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5 results on '"A.-S. Ducloy-Bouthors"'

1. Traces pilot pharmacokinetic study dataset

Author

Gilles Lebuffe, F Loingeville, Sixtine Gilliot, Pascal Odou, B Hennart, A S Ducloy-Bouthors, M Jeanne, CHU Lille, Institut Pasteur de Lille, Université de Lille, Groupe de Recherche sur les formes Injectables et les Technologies Associées - ULR 7365 [GRITA], IMPact de l'Environnement Chimique sur la Santé humaine (IMPECS) - ULR 4483, METRICS : Evaluation des technologies de santé et des pratiques médicales - ULR 2694, Groupe de Recherche sur les formes Injectables et les Technologies Associées (GRITA) - ULR 7365, Groupe de Recherche sur les formes Injectables et les Technologies Associées - ULR 7365 (GRITA), Université de Lille-Centre Hospitalier Régional Universitaire [Lille] (CHRU Lille), Hôpital Jeanne de Flandre [Lille], Evaluation des technologies de santé et des pratiques médicales - ULR 2694 (METRICS), and Centre Hospitalier Régional Universitaire [Lille] (CHRU Lille)-Université de Lille

Subjects
Tranexamic acid, [SDV]Life Sciences [q-bio], Body weight, lcsh:Computer applications to medicine. Medical informatics, Postpartum haemorrhage, 03 medical and health sciences, 0302 clinical medicine, Blood loss, Pharmacokinetics, Medicine, Caesarean section, lcsh:Science (General), Data Article, 030304 developmental biology, Volume of distribution, 0303 health sciences, Multidisciplinary, business.industry, Patient data, lcsh:R858-859.7, business, Nuclear medicine, Intravenous, 030217 neurology & neurosurgery, medicine.drug, lcsh:Q1-390
Abstract

The dataset displays the pharmacokinetics data obtained from the TRACES pilot study. The nine patients included were undergoing haemorrhagic caesarean section (blood loss > 800 mL) and receiving a single i.v dose of tranexamic acid (0.5, 1 or 2 g over 1 min). The dataset gathers the tranexamic acid blood and urinary concentrations. With these first elements, a pharmacokinetic compartment model was built as described in Gilliot et al. and the individual pharmacokinetic parameters were estimated. In parallel, the patients anthropometric, biological, and clinical characteristics were collected. The correlation between the patient data and the estimated individual pharmacokinetic parameters were tested. The correlation tests revealed that the dose, the height, the body weight, and the ideal bodyweight had and impact on the volume of distribution of tranexamic acid. According to these results, these latter covariates were explored using a multi-regression analysis in Gilliot et al.

Published
2020
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2. Hypothesis for a partially non urinary elimination of tranexamic acid in haemorrhagic caesarean section: Traces pilot pharmacokinetic study: Pharmacokinetics of tranexamic acid in obstetrics

Author

F Loingeville, Sixtine Gilliot, B Hennart, Gilles Lebuffe, A S Ducloy-Bouthors, Pascal Odou, and M Jeanne

Subjects
medicine.medical_specialty, medicine.medical_treatment, Urinary system, Population, Urology, Pharmaceutical Science, 02 engineering and technology, 030226 pharmacology & pharmacy, 03 medical and health sciences, 0302 clinical medicine, Pharmacokinetics, Pregnancy, medicine, Humans, Caesarean section, Compartment (pharmacokinetics), education, Volume of distribution, education.field_of_study, business.industry, Cesarean Section, 021001 nanoscience & nanotechnology, Urinary elimination, Obstetrics, Tranexamic Acid, Injections, Intravenous, Female, 0210 nano-technology, business, Tranexamic acid, medicine.drug
Abstract

