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

Sponsor

Direction Centrale du Service de Santé des Armées (Other)

Overall Status

Recruiting

CT.gov ID

NCT04431999

Collaborator

TIMC-IMAG (Other), Floralis (Industry)

200

Enrollment

Locations

Arms

32.9

Anticipated Duration (Months)

33.3

Patients Per Site

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Trauma Acute Hemorrhage Coagulopathy	Drug: Whole blood transfusion Drug: Fractionated blood products transfusion	Phase 3

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 Design

Study Type:

Interventional

Anticipated Enrollment :

200 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

Multicenter, Controlled, Randomized, Open Labe Therapeutic TrialMulticenter, Controlled, Randomized, Open Labe Therapeutic Trial

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Dec 4, 2021

Anticipated Primary Completion Date :

Sep 1, 2023

Anticipated Study Completion Date :

Sep 1, 2024

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

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

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°1 : recirculation of storage microerythrocytes [before and after transfusion resuscitation, Day 30 (or the last day of hospitalization).]
Rate of storage microerythrocytes, monocyte quantification and phenotyping, splenic ultrasound
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

Severe trauma patients requiring the initiation of a massive transfusion protocol determined on

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

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

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

Contacts and Locations

Locations

	Site	City	Country	Postal Code
1	CHU de La Cavale Blanche - Brest	Brest	France	29200
2	HIA Percy	Clamart	France	92140
3	CHU de Grenoble	Grenoble	France	38000
4	CHU de La Pitié-Salpêtrière	Paris	France	75013
5	CHU du Kremlin Bicêtre	Paris	France	94270
6	HIA Sainte Anne	Toulon	France	83000

Sponsors and Collaborators

Direction Centrale du Service de Santé des Armées
TIMC-IMAG
Floralis

Investigators

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