

International audience; BACKGROUND: Venous thromboembolism (VTE) after total knee or hip replacement (TKR, THR) is usually prevented with low-molecular weight heparin (LMWH), and increasingly by direct oral anticoagulants (DOAC). The aim of the present study was to compare the benefit-risk and medical costs of DOAC vs. LMWH in a real-life setting. METHODS: All patients with THR or TKR in France between Jan-1st 2013 and Sep-30th 2014, discharged to home, were identified and followed-up for 3 months in the French nationwide claims database, SNDS. DOAC users were 1:1 matched with LWMH users on gender, age and propensity score. Relative risks (RR) of hospitalized VTE, hospitalized bleeding and death were estimated using quasi-Poisson models. Medical costs were calculated according to the societal perspective, including total cost for outpatient claims and national DRG costs for hospitalisations. RESULTS: Most DOAC users (>/= 98.8%) were matched to a LMWH patient. For the 63,238 matched THR patients, the 3-month absolute risk of VTE was 0.9 per thousand with DOAC and 2.5 per thousand with LMWH (RR = 0.35 [0.23 to 0.54]), of bleeding 1.8 per thousand and 2.1 per thousand (0.88 [0.62-1.25]), death 0.7 per thousand and 1.1 per thousand (0.68 [0.40-1.15]). For the 31,440 matched TKR patients, risks were 1.6 per thousand and 2.3 per thousand (0.69 [0.42-1.16]) for VTE, 2.4 per thousand and 3.8 per thousand (0.64 [0.43 to 0.97]) for bleeding, and 0.6 per thousand and 0.8 per thousand (0.69 [0.30-1.62]) for all-cause death. Mean medical costs were 28% and 21% lower with DOAC than LMWH for THR and TKR, respectively. This nationwide study found a very low risk of VTE, hospitalized bleeding and death after THR or TKR discharge in patients with VTE prevention in real-life setting, with better benefit-risk profiles of DOAC compared to LMWH, and associated cost savings.

Published
2019
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11. Stopping or maintaining oral anticoagulation in patients undergoing photoselective vaporization of the prostate (SOAP) surgery for benign prostate obstruction: study protocol for a multicentre randomized controlled trial

Author

L. Corbel, Emmanuel Della Negra, Abdel-Rahmène Azzouzi, Marie Pasquie, Sébastien Vincendeau, Valerie Fuzier, Franck Bruyère, Benoit Peyronnet, Benjamin Pradere, Atul Pathak, Georges Fournier, Aurélien Descazeaud, Thibaut Culty, Hélène Charbonneau, Pierre Albaladejo, Gilles Karsenty, C. Thuillier, Audrey Hesbois, Gaelle Fiard, Jean-Luc Descotes, Souhil Lebdai, C. Ballereau, Nicolas Savy, Nicolas Barry-Delongchamps, J. Calves, Vincent Misrai, Romain Mathieu, Pierre Colin, Charles Marc Samama, Felipe Guerrero, Jean-Alexandre Long, Clinique Pasteur [Toulouse], Service d'urologie [Rennes] = Urology [Rennes], Hôpital Pontchaillou-CHU Pontchaillou [Rennes], Institut Mondor de Recherche Biomédicale (IMRB), Institut National de la Santé et de la Recherche Médicale (INSERM)-IFR10-Université Paris-Est Créteil Val-de-Marne - Paris 12 (UPEC UP12), Service d'urologie [CHU Cochin], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Hôpital Cochin [AP-HP], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP), Hôpital Privé des Côtes d'Armor (HPCA), Chirurgie urologique et transplantation rénale [Hôpital de la Conception - APHM], Aix Marseille Université (AMU)-Assistance Publique - Hôpitaux de Marseille (APHM)-Hôpital de la Conception [CHU - APHM] (LA CONCEPTION), Gestes Medico-chirurgicaux Assistés par Ordinateur (TIMC-IMAG-GMCAO), Techniques de l'Ingénierie Médicale et de la Complexité - Informatique, Mathématiques et Applications, Grenoble - UMR 5525 (TIMC-IMAG), Institut polytechnique de Grenoble - Grenoble Institute of Technology (Grenoble INP )-VetAgro Sup - Institut national d'enseignement supérieur et de recherche en alimentation, santé animale, sciences agronomiques et de l'environnement (VAS)-Centre National de la Recherche Scientifique (CNRS)-Université Grenoble Alpes [2016-2019] (UGA [2016-2019])-Institut polytechnique de Grenoble - Grenoble Institute of Technology (Grenoble INP )-VetAgro Sup - Institut national d'enseignement supérieur et de recherche en alimentation, santé animale, sciences agronomiques et de l'environnement (VAS)-Centre National de la Recherche Scientifique (CNRS)-Université Grenoble Alpes [2016-2019] (UGA [2016-2019]), Service d'urologie [CHU Grenoble], Centre Hospitalier Universitaire [Grenoble] (CHU), Centre Hospitalier Universitaire d'Angers (CHU Angers), PRES Université Nantes Angers Le Mans (UNAM), Service d'urologie [Tours], Centre Hospitalier Régional Universitaire de Tours (CHRU Tours)-Hôpital Bretonneau, Centre Hospitalier Régional Universitaire de Brest (CHRU Brest), AP-HP - Hôpital Cochin Broca Hôtel Dieu [Paris], Laboratoire d'Annecy de Physique des Particules (LAPP), Institut National de Physique Nucléaire et de Physique des Particules du CNRS (IN2P3)-Université Savoie Mont Blanc (USMB [Université de Savoie] [Université de Chambéry])-Centre National de la Recherche Scientifique (CNRS), Institut de Mathématiques de Toulouse UMR5219 (IMT), Université Toulouse Capitole (UT Capitole), Université de Toulouse (UT)-Université de Toulouse (UT)-Institut National des Sciences Appliquées - Toulouse (INSA Toulouse), Institut National des Sciences Appliquées (INSA)-Université de Toulouse (UT)-Institut National des Sciences Appliquées (INSA)-Université Toulouse - Jean Jaurès (UT2J), Université de Toulouse (UT)-Université Toulouse III - Paul Sabatier (UT3), Université de Toulouse (UT)-Centre National de la Recherche Scientifique (CNRS), Techniques pour l'Evaluation et la Modélisation des Actions de la Santé (TIMC-IMAG-ThEMAS), Centre Hospitalier Universitaire de Toulouse (CHU Toulouse), Institut National des Sciences Appliquées - Toulouse (INSA Toulouse), Institut National des Sciences Appliquées (INSA)-Institut National des Sciences Appliquées (INSA)-Université Toulouse 1 Capitole (UT1), Université Fédérale Toulouse Midi-Pyrénées-Université Fédérale Toulouse Midi-Pyrénées-Université Toulouse - Jean Jaurès (UT2J)-Université Toulouse III - Paul Sabatier (UT3), Université Fédérale Toulouse Midi-Pyrénées-Centre National de la Recherche Scientifique (CNRS), CHU Toulouse [Toulouse], Service d'urologie [Rennes], Université de Rennes 1 (UR1), Université de Rennes (UNIV-RENNES)-Université de Rennes (UNIV-RENNES)-Hôpital Pontchaillou-CHU Pontchaillou [Rennes], Centre National de la Recherche Scientifique (CNRS)-Université Toulouse III - Paul Sabatier (UT3), Université Fédérale Toulouse Midi-Pyrénées-Université Fédérale Toulouse Midi-Pyrénées-Université Toulouse - Jean Jaurès (UT2J)-Université Toulouse 1 Capitole (UT1), Université Fédérale Toulouse Midi-Pyrénées-Institut National des Sciences Appliquées - Toulouse (INSA Toulouse), Institut National des Sciences Appliquées (INSA)-Institut National des Sciences Appliquées (INSA), Université Toulouse 1 Capitole (UT1), Université Fédérale Toulouse Midi-Pyrénées-Université Fédérale Toulouse Midi-Pyrénées-Institut National des Sciences Appliquées - Toulouse (INSA Toulouse), Institut National des Sciences Appliquées (INSA)-Université Fédérale Toulouse Midi-Pyrénées-Institut National des Sciences Appliquées (INSA)-Université Toulouse - Jean Jaurès (UT2J)-Université Toulouse III - Paul Sabatier (UT3), and Institut National de la Santé et de la Recherche Médicale (INSERM)-Université Paris-Est Créteil Val-de-Marne - Paris 12 (UPEC UP12)-IFR10

