Recruitment

Recruitment Status
Not yet recruiting
Estimated Enrollment
Same as current

Summary

Conditions
  • Acute Hemorrhage
  • Coagulopathy
  • Trauma
Type
Interventional
Phase
Phase 3
Design
Allocation: RandomizedIntervention Model: Parallel AssignmentIntervention Model Description: Multicenter, Controlled, Randomized, Open Labe Therapeutic TrialMasking: None (Open Label)Primary Purpose: Treatment

Participation Requirements

Age
Between 18 years and 125 years
Gender
Both males and females

Description

In recent years, terrorist attacks have confronted the investigator's healthcare system with a massive influx of victims of war weapon injuries. This new fact makes the efficiency of transfusion therapy crucial: hemorrhage is the leading cause of death from weapons of war, and the high number of vic...

In recent years, terrorist attacks have confronted the investigator's healthcare system with a massive influx of victims of war weapon injuries. This new fact makes the efficiency of transfusion therapy crucial: hemorrhage is the leading cause of death from weapons of war, and the high number of victims of each attack changes the logistical approach. The logistical problems with transfusion therapy, including red blood cell (PRBCs), plasma and platelet concentrates, are the speed of delivery and availability. Using whole blood is a pragmatic solution to overcome these problems. This solution has been used for many years by the French Army to ensure platelet transfusion in traumatic hemorrhages The hypothesis of the T-STORHM study is that the use of whole blood is a solution in a context of civil trauma not effective less than component therapy (PRBCs, plasma and platelet concentrates) in the management of coagulopathy in patients admitted to hospital for traumatic hemorrhage.

Tracking Information

NCT #
NCT04431999
Collaborators
  • TIMC-IMAG
  • Floralis
Investigators
Study Director: Hervé FOEHRENBACH Direction Centrale du Service de Santé des Armées (DCSSA) Principal Investigator: Sylvain AUSSET Ecoles militaires de santé de Lyon-Bron Principal Investigator: Jean-Luc BOSSON Statistical and methodological investigator - Laboratoire TIMC UMR 5525 CNRS Equipe Themas