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

Phase 3

Recruiting

• Conditions: Coagulopathy; Acute Hemorrhage; Trauma
• Interventions: Drug: Fractionated blood products transfusion; Drug: Whole blood transfusion

• Registration Number: NCT04431999
• Lead Sponsor: Direction Centrale du Service de Santé des Armées

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.

Study Timeline

• Study First Submitted: 2020-05-28
• Study First Submitted QC: 2020-06-12
• Study First Posted: 2020-06-16
• Study Start: 2021-12-04
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-13
• Last Update Posted: 2025-02-17
• Primary Completion: 2025-12
• Study Completion: 2026-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 200

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...)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Fractionated blood products group	Fractionated blood products transfusion	Damage control resuscitation for trauma care using component therapy.
Whole blood group	Whole blood transfusion	Damage control resuscitation for trauma care using whole blood.

Primary Outcome Measures

Name	Time	Method
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).	6 hours following hospital admission	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).

Secondary Outcome Measures

Name	Time	Method
Effectiveness of circulatory resuscitation	2 hours following hospital admission	Proportion of patients with lactate clearance \> 20% per hour at H2.
Mortality	2 hours following hospital admission and Day 30 (or the last day of hospitalization)	Number of deaths.
Mortality / Morbidity	24 hours following hospital admission	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.
Impact on timeframe to obtain blood products	2 and 6 hours following hospital admission	Time to obtain product ratios in accordance with recommendations.
Impact on time to start transfusion therapy	Time between admission and transfusion therapy	Time to start transfusion therapy.
Evolution of coagulopathy.	At inclusion, 2, 6 and 24 hours following hospital admission	All the parameters of the thrombelastography (TEG) (R/CK, alpha/CK, MA/CRT, LY30/CK, FF/CRT) allow to evaluate the coagulopathy.
Evolution of coagulopathy	At inclusion, 2, 6 and 24 hours following hospital admission.	All the parameters of the coagulation (PT, APTT, fibrinogene) allow to evaluate the coagulopathy.
Tolerance of whole blood transfusion	Day 1, Day 2	Hemolysis marker rate
Labile blood products transfused in the first 24 hours	24 hours following hospital admission	Number of bags administered
Cost of the strategy	Day 30 (or the last day of hospitalization)	Direct costs of transfusion and the cost of the ICU stay
Biobank establishment	Through study completion, an average of 3 years	To constitute biobank for biological measurements in research hemorrhagic shock pathophysiology of transfusion resuscitation.
Ancillary study n°2 : evolution of microcirculation during transfusion resuscitation of hemorrhagic shock.	During the transfusion resuscitation	Optical imaging technique of microvascular content to detect flow anomalies in microvessels.

Trial Locations

Locations (6)

CHU de La Cavale Blanche - Brest; 🇫🇷 Brest, France

HIA Percy; 🇫🇷 Clamart, France

CHU de Grenoble; 🇫🇷 Grenoble, France

CHU du Kremlin Bicêtre; 🇫🇷 Paris, France

HIA Sainte Anne; 🇫🇷 Toulon, France

CHU de La Pitié-Salpêtrière; 🇫🇷 Paris, France