Background : In previous studies, the choice of doses of tranexamic acid was empirically defined as no pharmacokinetic study had been conducted in haemorrhagic caesarean section. Objective : The objective was to build a pharmacokinetic model in patients receiving a single 0.5, 1 or 2 g intravenous bolus. Method : A preliminary monocentric open study was performed in the Lille centre. Blood samples and one urinary sample were collected in the 6 hours following the injection. Nine patients were included. Tranexamic acid concentration was measured using liquid chromatography system coupled with tandem mass spectrometry. We used Monolix 2019R1 for population pharmacokinetic modelling. A structural model was constructed followed by the investigation of potential covariates. Results : Data were best described with a two-compartment model with a double first-order elimination from the central compartment. The model was improved when the variable ideal weight per dose was affected as a covariate for the apparent volume of distribution. Assuming a dose of 1 g and a height of 160 cm, the pharmacokinetic parameters were estimated at 10.26 L.h−1 for total clearance, 11.5 L for the volume of the central compartment, 15.8 L for the volume of the second compartment, a diffusional clearance of 30.36 L.h−1 , and a urinary excretion fraction of 25.8%. Conclusions : The population pharmacokinetic model of tranexamic acid in haemorrhagic caesarean section was successfully established in our tiny sample of patients. The results of this preliminary TRACES pharmacokinetic study suggested that elimination of tranexamic acid is partially non urinary in contrast with healthy patients.

Published
2019

3. Core outcome sets for prevention and treatment of postpartum haemorrhage: an international Delphi consensus study

Author

Ahmet Metin Gülmezoglu, G. Gyte, K. Gutteridge, Peter William Collins, A. S. Ducloy-Bouthors, Jennifer Blum, Shuba Mallaiah, Anna Cuthbert, Nasreen Aflaifel, Shireen Meher, Paula R Williamson, Declan Devane, Zulfiqar A Bhutta, Andrew Weeks, J. M. Smith, Jamie J Kirkham, Caroline S.E. Homer, Zarko Alfirevic, A. Bishop, Edgardo Abalos, and Bukola Fawole

Subjects
medicine.medical_specialty, Blood transfusion, Consensus, Delphi Technique, medicine.medical_treatment, International Cooperation, Population, Breastfeeding, Delphi method, Outcome Assessment (Health Care), 03 medical and health sciences, 0302 clinical medicine, Patient satisfaction, Pregnancy, Outcome Assessment, Health Care, Medicine, Humans, Obstetrics & Reproductive Medicine, Adverse effect, education, education.field_of_study, 030219 obstetrics & reproductive medicine, business.industry, Postpartum Hemorrhage, Obstetrics and Gynecology, medicine.disease, Systematic review, Patient Satisfaction, Family medicine, Maternal death, Female, business
Abstract

© 2018 Royal College of Obstetricians and Gynaecologists Objective: To develop core outcome sets (COS) for studies evaluating interventions for (1) prevention and (2) treatment of postpartum haemorrhage (PPH), and recommendations on how to report the COS. Design: A two-round Delphi survey and face-to-face meeting. Population: Healthcare professionals and women's representatives. Methods: Outcomes were identified from systematic reviews of PPH studies and stakeholder consultation. Participants scored each outcome in the Delphi on a Likert scale between 1 (not important) and 9 (critically important). Results were discussed at the face-to-face meeting to agree the final COS. Consensus at the meeting was defined as ≥ 70% of participants scoring the outcome as critically important (7–9). Lectures, discussion and voting were used to agree how to report COS outcomes. Main outcome measures: Outcomes from systematic reviews and consultations. Results: Both Delphi rounds were completed by 152/205 (74%) participants for prevention and 143/197 (73%) for treatment. For prevention of PPH, nine core outcomes were selected: blood loss, shock, maternal death, use of additional uterotonics, blood transfusion, transfer for higher level of care, women's sense of wellbeing, acceptability and satisfaction with the intervention, breastfeeding, and adverse effects. For treatment of PPH, 12 core outcomes were selected: blood loss, shock, coagulopathy, hysterectomy, organ dysfunction, maternal death, blood transfusion, use of additional haemostatic intervention, transfer for higher level of care, women's sense of wellbeing, acceptability and satisfaction with the intervention, breastfeeding, and adverse effects. Recommendations were developed on how to report these outcomes where possible. Conclusions: These COS will help standardise outcome reporting in PPH trials. Tweetable abstract: Core outcome sets for PPH: nine core outcomes for PPH prevention and 12 core outcomes for PPH treatment.

