Evaluation of a Transfusion Therapy Using Whole Blood in the Management of Coagulopathy in Patients with Acute Traumatic Hemorrhage

PHASE3RecruitingINTERVENTIONAL
Enrollment

200

Participants

Timeline

Start Date

December 4, 2021

Primary Completion Date

December 31, 2025

Study Completion Date

January 31, 2026

Conditions
TraumaAcute HemorrhageCoagulopathy
Interventions
DRUG

Whole blood transfusion

Severe trauma patients with a life threatening bleeding will be managed with 3 whole blood bags for the 1st and 2nd pack. The later packs will consist of 3 packed red blood cells (PRBCs), 3 plasma units and 1 dose of platelets.

DRUG

Fractionated blood products transfusion

Severe trauma patients with a life threatening bleeding will be managed with 3 packed red blood cells (PRBCs), 3 lyophilised plasma units and 1 dose of platelets for the 1st. The 2nd pack will consist of 3 packed red blood cells (PRBCs) and 3 lyophilised plasma units. Then, the later pack will consist of 3 packed red blood cells (PRBCs), 3 plasma units and 1 dose of platelets.

Trial Locations (6)

29200

RECRUITING

CHU de La Cavale Blanche - Brest, Brest

38000

RECRUITING

CHU de Grenoble, Grenoble

75013

RECRUITING

CHU de La Pitié-Salpêtrière, Paris

83000

RECRUITING

HIA Sainte Anne, Toulon

92140

RECRUITING

HIA Percy, Clamart

94270

RECRUITING

CHU du Kremlin Bicêtre, Paris

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

TIMC-IMAG

OTHER

collaborator

Floralis

INDUSTRY

lead

Direction Centrale du Service de Santé des Armées

OTHER

NCT04431999 - Evaluation of a Transfusion Therapy Using Whole Blood in the Management of Coagulopathy in Patients with Acute Traumatic Hemorrhage | Biotech Hunter | Biotech Hunter