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

Last updated: February 13, 2025
Sponsor: Direction Centrale du Service de Santé des Armées
Overall Status: Active - Recruiting

Phase

3

Condition

Blood Clots

Hyponatremia

Hemorrhage

Treatment

Whole blood transfusion

Fractionated blood products transfusion

Clinical Study ID

NCT04431999
2019-A02706-51
  • Ages > 18
  • All Genders
  • Accepts Healthy Volunteers

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

Severe trauma patients requiring the initiation of a massive transfusion protocol determined on

  1. At least two Red flag score factors (according to pre-hospital data) :

  • Suspected pelvic fracture

  • Shock index (FC / PAS)> = 1

  • Microdose hemoglobin <13g

  • Average blood pressure <70 mmHg

  • Need for prehospital tracheal intubation

  1. AND at least two criteria of the Assessment of Blood Consumption (ABC) scoreestablished at the patient's arrival:

  • Penetrating trauma

  • Focused Abdominal Sonography for Trauma (FAST) echo positive

  • Blood pressure <90 mmHg

  • Respiratory rate >120 bpm

  1. AND/OR after clinical assessment and on the prediction of the practitioner in chargeof the treatment of the injured person of the need to transfuse during the emergencymanagement of the injured person

Exclusion

Exclusion Criteria:

  • Non-traumatic hemorrhage

  • Patients transfused with more than two PRBCs before the initiation of the massivetransfusion protocol.

  • Anti-coagulation treatment

  • Pregnancy

  • Age < 18 years

  • Patient refusing administration of blood products

  • Patient transferred from another hospital

  • Patient nor transported by a physician-staffed prehospital emergency medical system

  • Burn patient (≥30% of body surface).

  • Patient under specific known transfusion protocol (for example : alloimmunization...)

Study Design

Total Participants: 200
Treatment Group(s): 2
Primary Treatment: Whole blood transfusion
Phase: 3
Study Start date:
December 04, 2021
Estimated Completion Date:
January 31, 2026

Study 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 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.

Connect with a study center

  • CHU de La Cavale Blanche - Brest

    Brest, 29200
    France

    Active - Recruiting

  • HIA Percy

    Clamart, 92140
    France

    Active - Recruiting

  • CHU de Grenoble

    Grenoble, 38000
    France

    Active - Recruiting

  • CHU de La Pitié-Salpêtrière

    Paris, 75013
    France

    Active - Recruiting

  • CHU du Kremlin Bicêtre

    Paris, 94270
    France

    Active - Recruiting

  • HIA Sainte Anne

    Toulon, 83000
    France

    Active - Recruiting

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