Published
2018

4. 37th International Symposium on Intensive Care and Emergency Medicine (part 2 of 3)

Author

D. Rob, R. Špunda, J. Lindner, J. Šmalcová, O. Šmíd, T. Kovárník, A. Linhart, J. Bìlohlávek, M. M. Marinoni, G. Cianchi, S. Trapani, M. L. Migliaccio, L. Gucci, M. Bonizzoli, A. Cramaro, M. Cozzolino, S. Valente, A. Peris, E. Grins, E. Kort, M. Weiland, N. Manandhar Shresta, P. Davidson, L. Algotsson, S. Fitch, G. Marco, J. Sturgill, S. Lee, M. Dickinson, T. Boeve, A. Khaghani, P. Wilton, S. Jovinge, A. N. Ahmad, R. Loveridge, S. Vlachos, S. Patel, E. Gelandt, L. Morgan, S. Butt, M. Whitehorne, V. Kakar, C. Park, M. Hayes, C. Willars, T. Hurst, T. Best, A. Vercueil, G. Auzinger, B. Adibelli, N. Akovali, A. Torgay, P. Zeyneloglu, A. Pirat, Z. Kayhan, S. S. Schmidbauer, J. Herlitz, T. Karlsson, H. Friberg, R. Knafelj, P. Radsel, F. Duprez, T. Bonus, G. Cuvelier, S. Mashayekhi, M. Maka, S. Ollieuz, G. Reychler, R. Mosaddegh, S. Abbasi, S. Talaee, V. Z. Zotzmann, D. S. Staudacher, T. W. Wengenmayer, D. D. Dürschmied, C. B. Bode, A. Nelskylä, J. Nurmi, M. Jousi, A. Schramko, E. Mervaala, G. Ristagno, M. Skrifvars, G. Ozsoy, T. Kendirli, E. Azapagasi, O. Perk, U. Gadirova, E. Ozcinar, M. Cakici, C. Baran, S. Durdu, A. Uysalel, M. Dogan, M. Ramoglu, T. Ucar, E. Tutar, S. Atalay, R. Akar, M. Kamps, G. Leeuwerink, J. Hofmeijer, O. Hoiting, J. Van der Hoeven, C. Hoedemaekers, A. Konkayev, V. Kuklin, T. Kondratyev, M. Konkayeva, N. Akhatov, M. Sovershaev, T. Tveita, V. Dahl, L. Wihersaari, M. B. Skrifvars, S. Bendel, K. M. Kaukonen, J. Vaahersalo, J. Romppanen, V. Pettilä, M. Reinikainen, A. Lybeck, T. Cronberg, N. Nielsen, M. Rauber, K. Steblovnik, A. Jazbec, M. Noc, P. Kalasbail, F. Garrett, E. Kulstad, D. J. Bergström, H. R. Olsson, S. Schmidbauer, I. Mandel, S. Mikheev, Y. Podoxenov, I. Suhodolo, A. Podoxenov, J. Svirko, A. Sementsov, L. Maslov, V. Shipulin, L. V. Vammen, S. R. Rahbek, N. S. Secher, J. P. Povlsen, N. J. Jessen, B. L. Løfgren, A. G. Granfeldt, A. Grossestreuer, S. Perman, P. Patel, S. Ganley, J. Portmann, M. Cocchi, M. Donnino, Y. Nassar, S. Fathy, A. Gaber, S. Mokhtar, Y. C. Chia, R. Lewis-Cuthbertson, K. Mustafa, A. Sabra, A. Evans, P. Bennett, W. Eertmans, C. Genbrugge, W. Boer, J. Dens, C. De