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1. Prehospital Lyophilized Plasma Transfusion for Trauma-Induced Coagulopathy in Patients at Risk for Hemorrhagic Shock

Author

Jost, Daniel, Lemoine, Sabine, Lemoine, Frédéric, Derkenne, Clément, Beaume, Sébastien, Lanoë, Vincent, Maurin, Olga, Louis-Delaurière, Emilie, Delacote, Maëlle, Dang-Minh, Pascal, Franchin-Frattini, Marilyn, Bihannic, René, Savary, Dominique, Levrat, Albrice, Baudouin, Clémence, Trichereau, Julie, Salomé, Marina, Frattini, Benoit, Ha, Vivien Hong Tuan, Jouffroy, Romain, Seguineau, Edouard, Titreville, Rudy, Roquet, Florian, Stibbe, Olivier, Vivien, Benoit, Verret, Catherine, Bignand, Michel, Travers, Stéphane, Martinaud, Christophe, Arock, Michel, Raux, Mathieu, Prunet, Bertrand, Ausset, Sylvain, Sailliol, Anne, Tourtier, Jean-Pierre, Albinni, Souha, Attias, Arié, Benchetritt, Deborah, Benichou, Laura, Boizat, Stéphane, Boutinaud, Philippe, Calinet, Alexandra, Camoin-Jau, Laurence, Cerro, Valérie, Cesareo, Eric, Chahir, Noureddine, Chassery, Carine, Chollet, Charlotte, Choubard, Anouk, Clavere, Gaëlle, Clavier, Benoit, Courtade, Henri, Creppy, Séverine, David, Jean-Stéphane, de Raucourt, Emmanuelle, Debord, Sophie, Delort, Josée, Deruaz-Cunsolo, Christine, Dettori, Isabelle, Dhers, Marion, Dias, Patricia, Diaz, Maxime, Dieuset, Sophie, Dubien, Pierre-Yves, Duchateau, François-Xavier, Duranteau, Jacques, Fiot, Charlotte, Flocard, Bernard, Foissaud, Vincent, Fournier, Marc, Francois, Anne, Gaget, Gilles, Garnier, Benjamin, Gaste, Jean-Louis, Grimault, Olivier, Gueugniaud, Pierre-Yves, Idir, Zakia, Burnichon, Jerome, Journois, Didier, Blanc-Jouvan, Florence, Kerbaul, Francois, Klein, Isabelle, Lafitte, Blandine, Langeron, Olivier, Lassale, Bernard, Lebouc, Marie, Lecarpentier, Eric, Lejeune, Stephanie, Lemaire, Mickaël, Leniger, Catherine, Leone, Marc, Leostic, Claudie, Lutomski, Chantal, Sailliol, Marianne, Martin, Claude-Denis, Matheron, Catherine, Mathieu, Jacques, Mendes, Anne-Christine, Mermillod-Blondin, Romain, Neuschwander, Arthur, Oueidat, Nathalie, Ould-Ahmed, Mehdi, Ozier, Yves, Paugam, Catherine, Peduzzi, Franck, Petermann, Alexandre, Peytel, Eric, Picou-Leblanc, Muriel, Pinero, David, Plaisance, Patrick, Raba, Michel, Ricard, Damien, Romanacce, Isabelle, Rossignol, Thomas, Rougelin-Clapasson, Christine, Saint-Paul, Amelie, Idri, Salim, Scotto, Christine, Senent, Laurence, Smadja, David, Tazarourte, Karim, Topin, Francois, Trichet, Catherine, Vocel, Alexia, Laboratoire de biologie et modélisation de la cellule (LBMC UMR 5239), École normale supérieure de Lyon (ENS de Lyon)-Université Claude Bernard Lyon 1 (UCBL), Université de Lyon-Université de Lyon-Institut National de la Santé et de la Recherche Médicale (INSERM)-Centre National de la Recherche Scientifique (CNRS), Brigade de sapeurs pompiers de Paris (BSPP), CEDRIC. Réseaux et Objets Connectés (CEDRIC - ROC), Centre d'études et de recherche en informatique et communications (CEDRIC), Ecole Nationale Supérieure d'Informatique pour l'Industrie et l'Entreprise (ENSIIE)-Conservatoire National des Arts et Métiers [CNAM] (CNAM), HESAM Université - Communauté d'universités et d'établissements Hautes écoles Sorbonne Arts et métiers université (HESAM)-HESAM Université - Communauté d'universités et d'établissements Hautes écoles Sorbonne Arts et métiers université (HESAM)-Ecole Nationale Supérieure d'Informatique pour l'Industrie et l'Entreprise (ENSIIE)-Conservatoire National des Arts et Métiers [CNAM] (CNAM), HESAM Université - Communauté d'universités et d'établissements Hautes écoles