Pre-hospital Administration of Lyophilized Plasma for Post-traumatic Coagulopathy Treatment (PREHO-PLYO)

Summary

In severe bleeding due to trauma, a decrease in coagulation factors maintains and promotes bleeding. The plasma allows, through its contribution of coagulation factors, early prevention or correction of this post-trauma induced coagulopathy. This study aims to measure the effectiveness of pre-hospital FLYP administration in case of traumatic hemorrhagic shock, in the occurrence or the treatment of a post traumatic induced coagulopathy.

Study Design

This is a randomized controlled multicenter open label study in two parallel groups.

Eligibility criteria : adult, victim of a hemorrhagic shock of traumatic origin with \[systolic blood pressure \<70 mmHg\] or Shock Index \>1.1 The patients will receive either FLYP either the usual treatment as given in the recommendations for best practice.

The primary endpoint is the International Normalized Ratio (INR) at hospital admission.

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 they received.

Conditions

• Shock Hemorrhagic

Interventions

BIOLOGICAL

French Lyophilized Plasma

During the pre-hospital phase, the main events related to this arm are * Blood samples taken before treatment (TP, fibrinogen, platelets, RBC, grouping) * Usual pre-hospital care according to recommendations in best practices * Administration of FLYP

BIOLOGICAL

Normale Saline Solution

During the pre-hospital phase, the main events related to this arm are * Blood samples taken before treatment (TP, fibrinogen, platelets, RBC, grouping) * Usual pre-hospital care according to recommendations in best practices * Administration of Normale Saline Solution

Sponsors & Collaborators

• Bataillon des marins pompiers de Marseille, France

  collaborator UNKNOWN

• Military Hospital Laveran,Marseille, France

  collaborator UNKNOWN

• Samu of Marseille, France

  collaborator UNKNOWN

• Samu of Lyon, France

  collaborator UNKNOWN

• Lyon-South Hospital, France

  collaborator UNKNOWN

• Hôpital Edouard Herriot

  collaborator OTHER

• Fire Brigade Of Paris Emergency Medicine Dept

  collaborator OTHER

• CH Annecy Genevois

  collaborator OTHER

• Institut de Recherche Biomedicale des Armees

  collaborator OTHER_GOV

• Marseille North Hospital, France

  collaborator UNKNOWN

• Samu of Necker, Paris, France

  collaborator UNKNOWN

• Samu of Annecy, France

  collaborator UNKNOWN

• Military Hospital Percy , Clamart, France

  collaborator UNKNOWN

• Military Hospital Begin, Saint-Mandé, France

  collaborator UNKNOWN

• Centre de transfusion sanguine des Armées, Clamart, France

  collaborator UNKNOWN

• Henri Mondor University Hospital

  collaborator OTHER

• Samu of Beaujon, Clichy-La-Garenne, France

  collaborator UNKNOWN

• Samu of Lariboisière, Paris, France

  collaborator UNKNOWN

• Samu of Henri Mondor, Créteil, France

  collaborator UNKNOWN

• Samu of Brest, Brest , France

  collaborator UNKNOWN

• Samu of Pau , Pau , France

  collaborator UNKNOWN

• French Defence Health Service

  lead OTHER_GOV

Principal Investigators

• Jean-Pierre TOURTIER, Professor · Fire Brigade Of Paris Emergency Medicine Dept

• Daniel JOST, MD · Fire Brigade Of Paris Emergency Medicine Dept

• Anne SAILLIOL, Professor · Centre de Transfusion Sanguine des Armées

• Catherine VERRET, MD · Institut de recherche biomedicale des armées

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2016-04-01

Primary Completion

2019-10-31

Completion

2019-11-30

Countries

• France

Study Locations