Deyne, F. Jans, A. Skorko, M. Thomas, M. Casadio, A. Coppo, A. Vargiolu, J. Villa, M. Rota, L. Avalli, G. Citerio, J. B. Moon, J. H. Cho, C. W. Park, T. G. Ohk, M. C. Shin, M. H. Won, P. Papamichalis, V. Zisopoulou, E. Dardiotis, S. Karagiannis, D. Papadopoulos, T. Zafeiridis, D. Babalis, A. Skoura, I. Staikos, A. Komnos, S. Silva Passos, F. Maeda, L. Silva Souza, A. Amato Filho, T. Araújo Guerra Granjeia, M. Schweller, D. Franci, M. De Carvalho Filho, T. Martins Santos, P. De Azevedo, R. Wall, I. Welters, P. Tansuwannarat, P. Sanguanwit, T. Langer, M. Carbonara, A. Caccioppola, C. Ferraris Fusarini, E. Carlesso, E. Paradiso, M. Battistini, E. Cattaneo, F. Zadek, R. Maiavacca, N. Stocchetti, A. Pesenti, A. Ramos, F. Acharta, J. Toledo, M. Perezlindo, L. Lovesio, A. Dogliotti, C. Lovesio, N. Schroten, B. Van der Veen, M. C. De Vries, J. Veenstra, Y. B. Abulhasan, S. Rachel, M. Châtillon-Angle, N. Alabdulraheem, I. Schiller, N. Dendukuri, M. Angle, C. Frenette, S. Lahiri, K. Schlick, S. A. Mayer, P. Lyden, M. Akatsuka, J. Arakawa, M. Yamakage, J. Rubio, J. A. Rubio Mateo-Sidron, R. Sierra, M. Celaya, L. Benitez, S. Alvarez-Ossorio, A. Fernandez, O. Gonzalez, H. Engquist, E. Rostami, P. Enblad, L. Canullo, J. Nallino, M. Perreault, J. Talic, A. J. Frenette, L. Burry, F. Bernard, D. R. Williamson, D. Adukauskiene, J. Cyziute, A. Adukauskaite, L. Malciene, L. Luca, A. Rogobete, O. Bedreag, M. Papurica, M. Sarandan, C. Cradigati, S. Popovici, C. Vernic, D. Sandesc, V. Avakov, I. Shakhova, H. Trimmel, M. Majdan, G. H. Herzer, C. S. Sokoloff, M. Albert, D. Williamson, C. Odier, J. Giguère, E. Charbonney, Z. Husti, T. Kaptás, Z. Fülep, Z. Gaál, M. Tusa, J. Donnelly, M. Aries, M. Czosnyka, C. Robba, M. Liu, A. Ercole, D. Menon, P. Hutchinson, P. Smielewski, R. López, J. Graf, J. M. Montes, M. Kenawi, A. Kandil, K. Husein, A. Samir, J. Heijneman, J. Huijben, F. Abid-Ali, M. Stolk, J. Van Bommel, H. Lingsma, M. Van der Jagt, R. C. Cihlar, G. Mancino, P. Bertini, F. Forfori, F. Guarracino, D. Pavelescu, I. Grintescu, L. Mirea, S. Alamri, M. Tharwat, N. Kono, H. Okamoto, H. Uchino, T. Ikegami, T. Fukuoka, M. Simoes, E. Trigo, P. Coutinho, J. Pimentel, A. Franci, D. Basagni, M. Boddi, V. Anichini, A. Cecchi, D. Markopoulou, K. Venetsanou, I. Papanikolaou, T. Barkouri, D. Chroni, I. Alamanos, E. Cingolani, M. G. Bocci, L. Pisapia, A. Tersali, S. L. Cutuli, V. Fiore, A. Palma, G. Nardi, M. Antonelli, R. Coke, A. Kwong, D. J. Dwivedi, M. Xu, E. McDonald, J. C. Marshall, A. E. Fox-Robichaud, P. C. Liaw, I. Kuchynska, I. R. Malysh, L. V. Zgrzheblovska, L. Mestdagh, E. F. Verhoeven, I. Hubloue, J. Ruel-laliberte, R. Zarychanski, F. Lauzier, P. Lessard