Subjects
Male, medicine.medical_specialty, Time Factors, Complications, medicine.medical_treatment, [SDV]Life Sciences [q-bio], Prostatic Hyperplasia, 030232 urology & nephrology, Oral anticoagulation, Administration, Oral, Medicine (miscellaneous), Laser, Equivalence Trials as Topic, Drug Administration Schedule, law.invention, Study Protocol, 03 medical and health sciences, 0302 clinical medicine, Lower Urinary Tract Symptoms, Randomized controlled trial, law, Prostate, Lower urinary tract symptoms, medicine, Humans, Multicenter Studies as Topic, Pharmacology (medical), Transurethral resection of the prostate, lcsh:R5-920, business.industry, Anticoagulants, GreenLight, Perioperative, Evidence-based medicine, Heparin, medicine.disease, Confidence interval, 3. Good health, Surgery, Treatment Outcome, medicine.anatomical_structure, 030220 oncology & carcinogenesis, France, Laser Therapy, Benign prostatic obstruction, lcsh:Medicine (General), business, medicine.drug
Abstract

Lower urinary tract symptoms related to benign prostatic obstruction (BPO) are frequent in men aged > 50 years. Based on the use of innovative medical devices, a number of transurethral ablative techniques have recently been developed for the surgical treatment of BPO. In recent years, GreenLight photoselective vaporization of the prostate (PVP) has been considered as a non-inferior alternative to transurethral resection of the prostate. The GreenLight PVP is usually considered as an interesting surgical option for patients treated via oral anticoagulants (OACs) with regard to its haemostatic properties. The aim of this study was to assess the impact of maintaining OAC treatment in patients undergoing PVP. This study is a multicentre, open-label, randomized controlled trial (RCT) designed to show the non-inferiority of PVP surgery in patients with BPO treated with OACs. This study is designed to enrol 386 OAC-treated patients (treated with vitamin K antagonists and direct oral anticoagulants) who are undergoing PVP for BPO. Patients will be randomized (1:1) to either maintain or stop OAC treatment during the perioperative course. The intervention group will maintain OAC treatment until the day before surgery and resume OAC treatment the day after surgery, whereas the control group will stop OAC treatment (with or without low-molecular-weight heparin bridging therapy) according to the anaesthesia guidelines. The primary outcome of interest to be assessed is the 30-day complications rate according to the Clavien-Dindo classification. The secondary endpoint will examine the 30-day rate of haemorrhagic and thrombotic events. This study will provide 80% power to show non-inferiority, defined as not worse than a 10% (non-inferiority margin) inferior change in the proportion of patients with good outcomes (Clavien-Dindo score

Published
2018
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12. Aprotinin: is it time to reconsider?

Author

Jan van der Linden, Jens Meier, Christian von Heyman, Stefan De Hert, Juan V. Llau, Marcus D. Lancé, Philippe Pouard, Ravi Gill, Charles-Marc Samama, Walid Habre, Philippe Van der Linden, Anesthesiology, RS: CARIM - R1 - Thrombosis and haemostasis, Anesthesiologie, and Intensive Care

Subjects
medicine.medical_specialty, Serine Proteinase Inhibitors, Whole Blood Coagulation Time, Preoperative Care/adverse effects/methods, Postoperative Hemorrhage, law.invention, Aprotinin, law, Serine Proteinase Inhibitors/administration & dosage/adverse effects, Preoperative Care, medicine, Cardiopulmonary bypass, Humans, Postoperative Hemorrhage/chemically induced/prevention & control, Aprotinin/administration & dosage/adverse effects, business.industry, Surgery, Whole Blood Coagulation Time/methods, Epsilon-Aminocaproic Acid, Anesthesiology and Pain Medicine, Cardiothoracic surgery, Anesthesia, business, Tranexamic acid, medicine.drug
Published
2015
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13. Management of severe perioperative bleeding: guidelines from the European Society of Anaesthesiology: First update 2016

Author

Niels Rahe-Meyer, Patrick Wouters, Cesar Aldecoa, Matthias Jacob, Charles Marc Samama, Guidrius Barauskas, Juan V.L. Pitarch, Anne Wikkelsø, Arash Afshari, Pierre Albaladejo, Sibylle A. Kozek-Langenecker, Kai Zacharowski, David Faraoni, Jakob Stensballe, Piet Wyffels, Edoardo De Robertis, Dietmar Fries, Thorsten Haas, Philippe Van der Linden, Zsolt Molnár, Marcus D. Lancé, Jens Meier, Susan Mallett, Daniela Filipescu, Aamer B Ahmed, University of Zurich, and Kozek-Langenecker, Sibylle A

