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

May 16, 2023 updated by: Direction Centrale du Service de Santé des Armées

Evaluation of a Transfusion Therapy Using Whole Blood Versus Fractionated Blood Products in the Management of Coagulopathy in Patients Admitted to Hospital for Acute Traumatic Hemorrhage

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

200

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

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).
  • Patient under specific known transfusion protocol (for example : allo immunization...)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Whole blood group
Damage control resuscitation for trauma care using whole blood.
Drug: 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.
Active Comparator: Fractionated blood products group
Damage control resuscitation for trauma care using component therapy.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
Time Frame: 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).
6 hours following hospital admission

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Direction Centrale du Service de Santé des Armées

Collaborators

Floralis
TIMC-IMAG

Investigators

  • Principal Investigator: Sylvain AUSSET, Ecoles militaires de santé de Lyon-Bron
  • Study Director: Nathalie KOULMANN, Direction Centrale du Service de Santé des Armées (DCSSA)
  • Principal Investigator: Jean-Luc BOSSON, Statistical and methodological investigator - Laboratoire TIMC UMR 5525 CNRS Equipe Themas

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 4, 2021

Primary Completion (Anticipated)

September 1, 2024

Study Completion (Anticipated)

September 1, 2025

Study Registration Dates

First Submitted

May 28, 2020

First Submitted That Met QC Criteria

June 12, 2020

First Posted (Actual)

June 16, 2020

Study Record Updates

Last Update Posted (Actual)

May 17, 2023

Last Update Submitted That Met QC Criteria

May 16, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2019-A02706-51

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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