Bonaventure, R. Green, D. Griesdale, R. Fowler, A. Kramer, D. Zygun, T. Walsh, S. Stanworth, C. Léger, A. F. Turgeon, D. M. Baron, J. Baron-Stefaniak, G. C. Leitner, R. Ullrich, O. Tarabrin, A. Mazurenko, Y. Potapchuk, D. Sazhyn, P. Tarabrin, A. González Pérez, J. Silva, V. Artemenko, A. Bugaev, I. Tokar, S. Konashevskaya, I. M. Kolesnikova, E. V. Roitman, T. Rengeiné Kiss, Z. Máthé, L. Piros, E. Dinya, E. Tihanyi, A. Smudla, J. Fazakas, R. Ubbink, P. Boekhorst te, E. Mik, L. Caneva, G. Ticozzelli, S. Pirrelli, D. Passador, F. Riccardi, F. Ferrari, E. M. Roldi, M. Di Matteo, I. Bianchi, G. A. Iotti, G. Zurauskaite, A. Voegeli, M. Meier, D. Koch, S. Haubitz, A. Kutz, M. Bargetzi, B. Mueller, P. Schuetz, G. Von Meijenfeldt, M. Van der Laan, C. Zeebregts, K. B. Christopher, P. Vernikos, T. Melissopoulou, G. Kanellopoulou, M. Panoutsopoulou, D. Xanthis, K. Kolovou, T. Kypraiou, J. Floros, H. Broady, C. Pritchett, M. Marshman, N. Jannaway, C. Ralph, C. L. Lehane, C. K. Keyl, E. Z. Zimmer, D. T. Trenk, A. S. Ducloy-Bouthors, M. J. Jonard, F. Fourrier, F. Piza, T. Correa, A. Marra, J. Guerra, R. Rodrigues, A. Vilarinho, V. Aranda, S. Shiramizo, M. R. Lima, E. Kallas, A. B. Cavalcanti, M. Donoso, P. Vargas, J. McCartney, S. Ramsay, K. McDowall, I. Novitzky-Basso, C. Wright, M Grgic Medic, L Bielen, V Radonic, O Zlopasa, N Gubarev Vrdoljak, V Gasparovic, R Radonic, G. Narváez, D. Cabestrero, L. Rey, M. Aroca, S. Gallego, J. Higuera, R. De Pablo, L. Rey González, G. Narváez Chávez, J. Higuera Lucas, D. Cabestrero Alonso, M. Aroca Ruiz, L. Jaramillo Valarezo, R. De Pablo Sánchez, A. Quinza Real, T. W. Wigmore, I. Bendavid, J. Cohen, I. Avisar, I. Serov, I. Kagan, P. Singer, J Hanison, U Mirza, D Conway, A. Takasu, H. Tanaka, N. Otani, S. Ohde, S. Ishimatsu, F Coffey, P Dissmann, K Mirza, M Lomax, P. Dissmann, F. Coffey, K. Mirza, M. Lomax, JR Miner, R Leto, AM Markota, PG Gradišek, VA Aleksejev, AS