Prehospital Lyophilized Plasma Transfusion for Trauma-Induced Coagulopathy in Patients at Risk for Hemorrhagic Shock
2022; American Medical Association; Volume: 5; Issue: 7 Linguagem: Inglês
10.1001/jamanetworkopen.2022.23619
ISSN2574-3805
AutoresDaniel Jost, Sabine Lemoine, F. Lemoine, Clément Derkenne, Sébastien Beaume, Vincent Lanoë, Olga Maurin, Emilie Louis-Delaurière, Maëlle Delacôte, Pascal Dang-Minh, Marilyn Franchin-Frattini, René Bihannic, Dominique Savary, Albrice Levrat, Clémence Baudouin, Julie Trichereau, Marina Salomé, Benoît Frattini, Vivien Hong Tuan Ha, Romain Jouffroy, Edouard Seguineau, Rudy Titreville, Florian Roquet, Olivier Stibbe, Benoît Vivien, C. Verret, Michel Bignand, Stéphane Travers, Christophe Martinaud, Michel Arock, Mathieu Raux, Bertrand Prunet, Sylvain Ausset, A. Sailliol, Jean-Pierre Tourtier, Souha Albinni, Arié Attias, Deborah Benchetritt, L Benichou, René Bihannic, Stéphane Boizat, Philippe Boutinaud, Alexandra Calinet, Laurence Camoin‐Jau, Valérie Cerro, E. Cesaréo, Noureddine Chahir, Carine Chassery, C. Chollet, Anouk Choubard, Gaëlle Clavere, B. Clavier, Henri Courtade, Séverine Creppy, Jean David, Emmanuelle de Raucourt, Sophie Debord, J Delort, Christine Deruaz-Cunsolo, Isabelle Dettori, M. Dhers, Patrícia Dias, Maxime Diaz, Sophie Dieuset, Pierre-Yves Dubien, François-Xavier Duchâteau, Jacques Duranteau, Charlotte Fiot, Bernard Flocard, Vincent Foissaud, Marc Fournier, Anne Isabelle François, Gilles Gaget, B Garnier, Jean-Louis Gaste, O. Grimault, Pierre‐Yves Gueugniaud, Zakia Idir, Jerome Burnichon, Didier Journois, Florence Blanc‐Jouvan, François Kerbaul, Isabelle Klein, B. Lafitte, Olivier Langeron, B. Lassale, Marie Lebouc, Éric Lecarpentier, Stéphanie Lejeune, M. Claude Lemaire, C. Leniger, Marc Léone, C. Léostic, Chantal Lutomski, Marianne Sailliol, Claude-Denis Martin, Catherine Matheron, Jacques R.R. Mathieu, Anne‐Christine Mendes, Romain Mermillod-Blondin, Arthur Neuschwander, Nathalie Oueidat, M. Ould-Ahmed, Yves Ozier, Cathérine Paugam‐Burtz, Franck Peduzzi, A. Petermann, E. Peytel, Muriel Picou-Leblanc, David P. Piñero, Patrick Plaisance, Michel Raba, Damien Ricard, Isabelle Romanacce, Thomas Rossignol, Christine Rougelin-Clapasson, Amelie Saint-Paul, Salim Idri, Christine Scotto, Laurence Senent, David M. Smadja, Karim Tazarourte, François Topin, Catherine Trichet, Alexia Vocel,
Tópico(s)Cardiac Arrest and Resuscitation
ResumoImportance Blood transfusion is a mainstay of therapy for trauma-induced coagulopathy, but the optimal modalities for plasma transfusion in the prehospital setting remain to be defined. Objective To determine whether lyophilized plasma transfusion can reduce the incidence of trauma-induced coagulopathy compared with standard care consisting of normal saline infusion. Design, Setting, and Participants This randomized clinical trial was performed at multiple centers in France involving prehospital medical teams. Participants included 150 adults with trauma who were at risk for hemorrhagic shock and associated coagulopathy between April 1, 2016, and September 30, 2019, with a 28-day follow-up. Data were analyzed from November 1, 2019, to July 1, 2020. Intervention Patients were randomized in a 1:1 ratio to receive either plasma or standard care with normal saline infusion (control). Main Outcomes and Measures The primary outcome was the international normalized ratio (INR) on arrival at the hospital. Secondary outcomes included the need for massive transfusion and 30-day survival. As a safety outcome, prespecified adverse events included thrombosis, transfusion-related acute lung injury, and transfusion-associated circulatory overload. Results Among 150 randomized patients, 134 were included in the analysis (median age, 34 [IQR, 26-49] years; 110 men [82.1%]), with 68 in the plasma group and 66 in the control group. Median INR values were 1.21 (IQR, 1.12-1.49) in the plasma group and 1.20 (IQR, 1.10-1.39) in the control group (median difference, −0.01 [IQR, −0.09 to 0.08]; P = .88). The groups did not differ significantly in the need for massive transfusion (7 [10.3%] vs 4 [6.1%]; relative risk, 1.78 [95% CI, 0.42-8.68]; P = .37) or 30-day survival (hazard ratio for death, 1.07 [95% CI, 0.44-2.61]; P = .89). In the full intention-to-treat population (n = 150), the groups did not differ in the rates of any of the prespecified adverse events. Conclusions and Relevance In this randomized clinical trial including severely injured patients at risk for hemorrhagic shock and associated coagulopathy, prehospital transfusion of lyophilized plasma was not associated with significant differences in INR values vs standard care with normal saline infusion. Nevertheless, these findings show that lyophilized plasma transfusion is a feasible and safe procedure for this patient population. Trial Registration ClinicalTrials.gov Identifier:NCT02736812
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