Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional
Official Title: Interest of Pre-hospital Administration of Lyophilized Plasma to Prevent or Treat Coagulopathy Associated With Post-traumatic Hemorrhagic Shock (PREHO-PLYO Study )
Brief Summary:
In severe bleeding due to trauma, a fall in coagulation factors maintains and promotes bleeding. The plasma allows, through its contribution of coagulation factors, early prevention or correction of this post-traumatic coagulopathy. The main objective is to show the effectiveness of pre-hospital administered FLYP during treatment of a traumatic hemorrhagic shock, in the occurrence or the treatment of a post traumatic coagulopathy.
Study Design
This is a Randomized controlled multicenter open study in two parallel groups. Eligibility criteria : adult, victim of a hemorrhagic shock of traumatic origin with [systolic blood pressure <70 mmHg] or [systolic blood pressure between 71 and 90 mmHg AND heart rate > 108], or Shock Index >1.3 at some point in the medicalized care. Two groups of 70 patients will receive either FLYP+ the usual treatment for post traumatic hemorrhagic shock as given in the recommendations for best practice, or saline perfusion but no FLYP, as given in the recommendations for best practice. The primary endpoint is the variation in the level of Prothrombin (PR), between the PR at hospital admission and the PR originally taken in the pre-hospital period.- The secondary endpoints are: compilation of technical and logistical difficulties encountered before, during and after administration of FLYP ; the change in fibrinogen level between fibrinogen level at hospital admission and fibrinogen level originally taken in the pre-hospital period. The study must confirm the link between causality of early administration of plasma in improving post-traumatic coagulopathy. The study must show safe usage in out-of-hospital situations and the ability of medical staff to meet the requirements of the health authorities in terms of product use as well as in terms of traceability of the victims and the treatment the