French lyophilized plasma versus normal saline for post-traumatic coagulopathy prevention and correction: PREHO-PLYO protocol for a multicenter randomized controlled clinical trial

Daniel Jost, Sabine Lemoine, Frederic Lemoine, Vincent Lanoe, Olga Maurin, Clément Derkenne, Marilyn Franchin Frattini, Maëlle Delacote, Edouard Seguineau, Anne Godefroy, Nicolas Hervault, Ludovic Delhaye, Nicolas Pouliquen, Emilie Louis-Delauriere, Julie Trichereau, Florian Roquet, Marina Salomé, Catherine Verret, René Bihannic, Romain Jouffroy, Benoit Frattini, Vivien Hong Tuan Ha, Pascal Dang-Minh, Stéphane Travers, Michel Bignand, Christophe Martinaud, Eliane Garrabe, Sylvain Ausset, Bertrand Prunet, Anne Sailliol, Jean Pierre Tourtier, PREHO-PLYO Study Group, Daniel Jost, Sabine Lemoine, Frederic Lemoine, Vincent Lanoe, Olga Maurin, Clément Derkenne, Marilyn Franchin Frattini, Maëlle Delacote, Edouard Seguineau, Anne Godefroy, Nicolas Hervault, Ludovic Delhaye, Nicolas Pouliquen, Emilie Louis-Delauriere, Julie Trichereau, Florian Roquet, Marina Salomé, Catherine Verret, René Bihannic, Romain Jouffroy, Benoit Frattini, Vivien Hong Tuan Ha, Pascal Dang-Minh, Stéphane Travers, Michel Bignand, Christophe Martinaud, Eliane Garrabe, Sylvain Ausset, Bertrand Prunet, Anne Sailliol, Jean Pierre Tourtier, PREHO-PLYO Study Group

Abstract

Background: Post-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/design: This 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.

Conclusion: With 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 registration: ClinicalTrials.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).

Keywords: Advanced trauma life support; Hemorrhagic shock; Lyophilized plasma transfusion; Post-trauma coagulopathy; Prehospital emergency care; Shock index.

Conflict of interest statement

The authors declare that they have no competing interests to declare.

Figures

Fig. 1
Fig. 1
Study flow (CONSORT) for the PREHO PLYO trial. SBP systolic blood pressure, FLYP French lyophilised plasma, ICU intensive care unit
Fig. 2
Fig. 2
Inclusion rate up to the first 114 patients (1 July 2019). Allocation of the last of the 140 patients is anticipated to be in late October 2019. The broken lines represent the expected inclusion rate; the solid line represents included patients

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Source: PubMed

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