PLyo: Oui mais sans hémodilution par les crstalloïdes

Prehospital Lyophilized Plasma Transfusion for Trauma-Induced Coagulopathy in Patients at Risk for Hemorrhagic Shock. A Randomized Clinical Trial
Jost D. et Al.JAMA Netw Open. 2022;5(7):e2223619.

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Le recours au plasma fait partie de l'arsenal thérapeutique de la prise en charge des traumatisés sévères en choc hémorragique. Comme  l'étude REPHILL (1), Ce travail ne met pas en évidence d'amélioration de la survie à 28 jours. Les délais de transport et le degré d'hémodilution lié au recours aux solutés salés expliquent peut être cela (2)

 

Key Points

Question  Does prehospital transfusion of lyophilized plasma result in a lower incidence of trauma-induced coagulopathy at hospital admission compared with standard care with normal saline infusion in patients at risk for hemorrhagic shock after trauma?

Findings  This multicenter randomized clinical trial included 150 patients with trauma who were treated in a prehospital setting. Median international normalized ratio at hospital admission, massive transfusion rate, 30-day survival, and adverse events did not significantly differ between lyophilized plasma transfusion and standard care.

Meaning  These findings suggest that prehospital lyophilized plasma transfusion is a feasible and safe procedure for patients who are at risk for hemorrhagic shock, although there is a lack of evidence regarding its ability to prevent trauma-induced coagulopathy.

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.