Sinkovič, S. Romagnoli, C. Chelazzi, G. Zagli, F. Benvenuti, P. Mancinelli, P. Boninsegni, L. Paparella, A. T. Bos, O. Thomas, T. Goslar, A. Martone, P. R. Sandu, V. A. Rosu, A. Capilnean, P. Murgoi, A. Lecavalier, D. Jayaraman, P. Rico, P. Bellemare, C. Gelinas, T. Nishida, T. Kinoshita, N. Iwata, K. Yamakawa, S. Fujimi, L. Maggi, F. Sposato, G. Citterio, C. Bonarrigo, M. Rocco, V. Zani, R. A. De Blasi, D Alcorn, L Barry, M. A. Riedijk, D. M. Milstein, J. Caldas, R. Panerai, L. Camara, G. Ferreira, E. Bor-Seng-Shu, M. Lima, F. Galas, N. Mian, R. Nogueira, G. Queiroz de Oliveira, J. Almeida, J. Jardim, T. G. Robinson, F. Gaioto, L. A. Hajjar, I. Zabolotskikh, T. Musaeva, W. Saasouh, J. Freeman, A. Turan, S. Saseedharan, E. Pathrose, S. Poojary, J. Messika, Y. Martin, N. Maquigneau, M. Henry-Lagarrigue, C. Puechberty, A. Stoclin, L. Martin-Lefevre, F. Blot, D. Dreyfuss, A. Dechanet, D. Hajage, J. Ricard, E. Almeida, G. Landoni, J. Fukushima, E. Fominskiy, C. De Brito, L. Cavichio, L. Almeida, U. Ribeiro, E. Osawa, R. Boltes, L. Battistella, L. Hajjar, P. Fontela, T. Lisboa, L. Forgiarini Junior, G. F. Friedman, F. Abruzzi, J. Azevedo Peixoto Primo, P. Marques Filho, J. Stormorvski de Andrade, K. Matos Brenner, M. Scorsato boeira, C. Leães, C. Rodrigues, A. Vessozi, A. SantAnna Machado, M. Weiler, H. Bryce, A. Hudson, T. Law, R. Reece-Anthony, A. Molokhia, F. Abtahinezhadmoghaddam, E. Cumber, L. Channon, A. Wong, R. Groome, D. Gearon, J. Varley, A. Wilson, J. Reading, F. G. Zampieri, F. A. Bozza, M. Ferez, H. Fernandes, A. Japiassú, J. Verdeal, A. C. Carvalho, M. Knibel, J. I. Salluh, M. Soares, J. Gao, E. Ahmadnia, B. Patel, A. MacKay, S. Binning, R. J. Pugh, C. Battle, C. Hancock, W. Harrison, T. Szakmany, F. Mulders, J. Vandenbrande, J. Dubois, B. Stessel, K. Siborgs, D. Ramaekers, U. V. Silva, W. S. Homena, G. C. Fernandes, A. P. Moraes, L. Brauer, M. F. Lima, F. De Marco, N. Maric, M. Mackovic, N. Udiljak, CE Bosso, RD Caetano, AP Cardoso, OA Souza, R Pena, MM Mescolotte, IA Souza, GM Mescolotte, H. Bangalore, E. Borrows, D. Barnes, V. Ferreira, L. Azevedo, G. Alencar, A. Andrade, A. Bierrenbach, L. Tadini Buoninsegni, L. Cecci, J. Lindskog, K. Rowland, P. Sturgess, A. Ankuli, R Rosa, T Tonietto, A Ascoli, L Madeira, W Rutzen, M Falavigna, C Robinson, J Salluh, A Cavalcanti, L Azevedo, R