Subjects
medicine.medical_specialty, business.industry, MEDLINE, 610 Medicine & health, Perioperative, 030204 cardiovascular system & hematology, medicine.disease, Patient care, law.invention, 03 medical and health sciences, 0302 clinical medicine, Increased risk, Anesthesiology and Pain Medicine, Randomized controlled trial, law, Activated factor VII, Emergency medicine, medicine, Von Willebrand disease, 030212 general & internal medicine, 10220 Clinic for Surgery, 2703 Anesthesiology and Pain Medicine, Intensive care medicine, business, PROTHROMBIN COMPLEX
Abstract

The management of perioperative bleeding involves multiple assessments and strategies to ensure appropriate patient care. Initially, it is important to identify those patients with an increased risk of perioperative bleeding. Next, strategies should be employed to correct preoperative anaemia and to

Published
2017

14. Research ethics committee approval as reported for abstracts submitted to the annual Euroanaesthesia meeting

Author

Charles Marc Samama, Paul McConnell, Stefan De Hert, Nechama Kaufman, Zsolt Molnár, Sharon Einav, and Anesthesiology

Subjects
Research Report, medicine.medical_specialty, Abstracting and Indexing, education, MEDLINE, 0603 philosophy, ethics and religion, 03 medical and health sciences, 0302 clinical medicine, Informed consent, Medicine, Humans, Anesthesia, 030212 general & internal medicine, Societies, Medical, Research ethics, business.industry, Ethics committee, 06 humanities and the arts, Congresses as Topic, Europe, Anesthesiology and Pain Medicine, Family medicine, 060301 applied ethics, business, Medical ethics, Ethics Committees, Research
Abstract

The annual congress of the European Society of Anaesthesiology (ESA) is one of the largest anaesthesia congresses in the world and exhibits more than 1200 abstracts annually. The aims of this study were to quantify the frequency of inadequate evidence of ethical approval for abstracts submitted to the ESA congress and to examine whether abstracts without appropriate ethical approval were subsequently accepted. All abstracts submitted in 2015 were adjudicated according to European ethical criteria. The proportion of submitted abstracts that lacked evidence of appropriate ethics committee approval. Secondary outcomes included the proportion of accepted abstract that lacked evidence of appropriate ethical approval; the proportion of correctly identified case reports; the proportion of accepted abstracts that lacked evidence of appropriate ethics committee approvals corresponding to location (within/outside Europe); and the proportion of accepted abstracts that lacked evidence of appropriate ethics committee approvals corresponding to a specific area of research. In total, 1792 abstracts were reviewed and 1572 (87.7%) involved humans. In 527 (29.4%), the authors failed to demonstrate adequate ethical approval with higher rates in abstracts submitted from Europe (32.1%) than the rest of the world (23.5%), P

Published
2017

15. Dabigatran etexilate for thromboprophylaxis in over 5000 hip or knee replacement patients in a real-world clinical setting

Author

Nadia Rosencher, Andreas Clemens, Martina Brueckmann, Charles Marc Samama, Eva Kleine, Martin Feuring, and Simon P. Frostick

Subjects
medicine.medical_specialty, medicine.medical_treatment, Dabigatran etexilate, Knee replacement, 030204 cardiovascular system & hematology, Dabigatran, 03 medical and health sciences, 0302 clinical medicine, Internal medicine, Observational study, medicine, 030212 general & internal medicine, Summary of Product Characteristics, Thromboprophylaxis, Angiology, business.industry, Incidence (epidemiology), Total hip replacement, Odds ratio, Hematology, Confidence interval, Surgery, Total knee replacement, Original Clinical Investigation, business, medicine.drug
Abstract

Background Thromboprophylaxis is recommended for patients undergoing total hip or total knee replacement (THR, TKR). An international, open-label, prospective, observational, single-arm study in a routine clinical setting was performed to assess the safety and efficacy of dabigatran etexilate 220 mg once daily in patients undergoing THR or TKR, and in subgroups of patients with potentially increased risk of bleeding or venous thromboembolism (VTE). Materials and methods Patients were ≥18 years and required to be eligible to receive dabigatran 220 mg once daily (first dose 110 mg 1–4 h after THR/TKR surgery) according to the European Summary of Product Characteristics. The primary safety and efficacy outcomes were incidence of major bleeding events (MBEs), and the composite incidence of symptomatic VTE events and all-cause mortality, respectively. Results In total, 5292 patients (median age 64 years) were enrolled and received dabigatran (2734 THR and 2558 TKR). Median drug exposure was 31 days (THR 34 days; TKR 27 days). Overall incidence of MBEs was 0.72 % (95 % confidence interval [CI] 0.51, 0.98), and this rate was comparable between types of surgery and was not significantly affected by protocol-defined risk factors. The overall incidence of symptomatic VTE and all-cause mortality was 1.04 % (95 % CI 0.78, 1.35); the only significant risk factor was history of VTE events (odds ratio 5.59; 95 % CI 2.53, 11.08). A post-hoc analysis showed that the incidence of MBEs in this observational study was similar to or lower than those reported in previous phase 3 trials. Conclusions Results from this observational study of dabigatran etexilate administered to patients undergoing THR or TKR surgery are reassuring and supportive of those obtained in dabigatran phase 3 trials. Trial registration ClinicalTrials.gov identifier: NCT00846807. Electronic supplementary material The online version of this article (doi:10.1186/s12959-016-0082-4) contains supplementary material, which is available to authorized users.

