Sophie Rym Hamada1, Romain Pirracchio, Jocelyn Beauchesne, Mohammed Nadjib Benlaldj, Eric Meaudre, Marc Leone, Julien Pottecher, Paer Selim Abback, Tobias Gauss, Mathieu Boutonnet, Fabrice Cook, Delphine Garrigue, Frédéric Lesache, Josse Julie, Alexandra Rouquette, Jacques Duranteau. 1. From the Department of Anesthesiology and Critical Care (S.R.H., J.D.), AP-HP, Bicêtre Hôpitaux Universitaires Paris-Sud, Université Paris-Sud, Le Kremlin Bicêtre; CESP (S.R.H., A.R.), INSERM, Université Paris-Sud, UVSQ, Université Paris-Saclay; CESP (S.R.H., A.R.), INSERM, Maison de Solenn; Department of Anesthesiology and Critical Care (R.M.), AP-HP, Hôpital Europeen Georges Pompidou, Universite Paris Descartes; École Polytechnique (J.B., M.N.B.), Paris; Department of Anesthesiology and Critical Care (E.M.), Military Teaching Hospital Sainte-Anne, Toulon; French Military Health Service Academy (E.M.), Ecole du Val-de-Grâce, Paris; Department of Anesthesiology and Critical Care (M.L.), AP-HM, Aix Marseille Université, Hôpital Nord, Marseille; Department of Anesthesiology and Critical Care (J.P.), Hôpitaux Universitaires de Strasbourg; Faculté de Médecine (J.P.), Fédération de Médecine Translationnelle de Strasbourg, Université de Strasbourg, Strasbourg, France; Department of Anesthesiology and Critical Care (P.S.A., T.G.), Beaujon Hospital, HUPNVS, AP-HP, Clichy; Department of Anesthesiology and Intensive Care (M.B.), Percy Military Teaching Hospital, Clamart; Department of Anesthesiology and Critical Care (F.C.), AP-HP, Hôpital Henri Mondor, Université Paris Est, Créteil; CHU Lille (D.G.), Pôle de l'Urgence, Pôle d'Anesthesie-Réanimation, Lille; Department of Anesthesiology and Critical Care (F.L.), Centre Hospitalier Universitaire Pitié-Salpêtrière, Assistance Publique-Hôpitaux de Paris, University Pierre et Marie Curie; CMAP (J.J.), INRIA, XPOP, École Polytechnique, Paris; Public Health and Epidemiology Department (A.R.), AP-HP, Bicêtre Hôpitaux Universitaires Paris-Sud, Le Kremlin-Bicêtre, France.
Abstract
BACKGROUND: Fibrinogen concentrate is widely used in traumatic hemorrhagic shock despite weak evidence in the literature. The aim of the study was to evaluate the effect of fibrinogen concentrate administration within the first 6 hours on 24-hour all-cause mortality in traumatic hemorrhagic shock using a causal inference approach. METHODS: Observational study from a French multicenter prospective trauma registry was performed. Hemorrhagic shock was defined as transfusion of four or more red blood cell units within the first 6 hours after admission. The confounding variables for the outcome (24-hour all-cause mortality) and treatment allocation (fibrinogen concentrate administration within the first 6 hours) were chosen by a Delphi method. The propensity score was specified with a data-adaptive algorithm and a doubly-robust approach with inverse proportionality of treatment weighting allowed to compute the average treatment effect. Sensitivity analyses were performed. RESULTS: Of 14,336 patients in the registry during the study period, 1,027 in hemorrhagic shock were analyzed (758 receiving fibrinogen concentrate within 6 hours and 269 not receiving fibrinogen concentrate). The average treatment effect, expressed as a risk difference, was -0.031 (95% confidence interval, -0.084 to 0.021). All sensitivity analysis confirmed the results. CONCLUSIONS: Fibrinogen concentrate administration within the first 6 hours of a traumatic hemorrhagic shock did not decrease 24-hour all-cause mortality. LEVEL OF EVIDENCE: Prognostic, level III.
BACKGROUND:Fibrinogen concentrate is widely used in traumatic hemorrhagic shock despite weak evidence in the literature. The aim of the study was to evaluate the effect of fibrinogen concentrate administration within the first 6 hours on 24-hour all-cause mortality in traumatic hemorrhagic shock using a causal inference approach. METHODS: Observational study from a French multicenter prospective trauma registry was performed. Hemorrhagic shock was defined as transfusion of four or more red blood cell units within the first 6 hours after admission. The confounding variables for the outcome (24-hour all-cause mortality) and treatment allocation (fibrinogen concentrate administration within the first 6 hours) were chosen by a Delphi method. The propensity score was specified with a data-adaptive algorithm and a doubly-robust approach with inverse proportionality of treatment weighting allowed to compute the average treatment effect. Sensitivity analyses were performed. RESULTS: Of 14,336 patients in the registry during the study period, 1,027 in hemorrhagic shock were analyzed (758 receiving fibrinogen concentrate within 6 hours and 269 not receiving fibrinogen concentrate). The average treatment effect, expressed as a risk difference, was -0.031 (95% confidence interval, -0.084 to 0.021). All sensitivity analysis confirmed the results. CONCLUSIONS:Fibrinogen concentrate administration within the first 6 hours of a traumatic hemorrhagic shock did not decrease 24-hour all-cause mortality. LEVEL OF EVIDENCE: Prognostic, level III.
Authors: S R Hamada; D Garrigue; H Nougue; A Meyer; M Boutonnet; E Meaudre; A Culver; E Gaertner; G Audibert; B Vigué; J Duranteau; A Godier Journal: Crit Care Date: 2022-02-21 Impact factor: 9.097