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

Phase 3CompletedNCT04431999

Direction Centrale du Service de Santé des Armées200 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

200

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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...)

Locations (6)

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

Outcomes

Primary Outcomes

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).

Time frame: 6 hours following hospital admission

Secondary Outcomes

Effectiveness of circulatory resuscitation

Proportion of patients with lactate clearance \> 20% per hour at H2.

Time frame: 2 hours following hospital admission

Mortality

Number of deaths.

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

Mortality / Morbidity

Composite endpoint : Number of deaths at H24 or impairment of vital functions with a Sequential Organ Failure Assessment (SOFA) score greater than or equal to 12.

Time frame: 24 hours following hospital admission

Impact on timeframe to obtain blood products

Time to obtain product ratios in accordance with recommendations.

Time frame: 2 and 6 hours following hospital admission

Impact on time to start transfusion therapy

Time to start transfusion therapy.

Time frame: Time between admission and transfusion therapy

Evolution of coagulopathy.

All the parameters of the thrombelastography (TEG) (R/CK, alpha/CK, MA/CRT, LY30/CK, MA/CFF and TEG-ACT/CRT) allow to evaluate the coagulopathy.

Time frame: At inclusion, 2, 6 and 24 hours following hospital admission

Evolution of coagulopathy

All the parameters of the coagulation (PT, APTT, fibrinogene) allow to evaluate the coagulopathy.

Time frame: At inclusion, 2, 6 and 24 hours following hospital admission.

Tolerance of whole blood transfusion

Hemolysis marker rate

Time frame: Day 1, Day 2

Labile blood products transfused in the first 24 hours

Number of bags administered

Time frame: 24 hours following hospital admission

Cost of the strategy

Direct costs of transfusion and the cost of the ICU stay

Time frame: Day 30 (or the last day of hospitalization)

Biobank establishment

To constitute biobank for biological measurements in research hemorrhagic shock pathophysiology of transfusion resuscitation.

Time frame: Through study completion, an average of 3 years