Efficacy and Safety of Early Administration of 4-Factor Prothrombin Complex Concentrate in Patients With Trauma at Risk of Massive Transfusion - Aix-Marseille Université Accéder directement au contenu
Article Dans Une Revue JAMA Cardiology Année : 2023

Efficacy and Safety of Early Administration of 4-Factor Prothrombin Complex Concentrate in Patients With Trauma at Risk of Massive Transfusion

Jean-François Payen
  • Fonction : Auteur
Jules Greze
  • Fonction : Auteur
Pierluigi Banco
  • Fonction : Auteur
Karine Berger
  • Fonction : Auteur
Stéphanie Druge
  • Fonction : Auteur
Martin Dupuis
  • Fonction : Auteur
Laure Janin
  • Fonction : Auteur
Caroline Machuron
  • Fonction : Auteur
Marine Thomas
  • Fonction : Auteur
Clotilde Schilte
  • Fonction : Auteur
Emmanuelle Hamad
  • Fonction : Auteur
Laurent Zieleskiewicz
  • Fonction : Auteur
Gary Duclos
  • Fonction : Auteur
Charlotte Arbelot
  • Fonction : Auteur
Karine Bezulier
  • Fonction : Auteur
Caroline Jeantrelle
  • Fonction : Auteur
Mathieu Raux
  • Fonction : Auteur
Pauline Glasman
  • Fonction : Auteur
Anatole Harrois
  • Fonction : Auteur
Virginie Tarazona
  • Fonction : Auteur
Aline Lambert
  • Fonction : Auteur
Olivia Vassal
  • Fonction : Auteur
Anne Li
  • Fonction : Auteur
Nicolas Grillot
  • Fonction : Auteur
Loïs Henry
  • Fonction : Auteur
Elise Blonde
  • Fonction : Auteur
Benjamin Bijok
  • Fonction : Auteur
Aurélien Rohn
  • Fonction : Auteur
Julie Bellet
  • Fonction : Auteur
Florence Lallemant
  • Fonction : Auteur
Nathalie Bruneau
  • Fonction : Auteur
Christine Ducam
  • Fonction : Auteur
Geoffrey Dagod
  • Fonction : Auteur
Pauline Deras
  • Fonction : Auteur
Xavier Capdevila
  • Fonction : Auteur
Magdalena Szczot
  • Fonction : Auteur
Alain Meyer
  • Fonction : Auteur
Stéphane Hecketsweiler
  • Fonction : Auteur
Etienne Escudier
  • Fonction : Auteur
Michel Muller
  • Fonction : Auteur
Samuel Gray
  • Fonction : Auteur
Magalie Farines
  • Fonction : Auteur
Marie Lebouc
  • Fonction : Auteur
Sophie Debord-Pedet
  • Fonction : Auteur

Résumé

Importance Optimal transfusion strategies in traumatic hemorrhage are unknown. Reports suggest a beneficial effect of 4-factor prothrombin complex concentrate (4F-PCC) on blood product consumption. Objective To investigate the efficacy and safety of 4F-PCC administration in patients at risk of massive transfusion. Design, Setting, and Participants Double-blind, randomized, placebo-controlled superiority trial in 12 French designated level I trauma centers from December 29, 2017, to August 31, 2021, involving consecutive patients with trauma at risk of massive transfusion. Follow-up was completed on August 31, 2021. Interventions Intravenous administration of 1 mL/kg of 4F-PCC (25 IU of factor IX/kg) vs 1 mL/kg of saline solution (placebo). Patients, investigators, and data analysts were blinded to treatment assignment. All patients received early ratio-based transfusion (packed red blood cells:fresh frozen plasma ratio of 1:1 to 2:1) and were treated according to European traumatic hemorrhage guidelines. Main Outcomes and Measures The primary outcome was 24-hour all blood product consumption (efficacy); arterial or venous thromboembolic events were a secondary outcome (safety). Results Of 4313 patients with the highest trauma level activation, 350 were eligible for emergency inclusion, 327 were randomized, and 324 were analyzed (164 in the 4F-PCC group and 160 in the placebo group). The median (IQR) age of participants was 39 (27-56) years, Injury Severity Score was 36 (26-50 [major trauma]), and admission blood lactate level was 4.6 (2.8-7.4) mmol/L; prehospital arterial systolic blood pressure was less than 90 mm Hg in 179 of 324 patients (59%), 233 patients (73%) were men, and 226 (69%) required expedient hemorrhage control. There was no statistically or clinically significant between-group difference in median (IQR) total 24-hour blood product consumption (12 [5-19] U in the 4F-PCC group vs 11 [6-19] U in the placebo group; absolute difference, 0.2 U [95% CI, −2.99 to 3.33]; P = .72). In the 4F-PCC group, 56 patients (35%) presented with at least 1 thromboembolic event vs 37 patients (24%) in the placebo group (absolute difference, 11% [95% CI, 1%-21%]; relative risk, 1.48 [95% CI, 1.04-2.10]; P = .03). Conclusions and Relevance Among patients with trauma at risk of massive transfusion, there was no significant reduction of 24-hour blood product consumption after administration of 4F-PCC, but thromboembolic events were more common. These findings do not support systematic use of 4F-PCC in patients at risk of massive transfusion. Trial Registration ClinicalTrials.gov Identifier: NCT03218722

Dates et versions

hal-04432298 , version 1 (01-02-2024)

Identifiants

Citer

Pierre Bouzat, Jonathan Charbit, Paer-Selim Abback, Delphine Huet-Garrigue, Nathalie Delhaye, et al.. Efficacy and Safety of Early Administration of 4-Factor Prothrombin Complex Concentrate in Patients With Trauma at Risk of Massive Transfusion. JAMA Cardiology, 2023, 329 (16), pp.1367. ⟨10.1001/jama.2023.4080⟩. ⟨hal-04432298⟩
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