Published
2016

16. Management of severe perioperative bleeding

Author

Sibylle A. Kozek Langenecker, Arash Afshari, Pierre Albaladejo, Cesar Aldecoa Alvarez Santullano, Daniela C. Filipescu, Dietmar Fries, Klaus G?rlinger, Thorsten Haas, Georgina Imberger, Matthias Jacob, Marcus Lanc?, Juan Llau, Sue Mallett, Jens Meier, Niels Rahe Meyer, Charles Marc Samama, Andrew Smith, Cristina Solomon, Philippe Van der Linden, Anne Juul Wikkels?, Patrick Wouters, Piet Wyffels, DE ROBERTIS, EDOARDO, Sibylle A., Kozek Langenecker, Arash, Afshari, Pierre, Albaladejo, Cesar Aldecoa Alvarez, Santullano, DE ROBERTIS, Edoardo, Daniela C., Filipescu, Dietmar, Frie, Klaus, G?rlinger, Thorsten, Haa, Georgina, Imberger, Matthias, Jacob, Marcus, Lanc?, Juan, Llau, Sue, Mallett, Jens, Meier, Niels Rahe, Meyer, Charles Marc, Samama, Andrew, Smith, Cristina, Solomon, Philippe Van der, Linden, Anne Juul, Wikkels?, Patrick, Wouter, and Piet, Wyffels

Published
2013

17. Venous thromboembolism prophylaxis in patients undergoing abdominal or pelvic surgery for cancer--a real-world, prospective, observational French study: PRéOBS

Author

Yves Gruel, Christophe Mariette, Pascal Rischmann, Philippe Debourdeau, Dominique Mottier, P. Coloby, Léon Boubli, Laurent Toubiana, Charles-Marc Samama, Annick Steib, Laboratoire d'Informatique Médicale et Ingénierie des Connaissances en e-Santé (LIMICS), Université Paris 13 (UP13)-Université Pierre et Marie Curie - Paris 6 (UPMC)-Institut National de la Santé et de la Recherche Médicale (INSERM), Service d'Anesthésie-Réanimation (COCHIN - Anesthésie-Réanimation), Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Université Paris Descartes - Paris 5 (UPD5), Service de Gynécologie-Obstétrique (MARSEILLE - Gynéco-Obs), CHU Marseille- Hôpital Nord [CHU - APHM], Service d'urologie [CH René Dubos Pontoise], Centre Hospitalier René Dubos [Pontoise], Service d'Hématologie (HIA LYON - Hématologie), HIA Desgenettes LYON, Génétique, immunothérapie, chimie et cancer (GICC), UMR 7292 CNRS [2012-2017] (GICC UMR 7292 CNRS), Université de Tours (UT)-Centre National de la Recherche Scientifique (CNRS), Centre de Recherche Jean-Pierre AUBERT Neurosciences et Cancer - U837 (JPArc), Université Lille Nord de France (COMUE)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Université de Lille, 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 National de la Santé et de la Recherche Médicale (INSERM)-Institut Brestois Santé Agro Matière (IBSAM), Université de Brest (UBO)-Université de Brest (UBO), Département d'Urologie-Andrologie et Transplantation Rénale [CHU Toulouse], Pôle Urologie - Néphrologie - Dialyse - Transplantations - Brûlés - Chirurgie plastique - Explorations fonctionnelles et physiologiques [CHU Toulouse], Centre Hospitalier Universitaire de Toulouse (CHU Toulouse)-Centre Hospitalier Universitaire de Toulouse (CHU Toulouse), UPRES EA 222, Université Paris Descartes - Paris 5 (UPD5), EA 4067 (EA 4067), CHU Necker - Enfants Malades [AP-HP], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP), Service d'Anesthésie-Réanimation (TP - SAR), CHU Strasbourg, Université de Tours-Centre National de la Recherche Scientifique (CNRS), Centre de Recherche Jean-Pierre AUBERT Neurosciences et Cancer - U1172 Inserm - U837 (JPArc), Institut National de la Santé et de la Recherche Médicale (INSERM)-Université Lille Nord de France (COMUE)-Université de Lille, Université de Brest (UBO)-Institut Brestois Santé Agro Matière (IBSAM), Service d'Urologie - Transplantation Rénale - Andrologie, CHU Toulouse [Toulouse]-Hôpital de Rangueil, CHU Toulouse [Toulouse], Assistance publique - Hôpitaux de Paris (AP-HP) (APHP)-Université Paris Descartes - Paris 5 (UPD5), Centre de Recherche Jean-Pierre AUBERT Neurosciences et Cancer (JPArc - U837 Inserm), Institut National de la Santé et de la Recherche Médicale (INSERM)-Centre Hospitalier Régional Universitaire [Lille] (CHRU Lille)-Université Lille 2 - Faculté de Médecine, Université de Brest (UBO), Toubiana, Laurent, Service d'Anesthésie-Réanimation ( COCHIN - Anesthésie-Réanimation ), Assistance publique - Hôpitaux de Paris (AP-HP)-Université Paris Descartes - Paris 5 ( UPD5 ), Service de Gynécologie-Obstétrique ( MARSEILLE - Gynéco-Obs ), Service d'Hématologie ( HIA LYON - Hématologie ), Génétique, Immunothérapie, Chimie et Cancer ( GICC ), Université de Tours-Centre National de la Recherche Scientifique ( CNRS ), Centre de recherche Jean-Pierre Aubert-Neurosciences et Cancer, Institut National de la Santé et de la Recherche Médicale ( INSERM ) -Université de Lille, Droit et Santé, 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 ), Université Paris Descartes - Paris 5 ( UPD5 ), EA 4067 ( EA 4067 ), and Service d'Anesthésie-Réanimation ( TP - SAR )

Subjects
Male, medicine.medical_specialty, Epidemiology, [SDV]Life Sciences [q-bio], 030204 cardiovascular system & hematology, Pelvis, Cohort Studies, Real-world observational study, 03 medical and health sciences, 0302 clinical medicine, Risk Factors, Neoplasms, Abdominal or pelvic cancer surgery, Abdomen, Antithrombotic, Humans, Medicine, In patient, Prospective Studies, Thromboprophylaxis, [INFO.INFO-BI] Computer Science [cs]/Bioinformatics [q-bio.QM], Aged, Randomized Controlled Trials as Topic, [ SDV ] Life Sciences [q-bio], business.industry, Incidence (epidemiology), Cancer, Hematology, Perioperative, Middle Aged, medicine.disease, 3. Good health, Surgery, Surgical Procedures, Operative, 030220 oncology & carcinogenesis, Female, Observational study, France, [INFO.INFO-BI]Computer Science [cs]/Bioinformatics [q-bio.QM], business, Venous thromboembolism
Abstract

