Abstract
BackgroundPost-trauma bleeding induces an acute deficiency in clotting factors, which promotes bleeding and hemorrhagic shock. However, early plasma administration may reduce the severity of trauma-induced coagulopathy (TIC). Unlike fresh frozen plasma, which requires specific hospital logistics, French lyophilized plasma (FLYP) is storable at room temperature and compatible with all blood types, supporting its use in prehospital emergency care. We aim to test the hypothesis that by attenuating TIC, FLYP administered by prehospital emergency physicians would benefit the severely injured civilian patient at risk for hemorrhagic shock.Methods/designThis multicenter randomized clinical trial will include adults severely injured and at risk for hemorrhagic shock, with a systolic blood pressure < 70 mmHg or a Shock Index > 1.1. Two parallel groups of 70 patients will receive either FLYP or normal saline in addition to usual treatment. The primary endpoint is the International Normalized Ratio (INR) at hospital admission. Secondary endpoints are transfusion requirement, length of stay in the intensive care unit, survival rate at day 30, usability and safety related to FLYP use, and other biological coagulation parameters.ConclusionWith this trial, we aim to confirm the efficacy of FLYP in TIC and its safety in civilian prehospital care. The study results will contribute to optimizing guidelines for treating hemorrhagic shock in civilian settings.Trial registrationClinicalTrials.gov, NCT02736812. Registered on 13 April 2016. The trial protocol has been approved by the French ethics committee (CPP 3342) and the French Agency for the Safety of Medicines and Health Products (IDRCB 2015-A00866–43).
Highlights
Post-trauma bleeding induces an acute deficiency in clotting factors, which promotes bleeding and hemorrhagic shock
With this trial, we aim to confirm the efficacy of French lyophilized plasma (FLYP) in trauma-induced coagulopathy (TIC) and its safety in civilian prehospital care
The study results will contribute to optimizing guidelines for treating hemorrhagic shock in civilian settings
Summary
Post-trauma bleeding induces an acute deficiency in clotting factors, which promotes bleeding and hemorrhagic shock. Early plasma administration may reduce the severity of trauma-induced coagulopathy (TIC). We aim to test the hypothesis that by attenuating TIC, FLYP administered by prehospital emergency physicians would benefit the severely injured civilian patient at risk for hemorrhagic shock. Trauma-induced coagulopathy (TIC) occurs early after severe trauma, resulting from multiple and complex pathophysiological mechanisms [5]. The first phase consists of the activation of multiple hemostatic pathways in association with tissue damage and hypoperfusion. The third phase occurs post-resuscitation and leads to a prothrombotic state [6]. Three wellestablished factors correlate with mortality during traumatic shock: acidosis, hypothermia, and coagulopathy [9, 10]
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