Cremonese, D Da Silva, A Dornelles, Y Skrobik, J Teles, T Ribeiro, C Eugênio, C Teixeira, M. Zarei, H. Hashemizadeh, M. Eriksson, G. Strandberg, M. Lipcsey, A. Larsson, M. Lignos, E. Crissanthopoulou, K. Flevari, P. Dimopoulos, A. Armaganidis, JG Golub, AS Stožer, H. Rüddel, C. Ehrlich, C. M. Burghold, C. Hohenstein, J. Winning, W. Sellami, Z. Hajjej, M. Bousselmi, H. Gharsallah, I. Labbene, M. Ferjani, J. Sattler, D. Steinbrunner, H. Poppert, G. Schneider, M. Blobner, K. G. Kanz, S. J. Schaller, K. Apap, G. Xuereb, L. Massa, N. Delvau, A Penaloza, G Liistro, F Thys, I. K. Delattre, P. Hantson, P. M. Roy, P. Gianello, L Hadîrcă, A Ghidirimschi, N Catanoi, N Scurtov, M Bagrinovschi, Y. S. Sohn, Y. C. Cho, B. Golovin, O. Creciun, A. Ghidirimschi, M. Bagrinovschi, R. Tabbara, J. Z. Whitgift, A. Ishimaru, A. Yaguchi, N. Akiduki, M. Namiki, M. Takeda, J. N. Tamminen, A. Uusaro, C. G. Taylor, E. D. Mills, A. D. Mackay, C. Ponzoni, R. Rabello, A. Serpa, M. Assunção, A. Pardini, G. Shettino, T. Corrêa, P. V. Vidal-Cortés, L. Álvarez-Rocha, P. Fernández-Ugidos, A. Virgós-Pedreira, M. A. Pérez-Veloso, I. M. Suárez-Paul, L. Del Río-Carbajo, S. Pita Fernández, A. Castro-Iglesias, A. Butt, A. A. Alghabban, S. K. Khurshid, Z. A. Ali, I. N. Nizami, N. S. Salahuddin, M. Alshahrani, A. W. Alsubaie, A. S. Alshamsy, B. A. Alkhiliwi, H. K. Alshammari, M. B. Alshammari, N. K. Telmesani, R. B. Alshammari, L. P. Asonto, L. P. Damiani, F Bozza, A. El Khattate, M. Bizrane, N. Madani, J. Belayachi, R. Abouqal, D. Ramnarain, B. Gouw-Donders, C. Benstoem, A. Moza, P. Meybohm, C. Stoppe, R. Autschbach, D. Devane, A. Goetzenich, L. U. Taniguchi, L. Araujo, G. Salgado, J. M. Vieira, J. Viana, N. Ziviani, I. Pessach, A. Lipsky, A. Nimrod, M. O´Connor, I. Matot, E. Segal, A. Kluzik, A. Gradys, P. Smuszkiewicz, I. Trojanowska, M. Cybulski, A. De Jong, M. Sebbane, G. Chanques, S. Jaber, R. Rosa, C. Robinson, M. Bessel, L. Cavalheiro, L. Madeira, W. Rutzen, R. Oliveira, J. Maccari, M. Falavigna, E. Sanchez, F. Dutra, C. Dietrich, P. Balzano, J. Rezende, C. Teixeira, S. Sinha, K. Majhi, J. G. Gorlicki, F. P. Pousset, J. Kelly, J. Aron, A. Crerar Gilbert, N. Prevec Urankar, M. Irazabal, M. Bosque, J. Manciño, A. Kotsopoulos, N. Jansen, W. Abdo, Ú. M. Casey, B. O’Brien, R. Plant, and B. Doyle