Introduction Data on the epidemiology and prevention of venous thromboembolism in patients undergoing abdominal or pelvic cancer surgery in real practice are limited. The primary objective of this observational study was to describe the thromboprophylactic strategy implemented in routine practice. The main secondary objective was to assess the incidence of outcomes. Materials and Methods Patients admitted to public or private hospitals for abdominal or pelvic cancer surgery were included between November 2009 and November 2010; endoscopic route for surgery was the only exclusion criterion. Study outcomes were recorded at hospital discharge and at routine follow-up (generally 9 ± 3 weeks). Results 2380 patients (mean ± SD age: 66.4 ± 11.6 years, women: 36.8%) admitted to hospital for abdominal (47.8%), urological (41%), or gynaecological (11.2%) cancer surgery were included in the analysis. Of these, 2179 had data available at study end. Perioperative antithrombotic prophylaxis, consisting mainly of low-molecular-weight heparin, was given to 99.5% of patients. At hospital discharge, thromboprophylaxis was continued in 91.7% of patients, 57.4% receiving a 4-6 week prophylaxis. This management strategy was associated with an overall venous thromboembolic event rate of 1.9%, 34.7% of events occurring after discharge. Incidences of fatal bleeding, bleeding in a critical organ and bleeding necessitating re-intervention were 0.1%, 0.3% and 1.7%, respectively. Overall mortality was 1.5%. Conclusions Thromboprophylaxis is routinely used in French patients undergoing major cancer surgery. For more than a third of patients, however, treatment duration did not comply with best-practice recommendations, which might explain the non-negligible rate of thromboembolic complications still observed in this patient population.

Published
2014
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18. Guideline-concordant administration of prothrombin complex concentrate and vitamin K is associated with decreased mortality in patients with severe bleeding under vitamin K antagonist treatment (EPAHK study)

Author

Karim, Tazarourte, Bruno, Riou, Benjamin, Tremey, Charles-Marc, Samama, Eric, Vicaut, Bernard, Vigué, Arnaud, Delahaye, Service d'Aide Médicale Urgente 77 (SAMU 77), Centre hospitalier Marc Jacquet (Melun), Unité de Recherche sur les Maladies Cardiovasculaires, du Métabolisme et de la Nutrition = Research Unit on Cardiovascular and Metabolic Diseases (ICAN), Université Pierre et Marie Curie - Paris 6 (UPMC)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Institut National de la Santé et de la Recherche Médicale (INSERM)-CHU Pitié-Salpêtrière [AP-HP], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU)-Sorbonne Université (SU), Service d'Anesthésie Réanimation [Ambroise Paré], Clinique Ambroise Paré, Service d'Anesthésie et de Soins Intensifs, Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Hôpital Cochin [AP-HP], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Hôtel-Dieu-Université Paris Descartes - Paris 5 (UPD5), Service de Statistiques, Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Hôpital Lariboisière-Fernand-Widal [APHP], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Université Paris Diderot - Paris 7 (UPD7), Service d'Anesthésie et de Soins Intensifs [Bicêtre], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Hôpital Bicêtre, EPAHK study group, Service d'Aide Médicale Urgente 77 ( SAMU 77 ), Unité de Recherche sur les Maladies Cardiovasculaires, du Métabolisme et de la Nutrition = Institute of cardiometabolism and nutrition ( ICAN ), Université Pierre et Marie Curie - Paris 6 ( UPMC ) -Assistance publique - Hôpitaux de Paris (AP-HP)-Institut National de la Santé et de la Recherche Médicale ( INSERM ) -CHU Pitié-Salpêtrière [APHP], Assistance publique - Hôpitaux de Paris (AP-HP)-CHU Cochin [AP-HP]-Hôtel-Dieu-Université Paris Descartes - Paris 5 ( UPD5 ), Assistance publique - Hôpitaux de Paris (AP-HP)-Hôpital Lariboisière-Université Paris Diderot - Paris 7 ( UPD7 ), Assistance publique - Hôpitaux de Paris (AP-HP)-Hôpital Bicêtre, Unité de Recherche sur les Maladies Cardiovasculaires, du Métabolisme et de la Nutrition = Institute of cardiometabolism and nutrition (ICAN), Sorbonne Université (SU)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU), and BMC, Ed.

Subjects
Male, Vitamin, medicine.medical_specialty, Vitamin K, [SDV.MHEP.PHY] Life Sciences [q-bio]/Human health and pathology/Tissues and Organs [q-bio.TO], medicine.drug_class, Hemorrhage, 030204 cardiovascular system & hematology, Critical Care and Intensive Care Medicine, Gastroenterology, Cohort Studies, 03 medical and health sciences, chemistry.chemical_compound, 0302 clinical medicine, Internal medicine, medicine, [SDV.MHEP.PHY]Life Sciences [q-bio]/Human health and pathology/Tissues and Organs [q-bio.TO], Humans, Prospective Studies, Mortality, Prospective cohort study, Aged, Aged, 80 and over, business.industry, [ SDV.MHEP.PHY ] Life Sciences [q-bio]/Human health and pathology/Tissues and Organs [q-bio.TO], Research, 030208 emergency & critical care medicine, Odds ratio, Guideline, Middle Aged, Vitamin K antagonist, Prothrombin complex concentrate, Blood Coagulation Factors, 3. Good health, Surgery, Treatment Outcome, chemistry, Practice Guidelines as Topic, Cohort, Drug Therapy, Combination, Female, business, medicine.drug, Cohort study
Abstract

Introduction: In vitamin K antagonist (VKA)-treated patients with severe hemorrhage, guidelines recommend prompt VKA reversal with prothrombin complex concentrate (PCC) and vitamin K. The aim of this observational cohort study was to evaluate the impact of guideline concordant administration of PCC and vitamin K on seven-day mortality. Methods: Data from consecutive patients treated with PCC were prospectively collected in 44 emergency departments. Type of hemorrhage, coagulation parameters, type of treatment and seven-day mortality mortality were recorded. Guideline-concordant administration of PCC and vitamin K (GC-PCC-K) were defined by at least 20 IU/kg factor IX equivalent PCC and at least 5 mg of vitamin K performed within a predefined time frame of eight hours after admission. Multivariate analysis was used to assess the effect of appropriate reversal on seven-day mortality in all patients and in those with intracranial hemorrhage (ICH). Results: Data from 822 VKA-treated patients with severe hemorrhage were collected over 14 months. Bleeding was gastrointestinal (32%), intracranial (32%), muscular (13%), and “other” (23%). In the whole cohort, seven-day mortality was 13% and 33% in patients with ICH. GC-PCC-K was performed in 38% of all patients and 44% of ICH patients. Multivariate analysis showed a two-fold decrease in seven-day mortality in patients with GC-PCC-K (odds ratio (OR) = 2.15 (1.20 to 3.88); P = 0.011); this mortality reduction was also observed when only ICH was considered (OR = 3.23 (1.53 to 6.79); P = 0.002). Conclusions: Guideline-concordant VKA reversal with PCC and vitamin K within eight hours after admission was associated with a significant decrease in seven-day mortality.

