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

NCT04431999 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 200

Last updated 2026-01-26

No results posted yet for this study

Summary

The prognosis of traumatized hemorrhages is correlated with the nature of transfusion therapy: a 50% reduction in mortality for an early and massive supply of plasma, and 20% for an early and massive supply of platelets. However, this strategy encounters logistical difficulties, particularly in a context of collective emergency (attacks). The use of whole blood, widely documented by the Armed Forces, improves the availability of plasma and platelets, and simplifies handling by the various actors in the chain.

T-STORHM is a randomized, controlled, parallel clinical trial.This study tests non-inferiority of whole blood transfusion therapy in the management of coagulopathy in patients with acute traumatic hemorrhage.

Conditions

  • Trauma
  • Acute Hemorrhage
  • Coagulopathy

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.

Sponsors & Collaborators

  • TIMC-IMAG

    collaborator OTHER

  • Floralis

    collaborator INDUSTRY

  • Direction Centrale du Service de Santé des Armées

    lead OTHER

Principal Investigators

  • Guillaume PELÉE DE SAINT MAURICE · Direction Centrale du Service de Santé des Armées (DCSSA)

  • Sylvain AUSSET · Institution Nationale des Invalides

  • Jean-Luc BOSSON · Statistical and methodological investigator - Laboratoire TIMC UMR 5525 CNRS Equipe Themas

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-12-04
Primary Completion
2025-10-17
Completion
2025-10-20

Countries

  • France

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04431999 on ClinicalTrials.gov