Subjects
Fatal outcome, business.industry, Traumatic brain injury, 030208 emergency & critical care medicine, 030204 cardiovascular system & hematology, Critical Care and Intensive Care Medicine, medicine.disease, Outcome (game theory), 03 medical and health sciences, 0302 clinical medicine, Anesthesia, Medicine, business, Acute subdural hematoma
Published
2017
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5. Recombinant human FVIIa for reducing the need for invasive second-line therapies in severe refractory postpartum hemorrhage: a multicenter, randomized, open controlled trial

Author

A. Mignon, Géraldine Lavigne-Lissalde, E. Morau, Céline Chauleur, S. Bouvet, A. Bongain, S. Roger-Christoph, P. De Moerloose, A.G. Aya, F.J. Mercier, Jean-Christophe Gris, Pascale Fabbro-Peray, A.-S. Ducloy-Bouthors, M. Raucoules, Françoise Boehlen, Centre Hospitalier Universitaire de Nîmes (CHU Nîmes), Caractéristiques féminines des dysfonctions des interfaces cardio-vasculaires (EA 2992), Université Montpellier 1 (UM1)-Université de Montpellier (UM), Service d'anesthésie [Béclère], Université Paris-Sud - Paris 11 (UP11)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-AP-HP - Hôpital Antoine Béclère [Clamart], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP), Hôpital privé d’Antony, CHU Saint-Etienne, Groupe de recherche sur la thrombose (GRT (EA 3065)), Université Jean Monnet [Saint-Étienne] (UJM), Centre Hospitalier Régional Universitaire [Montpellier] (CHRU Montpellier), Centre Hospitalier Régional Universitaire [Lille] (CHRU Lille), Unité de Soins Intensifs [CHU Cochin], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Hôpital Cochin [AP-HP], Centre Hospitalier Universitaire de Nice (CHU Nice), Hôpital Universitaire de Genève, BESPIM, and Aide à la Décision pour une Médecine Personnalisé - Laboratoire de Biostatistique, Epidémiologie et Recherche Clinique - EA 2415 (AIDMP)

Subjects
Compassionate Use Trials, Time Factors, FVIIa activated, Deep vein, Factor XIIa, Severity of Illness Index, law.invention, Second line, treatment efficacy, Randomized controlled trial, law, Pregnancy, Risk Factors, Venous Thrombosis/chemically induced, Treatment Failure, hysterectomy, Infusions, Intravenous, ComputingMilieux_MISCELLANEOUS, Venous Thrombosis, ddc:616, [SDV.MHEP.HEM]Life Sciences [q-bio]/Human health and pathology/Hematology, Hematology, Delivery mode, Thrombosis, Postpartum Hemorrhage/diagnosis/drug therapy/mortality, 3. Good health, Pulmonary embolism, medicine.anatomical_structure, postpartum hemorrhage, Female, France, Switzerland, Adult, medicine.medical_specialty, macromolecular substances, Hysterectomy, Coagulants/administration & dosage/adverse effects/therapeutic use, Dinoprostone, Drug Administration Schedule, Factor VIII/administration & dosage/adverse effects/therapeutic use, Refractory, medicine, Humans, Hemostatic Techniques/adverse effects, Coagulants, Hemostatic Techniques, business.industry, medicine.disease, Surgery, Dinoprostone/analogs & derivatives/therapeutic use, Relative risk, treatment outcome, business
Abstract

SummaryBackground Case reports on recombinant human factor VIIa (rhuFVIIa) use in women with severe postpartum hemorrhage (PPH) showed encouraging results, but no randomized controlled trial (RCT) is available. Patients and methods Eighty-four women with severe PPH unresponsive to uterotonics were randomized to receive one early single rhuFVIIa infusion (n = 42) or standard care (no rhuFVIIa; n = 42). The primary efficacy outcome measure was the reduction of the need for specific second-line therapies, such as interventional hemostatic procedures, for blood loss and transfusions. The primary safety outcome measure was the number of deaths and thrombotic events during the 5 days following rhuFVIIa infusion. Results rhuFVIIa was associated with a reduction in the number of patients who needed second-line therapies compared with controls (standard care). Specifically, 39/42 (93%) patients in the standard care arm received second-line therapies and 22/42 (52%) patients in the rhuFVIIa arm (absolute difference, 41%; range, 18–63%; relative risk RR, 0.56 [0.42–0.76]). The delivery mode (vaginal or Cesarean section) did not affect the primary outcome. No death occurred. Two venous thrombotic events were recorded in the rhuFVIIa arm: one ovarian vein thrombosis and one deep vein thrombosis with a non-severe pulmonary embolism. Conclusion This open RCT in women with severe PPH refractory to uterotonics shows that rhuFVIIa reduces the need for specific second-line therapies in about one in three patients, with the occurrence of non-fatal venous thrombotic events in one in 20 patients.

Published
2015
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