Evaluation of a Transfusion Therapy Using Whole Blood in the Management of Coagulopathy in Patients with Acute Traumatic Hemorrhage (T-STORHM)

Direction Centrale du Service de Santé des Armées

Status and phase: Enrolling; Phase 3

Conditions: Coagulopathy; Acute Hemorrhage; Trauma

Treatments: Drug: Whole blood transfusion; Drug: Fractionated blood products transfusion

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT04431999

2019-A02706-51

Details and patient eligibility

About

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.

Full 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.

Enrollment: 200 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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...)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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200 participants in 2 patient groups

Whole blood group

Experimental group

Description:

Damage control resuscitation for trauma care using whole blood.

Treatment:

Drug: Whole blood transfusion

Fractionated blood products group

Active Comparator group

Description:

Damage control resuscitation for trauma care using component therapy.

Treatment:

Drug: Fractionated blood products transfusion