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

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 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).

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PID https://www.doi.org/10.6084/m9.figshare.c.4827660.v1
PID https://www.doi.org/10.6084/m9.figshare.c.4827660
URL http://dx.doi.org/10.6084/m9.figshare.c.4827660.v1
URL http://dx.doi.org/10.6084/m9.figshare.c.4827660
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Author Jost, Daniel
Author Lemoine, Sabine
Author Lemoine, Frederic
Author Lanoe, Vincent
Author Maurin, Olga
Author Derkenne, Clément
Author Frattini, Marilyn Franchin
Author Delacote, Maëlle
Author Seguineau, Edouard
Author Godefroy, Anne
Author Hervault, Nicolas
Author Delhaye, Ludovic
Author Pouliquen, Nicolas
Author Louis-Delauriere, Emilie
Author Trichereau, Julie
Author Roquet, Florian
Author Salomé, Marina
Author Verret, Catherine
Author Bihannic, René
Author Jouffroy, Romain
Author Benoit Frattini
Author Ha, Vivien Hong Tuan
Author Dang-Minh, Pascal
Author Travers, Stéphane
Author Bignand, Michel
Author Martinaud, Christophe
Author Garrabe, Eliane
Author Ausset, Sylvain
Author Prunet, Bertrand
Author Sailliol, Anne
Author Tourtier, Jean
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Collected From Datacite
Hosted By figshare
Publication Date 2020-01-01
Publisher figshare
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Source https://science-innovation-policy.openaire.eu/search/other?orpId=dedup_wf_001::89a2ada5f228a5c8a896a1a1b0d46556
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Last Updated 20 December 2020, 03:03 (CET)
Created 20 December 2020, 03:03 (CET)