Published
2014
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19. Management of major bleeding complications and emergency surgery in patients on long-term treatment with direct oral anticoagulants, thrombin or factor-Xa inhibitors: Proposals of the Working Group on Perioperative Haemostasis (GIHP) - March 2013

Author

Normand Blais, Meyer Michel Samama, Sophie Susen, Patrick Mismetti, Juan V. Llau, Ariel Cohen, Anne Godier, Yves Gruel, Emmanuel de Maistre, Pierre Sié, Gilles Pernod, Nadia Rosencher, Charles Marc Samama, Pierre Fontana, P. Albaladejo, and Jean-François Schved

Subjects
Prothrombin time, ddc:616, Rivaroxaban, medicine.diagnostic_test, medicine.drug_class, business.industry, Anticoagulant, General Medicine, Vitamin K antagonist, Prothrombin complex concentrate, Dabigatran, chemistry.chemical_compound, chemistry, Edoxaban, Anesthesia, medicine, Apixaban, Cardiology and Cardiovascular Medicine, business, medicine.drug
Abstract

Direct new oral anticoagulants (NOACs) - inhibitors of thrombin or factor Xa - are intended to be used largely in the treatment of venous thromboembolic disease or the prevention of systematic embolism in atrial fibrillation, instead of vitamin K antagonists. Like any anticoagulant treatment, they are associated with spontaneous or provoked haemorrhagic risk. Furthermore, a significant proportion of treated patients are likely to be exposed to emergency surgery or invasive procedures. Given the absence of a specific antidote, the action to be taken in these situations must be defined. The lack of data means that it is only possible to issue proposals rather than recommendations, which will evolve according to accumulated experience. The proposals presented here apply to dabigatran (Pradaxa(®)) and rivaroxaban (Xarelto(®)); data for apixaban and edoxaban are still scarce. For urgent surgery with haemorrhagic risk, the drug plasma concentration should be less or equal to 30ng/mL for dabigatran and rivaroxaban should enable surgery associated with a high bleeding risk. Beyond that, if possible, the intervention should be postponed by monitoring the drug concentration. The course to follow is then defined according to the NOAC and its concentration. If the anticoagulant dosage is not immediately available, worse propositions, based on the usual tests (prothrombin time and activated partial thromboplastin time), are presented. However, these tests do not really assess drug concentration or the risk of bleeding that depends on it. In case of serious bleeding in a critical organ, the effect of anticoagulant therapy should be reduced using a non-specific procoagulant drug as a first-line approach: activated prothrombin complex concentrate (aPCC) (FEIBA(®) 30-50U/kg) or non-activated PCC (50U/kg). In addition, for any other type of severe haemorrhage, the administration of a procoagulant drug, which is potentially thrombogenic in these patients, is discussed according to the NOAC concentration and the possibilities of mechanical haemostasis.

Published
2013

20. Pharmacokinetics of fondaparinux 1.5 mg once daily in a real-world cohort of patients with renal impairment undergoing major orthopaedic surgery

Author

Xavier, Delavenne, Paul, Zufferey, Philippe, Nguyen, Nadia, Rosencher, Charles-Marc, Samama, Céline, Bazzoli, Patrick, Mismetti, Silvy, Laporte, T, Garanger, Groupe de recherche sur la thrombose (GRT (EA 3065)), Université Jean Monnet [Saint-Étienne] (UJM), Hôpital Robert Debré Paris, Hôpital Robert Debré, Hôpital Cochin [AP-HP], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP), Service d'anesthésie-réanimation [Hôtel-Dieu], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Hôpital Hôtel-Dieu [Paris], Statistique Apprentissage Machine (SAM), Laboratoire Jean Kuntzmann (LJK), Université Pierre Mendès France - Grenoble 2 (UPMF)-Université Joseph Fourier - Grenoble 1 (UJF)-Institut polytechnique de Grenoble - Grenoble Institute of Technology (Grenoble INP )-Centre National de la Recherche Scientifique (CNRS)-Université Pierre Mendès France - Grenoble 2 (UPMF)-Université Joseph Fourier - Grenoble 1 (UJF)-Institut polytechnique de Grenoble - Grenoble Institute of Technology (Grenoble INP )-Centre National de la Recherche Scientifique (CNRS), Modèles et méthodes de l'évaluation thérapeutique des maladies chroniques (U738 / UMR_S738), Institut National de la Santé et de la Recherche Médicale (INSERM)-Université Paris Diderot - Paris 7 (UPD7), Groupe de recherche sur la thrombose ( GRT (EA 3065) ), Université Jean Monnet [Saint-Étienne] ( UJM ), CHU Cochin [AP-HP], Assistance publique - Hôpitaux de Paris (AP-HP)-Hôpital Hôtel-Dieu [Paris], SAM, Modèles et méthodes de l'évaluation thérapeutique des maladies chroniques, Université Paris Diderot - Paris 7 ( UPD7 ) -Institut National de la Santé et de la Recherche Médicale ( INSERM ) -Université Paris Diderot - Paris 7 ( UPD7 ) -Institut National de la Santé et de la Recherche Médicale ( INSERM ) -Laboratoire Jean Kuntzmann ( LJK ), and Université Pierre Mendès France - Grenoble 2 ( UPMF ) -Université Joseph Fourier - Grenoble 1 ( UJF ) -Institut Polytechnique de Grenoble - Grenoble Institute of Technology-Centre National de la Recherche Scientifique ( CNRS ) -Université Grenoble Alpes ( UGA ) -Université Pierre Mendès France - Grenoble 2 ( UPMF ) -Université Joseph Fourier - Grenoble 1 ( UJF ) -Institut Polytechnique de Grenoble - Grenoble Institute of Technology-Centre National de la Recherche Scientifique ( CNRS ) -Université Grenoble Alpes ( UGA )

