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,
for the PREHO-PLYO Study Group
Affiliations
Daniel Jost
Paris Fire Brigade Medical Emergency Department
Sabine Lemoine
Paris Fire Brigade Medical Emergency Department
Frederic Lemoine
Paris Fire Brigade Medical Emergency Department
Vincent Lanoe
Paris Fire Brigade Medical Emergency Department
Olga Maurin
Paris Fire Brigade Medical Emergency Department
Clément Derkenne
Paris Fire Brigade Medical Emergency Department
Marilyn Franchin Frattini
Paris Fire Brigade Medical Emergency Department
Maëlle Delacote
Paris Fire Brigade Medical Emergency Department
Edouard Seguineau
Paris Fire Brigade Medical Emergency Department
Anne Godefroy
Paris Fire Brigade Medical Emergency Department
Nicolas Hervault
Paris Fire Brigade Medical Emergency Department
Ludovic Delhaye
Paris Fire Brigade Medical Emergency Department
Nicolas Pouliquen
Paris Fire Brigade Medical Emergency Department
Emilie Louis-Delauriere
Department of Education, Research and Innovation, Service de Santé des Armées
Julie Trichereau
Paris Fire Brigade Medical Emergency Department
Florian Roquet
Paris Fire Brigade Medical Emergency Department
Marina Salomé
Paris Fire Brigade Medical Emergency Department
Catherine Verret
Department of Education, Research and Innovation, Service de Santé des Armées
René Bihannic
Paris Fire Brigade Medical Emergency Department
Romain Jouffroy
Paris Fire Brigade Medical Emergency Department
Benoit Frattini
Paris Fire Brigade Medical Emergency Department
Vivien Hong Tuan Ha
Paris Fire Brigade Medical Emergency Department
Pascal Dang-Minh
Paris Fire Brigade Medical Emergency Department
Stéphane Travers
Paris Fire Brigade Medical Emergency Department
Michel Bignand
Paris Fire Brigade Medical Emergency Department
Christophe Martinaud
French Military Health Service, Val de Grâce military hospital
Eliane Garrabe
French Military Health Service, Val de Grâce military hospital
Sylvain Ausset
French Military Health Service, Val de Grâce military hospital
Bertrand Prunet
Paris Fire Brigade Medical Emergency Department
Anne Sailliol
French Military Health Service, Val de Grâce military hospital
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).
