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

NCT ID: NCT04431999

Last Updated: 2026-01-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-12-04
• Study Completion Date: 2025-10-20

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.

Detailed 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.

Conditions

Trauma; Acute Hemorrhage; Coagulopathy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Whole blood group

Damage control resuscitation for trauma care using whole blood.

Group Type: EXPERIMENTAL

Whole blood transfusion

Intervention Type: 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.

Fractionated blood products group

Damage control resuscitation for trauma care using component therapy.

Group Type: ACTIVE_COMPARATOR

Fractionated blood products transfusion

Intervention Type: 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.

Interventions

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.

Intervention Type: 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.

Intervention Type: DRUG

Eligibility Criteria

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

2. 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

3. 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

Exclusion Criteria

• 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...)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

TIMC-IMAG

OTHER

Sponsor Role: collaborator

Floralis

INDUSTRY

Sponsor Role: collaborator

Direction Centrale du Service de Santé des Armées

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Guillaume PELÉE DE SAINT MAURICE

Role: STUDY_DIRECTOR

Direction Centrale du Service de Santé des Armées (DCSSA)

Sylvain AUSSET

Role: PRINCIPAL_INVESTIGATOR

Institution Nationale des Invalides

Jean-Luc BOSSON

Role: PRINCIPAL_INVESTIGATOR

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

Locations

CHU de La Cavale Blanche - Brest

Brest, , France

HIA Percy

Clamart, , France

CHU de Grenoble

Grenoble, , France

CHU de La Pitié-Salpêtrière

Paris, , France

CHU du Kremlin Bicêtre

Paris, , France

HIA Sainte Anne

Toulon, , France

Countries

France

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Other Identifiers

2019-A02706-51

Identifier Type: -

Identifier Source: org_study_id