Subjects
Male, Simulations, medicine.medical_specialty, Orthopaedic surgery, Urology, Renal function, 030204 cardiovascular system & hematology, Kidney, Fondaparinux, Drug Administration Schedule, Cohort Studies, 03 medical and health sciences, chemistry.chemical_compound, 0302 clinical medicine, Pharmacokinetics, Polysaccharides, [MATH.MATH-ST]Mathematics [math]/Statistics [math.ST], medicine, Humans, Orthopedic Procedures, Pharmacology (medical), Renal Insufficiency, [ MATH.MATH-ST ] Mathematics [math]/Statistics [math.ST], 030212 general & internal medicine, Renal impairment, Aged, Aged, 80 and over, Pharmacology, business.industry, Factor X, Anticoagulants, Venous Thromboembolism, General Medicine, [STAT.TH]Statistics [stat]/Statistics Theory [stat.TH], [ STAT.TH ] Statistics [stat]/Statistics Theory [stat.TH], 3. Good health, NONMEM, Regimen, chemistry, Area Under Curve, Anesthesia, Orthopedic surgery, Cohort, Female, business, Factor Xa Inhibitors, medicine.drug
Abstract

International audience; Purpose Fondaparinux, a selective activator factor X (factor Xa) inhibitor, is effective and safe for preventing venous thromboembolism after major orthopaedic surgery (MOS) at the once-daily subcutaneous dose of 2.5 mg. As the drug is mainly eliminated by the kidneys, a reduced dosage (1.5 mg once daily) was developed for patients with renal impairment. Methods We studied the pharmacokinetics (PK) of this dosage regimen using data from a real-world cohort of 442 patients with renal impairment (creatinine clearance 20-50 ml/min) undergoing MOS. Data were analysed using NON-linear Mixed Effect Modelling software (NONMEM) software. Fondaparinux PK was modelled using a two-compartment model with first-order absorption. Results This analysis confirmed the relationship between renal function and fondaparinux PK profiles. The mean predicted steady-state area under the plasma concentration time curve, peak and trough plasma concentrations of fondaparinux were lower by 15.6 %, 13.0 % and 10.3 %, respectively, in patients with renal impairment treated with 1.5 mg compared with patients with normal renal function treated with 2.5 mg (p Conclusion Although administration of 1.5 mg fondaparinux in patients with renal impairment resulted in a predicted exposure slightly lower than that achieved with 2.5 mg in patients with normal renal function, fondaparinux 1.5 mg is a valuable thromboprophylactic option in MOS patients with renal impairment who are at risk of bleeding.

Published
2012
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21. Delphi-Consensus Weights for Ischemic and Bleeding Events to Be Included in a Composite Outcome for RCTs in Thrombosis Prevention

Author

Charles Marc Samama, Florence Tubach, Pierre Albaladejo, Agnès Dechartres, Philippe Gabriel Steg, Philippe Ravaud, Jean-Philippe Collet, and Jean Mantz

Subjects
SELECTION, Non-Clinical Medicine, medicine.medical_treatment, Health Care Providers, General Anesthesia, Embolectomy, lcsh:Medicine, 030204 cardiovascular system & hematology, 0302 clinical medicine, Anesthesiology, Ischemia, Pathology, Medicine, 030212 general & internal medicine, lcsh:Science, Hematopathology, Randomized Controlled Trials as Topic, Multidisciplinary, Hematology, Qualitative Studies, Research Assessment, Thrombosis, 3. Good health, Pulmonary embolism, Stroke, Venous thrombosis, Treatment Outcome, Quartile, Perioperative Hemostasis, Neurology, CARDIOVASCULAR TRIALS, Science & Technology - Other Topics, CLINICAL-TRIALS, Research Article, Platelets, medicine.medical_specialty, Drugs and Devices, Clinical Pathology, Clinical Research Design, Science Policy, General Science & Technology, Cerebrovascular Diseases, Specialty, Hemorrhage, 03 medical and health sciences, Cronbach's alpha, Adverse Reactions, Diagnostic Medicine, Internal medicine, Physicians, END-POINTS, BENEFITS, MD Multidisciplinary, Humans, Clinical Trials, Ischemic Stroke, Intracerebral hemorrhage, Science & Technology, Coagulation Disorders, Aspirin, business.industry, MULTIDISCIPLINARY SCIENCES, lcsh:R, medicine.disease, RANDOMIZED-TRIALS, Surgery, ALPHA, THROMBOLYTIC THERAPY, lcsh:Q, business
Abstract

Background and Objectives To weight ischemic and bleeding events according to their severity to be used in a composite outcome in RCTs in the field of thrombosis prevention. Method Using a Delphi consensus method, a panel of anaesthesiology and cardiology experts rated the severity of thrombotic and bleeding clinical events. The ratings were expressed on a 10-point scale. The median and quartiles of the ratings of each item were returned to the experts. Then, the panel members evaluated the events a second time with knowledge of the group responses from the first round. Cronbach's a was used as a measure of homogeneity for the ratings. The final rating for each event corresponded to the median rating obtained at the last Delphi round. Results Of 70 experts invited, 32 (46%) accepted to participate. Consensus was reached at the second round as indicated by Cronbach's a value (0.99 (95% CI 0.98-1.00)) so the Delphi was stopped. Severity ranged from under-popliteal venous thrombosis (median = 3, Q1 = 2; Q3 = 3) to ischemic stroke or intracerebral hemorrhage with severe disability at 7 days and massive pulmonary embolism (median = 9, Q1 = 9; Q3 = 9). Ratings did not differ according to the medical specialty of experts. Conclusions These ratings could be used to weight ischemic and bleeding events of various severity comprising a composite outcome in the field of thrombosis prevention.

