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

NCT04431999 | Completed Phase 3 DMC

• 1 other identifier: 2019-A02706-51
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 6

Brief 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

Keywords

Whole Blood; Acute traumatic coagulopathy; Transfusion

Outcome Measures

Primary Outcomes (1)

• Non inferiority on the correction of coagulopathy, during emergency transfusion of bleeding trauma using whole blood compared to the use of component therapy (packed red blood cells, plasma units and platelets).

  This outcome is measured on the correction of traumatic coagulopathy, measured by the value of a viscoelastometric parameter : the maximum amplitude (MA) (measured by a thromboelastogram).

  6 hours following hospital admission

Secondary Outcomes (11)

• Effectiveness of circulatory resuscitation

  2 hours following hospital admission

• Mortality

  2 hours following hospital admission and Day 30 (or the last day of hospitalization)

• Mortality / Morbidity

  24 hours following hospital admission

• Impact on timeframe to obtain blood products

  2 and 6 hours following hospital admission

• Impact on time to start transfusion therapy

  Time between admission and transfusion therapy

Study Arms (2)

Whole blood group

EXPERIMENTAL

Damage control resuscitation for trauma care using whole blood.

Drug: Whole blood transfusion

Fractionated blood products group

ACTIVE COMPARATOR

Damage control resuscitation for trauma care using component therapy.

Drug: Fractionated blood products transfusion

Interventions

Whole blood transfusion DRUG

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.

Whole blood group

Fractionated blood products transfusion DRUG

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.

Fractionated blood products group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Severe trauma patients requiring the initiation of a massive transfusion protocol determined on
• 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
• AND at least two criteria of the Assessment of Blood Consumption (ABC) score established at the patient's arrival:
• Penetrating trauma
• Focused Abdominal Sonography for Trauma (FAST) echo positive
• Blood pressure \<90 mmHg
• Respiratory rate \>120 bpm
• AND/OR after clinical assessment and on the prediction of the practitioner in charge of the treatment of the injured person of the need to transfuse during the emergency management of the injured person

You may not qualify if:

• Non-traumatic hemorrhage
• Patients transfused with more than two PRBCs before the initiation of the massive transfusion 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 : allo immunization...)

Sponsors & Collaborators

• TIMC-IMAG: collaborator
• Floralis: collaborator
• Direction Centrale du Service de Santé des Armées: lead

Study Sites (6)

CHU de La Cavale Blanche - Brest

Brest, 29200, France

Location

HIA Percy

Clamart, 92140, France

Location

CHU de Grenoble

Grenoble, 38000, France

Location

CHU de La Pitié-Salpêtrière

Paris, 75013, France

Location

CHU du Kremlin Bicêtre

Paris, 94270, France

Location

HIA Sainte Anne

Toulon, 83000, France

Location

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MeSH Terms

Conditions

Wounds and Injuries; Hemostatic Disorders

Interventions

Exchange Transfusion, Whole Blood

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Hemorrhagic Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Blood Transfusion; Biological Therapy; Therapeutics

Study Officials

• Guillaume PELÉE DE SAINT MAURICE

  Direction Centrale du Service de Santé des Armées (DCSSA)

  STUDY DIRECTOR

• Sylvain AUSSET

  Institution Nationale des Invalides

  PRINCIPAL INVESTIGATOR

• Jean-Luc BOSSON

  Statistical and methodological investigator - Laboratoire TIMC UMR 5525 CNRS Equipe Themas

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Multicenter, Controlled, Randomized, Open Labe Therapeutic Trial

Study Record Dates

• First Submitted: May 28, 2020
• First Posted: June 16, 2020
• Study Start: December 4, 2021
• Primary Completion: October 17, 2025
• Study Completion: October 20, 2025
• Last Updated: January 26, 2026

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

FR (6)