Sorbonne Arts et métiers université (HESAM)-HESAM Université - Communauté d'universités et d'établissements Hautes écoles Sorbonne Arts et métiers université (HESAM), École des Hautes Études en Santé Publique [EHESP] (EHESP), Institut de recherche en santé, environnement et travail (Irset), Université d'Angers (UA)-Université de Rennes (UR)-École des Hautes Études en Santé Publique [EHESP] (EHESP)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Structure Fédérative de Recherche en Biologie et Santé de Rennes ( Biosit : Biologie - Santé - Innovation Technologique ), Centre Hospitalier Universitaire d'Angers (CHU Angers), PRES Université Nantes Angers Le Mans (UNAM), Centre Hospitalier Annecy-Genevois [Saint-Julien-en-Genevois], Hôpital Foch [Suresnes], CIC - Mère Enfant Necker Cochin Paris Centre (CIC 1419), Hôpital Cochin [AP-HP], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Université Paris Cité (UPCité), Hôpital Européen Georges Pompidou [APHP] (HEGP), Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Hôpitaux Universitaires Paris Ouest - Hôpitaux Universitaires Île de France Ouest (HUPO), Service de biostatistique et information médicale de l’hôpital Saint Louis (Equipe ECSTRA) (SBIM), Institut National de la Santé et de la Recherche Médicale (INSERM)-Institut national du cancer [Boulogne] (INCA)-Hopital Saint-Louis [AP-HP] (AP-HP), Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Université Paris Cité (UPCité), GHU AP-HP Centre Université de Paris, CHU Necker - Enfants Malades [AP-HP], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP), Institut de Recherche Biomédicale des Armée [Brétigny/Orge] (IRBA), Centre de Transfusion Sanguine des Armées (CTSA), Service de Santé des Armées, Centre de Recherche des Cordeliers (CRC (UMR_S_1138 / U1138)), École Pratique des Hautes Études (EPHE), Université Paris sciences et lettres (PSL)-Université Paris sciences et lettres (PSL)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Sorbonne Université (SU)-Université Paris Cité (UPCité), Neurophysiologie Respiratoire Expérimentale et Clinique (UMRS 1158), Institut National de la Santé et de la Recherche Médicale (INSERM)-Sorbonne Université (SU), CHU Pitié-Salpêtrière [AP-HP], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU), AP-HP - Hôpital Antoine Béclère [Clamart], CHU Henri Mondor [Créteil], Université de Bretagne Occidentale - UFR Médecine et Sciences de la Santé (UBO UFR MSS), and Université de Brest (UBO)

Subjects
[SDV]Life Sciences [q-bio]
Abstract

International audience; IMPORTANCE 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

Published
2022
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2. Prehospital Lyophilized Plasma Transfusion for Trauma-Induced Coagulopathy in Patients at Risk for Hemorrhagic Shock: A Randomized Clinical Trial.

Author

Jost D, Lemoine S, Lemoine F, Derkenne C, Beaume S, Lanoë V, Maurin O, Louis-Delaurière E, Delacote M, Dang-Minh P, Franchin-Frattini M, Bihannic R, Savary D, Levrat A, Baudouin C, Trichereau J, Salomé M, Frattini B, Ha VHT, Jouffroy R, Seguineau E, Titreville R, Roquet F, Stibbe O, Vivien B, Verret C, Bignand M, Travers S, Martinaud C, Arock M, Raux M, Prunet B, Ausset S, Sailliol A, and Tourtier JP

Subjects
Adult, Blood Component Transfusion, Blood Transfusion, Humans, Male, Plasma, Saline Solution, Emergency Medical Services methods, Shock, Hemorrhagic etiology, Shock, Hemorrhagic therapy
Abstract

Importance: 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.

Published
2022
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