Published
2011

22. Incidence and risk factors for venous thromboembolism in patients with nonsurgical isolated lower limb injuries

Author

Charles Marc Samama, Moussa Hamadouche, Bruno Riou, Jean-Luc Bosson, Nathalie Lecoules, Eric Bouvat, Christophe Rothmann, Philipe Ravaud, CHU Pitié-Salpêtrière [AP-HP], Sorbonne Université (SU)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP), ThEMAS, Techniques de l'Ingénierie Médicale et de la Complexité - Informatique, Mathématiques et Applications, Grenoble - UMR 5525 (TIMC-IMAG), VetAgro Sup - Institut national d'enseignement supérieur et de recherche en alimentation, santé animale, sciences agronomiques et de l'environnement (VAS)-Institut polytechnique de Grenoble - Grenoble Institute of Technology (Grenoble INP )-Centre National de la Recherche Scientifique (CNRS)-Université Joseph Fourier - Grenoble 1 (UJF)-VetAgro Sup - Institut national d'enseignement supérieur et de recherche en alimentation, santé animale, sciences agronomiques et de l'environnement (VAS)-Institut polytechnique de Grenoble - Grenoble Institute of Technology (Grenoble INP )-Centre National de la Recherche Scientifique (CNRS)-Université Joseph Fourier - Grenoble 1 (UJF)-CIC - Grenoble, Université Joseph Fourier - Grenoble 1 (UJF)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Institut National de la Santé et de la Recherche Médicale (INSERM), Département d'épidémiologie, biostatistique et recherche clinique, Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-AP-HP - Hôpital Bichat - Claude Bernard [Paris], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP), Modèles et méthodes de l'évaluation thérapeutique des maladies chroniques (U738 / UMR_S738), Institut National de la Santé et de la Recherche Médicale (INSERM)-Université Paris Diderot - Paris 7 (UPD7), Service d'anesthésie-réanimation [Hôtel-Dieu], Hôpital Hôtel-Dieu [Paris], and Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)

Subjects
Male, MESH: Leg Injuries, MESH: Pulmonary Embolism, 030204 cardiovascular system & hematology, 0302 clinical medicine, MESH: Aged, 80 and over, Risk Factors, MESH: Risk Factors, Prospective Studies, 030212 general & internal medicine, MESH: Incidence, Prospective cohort study, Ultrasonography, Aged, 80 and over, Venous Thrombosis, MESH: Aged, MESH: Statistics, Nonparametric, MESH: Middle Aged, Incidence, Incidence (epidemiology), General Medicine, Middle Aged, 3. Good health, Pulmonary embolism, MESH: Leg, Venous thrombosis, MESH: Thromboembolism, Emergency Medicine, Female, France, medicine.symptom, Adult, medicine.medical_specialty, Adolescent, Asymptomatic, Statistics, Nonparametric, Immobilization, 03 medical and health sciences, Thromboembolism, Intensive care, Internal medicine, medicine, Humans, cardiovascular diseases, Risk factor, Aged, MESH: Adolescent, [SDV.EE.SANT]Life Sciences [q-bio]/Ecology, environment/Health, Leg, MESH: Humans, business.industry, MESH: Adult, Odds ratio, medicine.disease, MESH: Male, MESH: Prospective Studies, MESH: Immobilization, Surgery, MESH: France, MESH: Venous Thrombosis, Pulmonary Embolism, business, MESH: Female, Leg Injuries
Abstract

PURPOSE: The aim of our study was to determine the incidence of venous thromboembolism (VTE) in patients with nonsurgical isolated lower limb injury and to determine the risk factors associated with the development of the condition. METHODS: This observational study was conducted in French hospital emergency departments (EDs). Patients older than 18 years presenting with nonsurgical isolated lower limb injury below the knee in the ED were included. Deep VTE was diagnosed with compression ultrasound. The final diagnosis of VTE was confirmed by an expert panel. RESULTS: Three thousand six hundred ninety-eight patients were included, and compression ultrasound examination was obtained in 2761 (75%) of them who were retained in the analysis. Deep venous thrombosis occurred in 177 patients and nonfatal pulmonary embolism in 1 patient. The incidence of VTE, mainly distal and asymptomatic, was 6.4% (95% confidence interval, 5.5%-7.4%). In a multivariate analysis, predictive variables of VTE were age of at least 50 years (odds ratio, 3.14; P < .0001), rigid immobilization (odds ratio, 2.70; P < .0001), no weight bearing (odds ratio, 4.11; P = .0015), and severe injury (odds ratio, 1.88; P = .0002). The discriminant analysis showed that age was the only variable independent of an antithrombotic prophylaxis associated with VTE. CONCLUSION: The incidence of VTE was 6.4% in patients with nonsurgical lower limb injury. Rigid immobilization, recommendation not to bear weight, severe injury, and age of at least 50 years should be considered as risk factors for VTE. Emergency physicians should also take age into account when prescribing antithrombotic prophylaxis.

Published
2007
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24. The European guideline on management of major bleeding and coagulopathy following trauma: fifth edition

Author

Donat R. Spahn, Bertil Bouillon, Vladimir Cerny, Jacques Duranteau, Daniela Filipescu, Beverley J. Hunt, Radko Komadina, Marc Maegele, Giuseppe Nardi, Louis Riddez, Charles-Marc Samama, Jean-Louis Vincent, and Rolf Rossaint

Subjects
Coagulopathy, Emergency medicine, Haemostasis, Practice guideline, Trauma, Medical emergencies. Critical care. Intensive care. First aid, RC86-88.9
Abstract

Abstract Background Severe traumatic injury continues to present challenges to healthcare systems around the world, and post-traumatic bleeding remains a leading cause of potentially preventable death among injured patients. Now in its fifth edition, this document aims to provide guidance on the management of major bleeding and coagulopathy following traumatic injury and encourages adaptation of the guiding principles described here to individual institutional circumstances and resources. Methods The pan-European, multidisciplinary Task Force for Advanced Bleeding Care in Trauma was founded in 2004, and the current author group included representatives of six relevant European professional societies. The group applied a structured, evidence-based consensus approach to address scientific queries that served as the basis for each recommendation and supporting rationale. Expert opinion and current clinical practice were also considered, particularly in areas in which randomised clinical trials have not or cannot be performed. Existing recommendations were re-examined and revised based on scientific evidence that has emerged since the previous edition and observed shifts in clinical practice. New recommendations were formulated to reflect current clinical concerns and areas in which new research data have been generated. Results Advances in our understanding of the pathophysiology of post-traumatic coagulopathy have supported improved management strategies, including evidence that early, individualised goal-directed treatment improves the outcome of severely injured patients. The overall organisation of the current guideline has been designed to reflect the clinical decision-making process along the patient pathway in an approximate temporal sequence. Recommendations are grouped behind the rationale for key decision points, which are patient- or problem-oriented rather than related to specific treatment modalities. While these recommendations provide guidance for the diagnosis and treatment of major bleeding and coagulopathy, emerging evidence supports the author group’s belief that the greatest outcome improvement can be achieved through education and the establishment of and adherence to local clinical management algorithms. Conclusions A multidisciplinary approach and adherence to evidence-based guidance are key to improving patient outcomes. If incorporated into local practice, these clinical practice guidelines have the potential to ensure a uniform standard of care across Europe and beyond and better outcomes for the severely bleeding trauma patient.

Published
2019
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