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

• Status: Not yet recruiting
• Trial end date: 2024-06-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Direction Centrale du Service de Santé des Armées
• Collaborators: Floralis; TIMC-IMAG

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 on the prediction of the practitioner (clinical diagnosis) in charge of the treatment of the injured person of the need to transfuse at least 4 PRBCs within 6 hours after the admission of the trauma patient

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).

• No affiliated to the social security

• Person deprived of liberty by a legal or administrative decision, person under guardianship