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

Trials

for the PREHO-PLYO Study Group¹  Emilie Louis-Delauriere²  Catherine Verret²  Anne Sailliol³  Eliane Garrabe³  Sylvain Ausset³  Christophe Martinaud³  Frederic Lemoine⁴  Romain Jouffroy⁴  Stéphane Travers⁴  Sabine Lemoine⁴  Ludovic Delhaye⁴  Nicolas Hervault⁴  Clément Derkenne⁴  Vivien Hong Tuan Ha⁴  Edouard Seguineau⁴  Pascal Dang-Minh⁴  Nicolas Pouliquen⁴  René Bihannic⁴  Olga Maurin⁴  Maëlle Delacote⁴  Julie Trichereau⁴  Benoit Frattini⁴  Michel Bignand⁴  Bertrand Prunet⁴  Jean Pierre Tourtier⁴  Vincent Lanoe⁴  Anne Godefroy⁴  Marina Salomé⁴  Marilyn Franchin Frattini⁴  Daniel Jost⁴  Florian Roquet⁴ 

[1] ;Department of Education, Research and Innovation, Service de Santé des Armées;French Military Health Service, Val de Grâce military hospital;Paris Fire Brigade Medical Emergency Department;

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

DOI  :  10.1186/s13063-020-4049-1

来源: DOAJ

【 摘 要 】

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).

【 授权许可】

Unknown