Clinical trial NCT04431999: Evaluation of a Transfusion Therapy Using Whole Blood in the Management of Coagulopathy in Patients with Acute Traumatic Hemorrhage
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Trauma
Acute Hemorrhage
Coagulopathy
Keywords: Whole Blood
Acute traumatic coagulopathy
Transfusion
Lead sponsor: Direction Centrale du Service de Santé des Armées
Sponsor class: OTHER
Collaborators: name: TIMC-IMAG
name: Floralis
First posted: 2020-06-16
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Multicenter, Controlled, Randomized, Open Labe Therapeutic Trial
Primary purpose: TREATMENT

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.

Eligibility criteria: 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...)

Primary outcomes:
measure: 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).
timeFrame: 6 hours following hospital admission
Secondary outcomes:
measure: Effectiveness of circulatory resuscitation
timeFrame: 2 hours following hospital admission
measure: Mortality
timeFrame: 2 hours following hospital admission and Day 30 (or the last day of hospitalization)
measure: Mortality / Morbidity
timeFrame: 24 hours following hospital admission
measure: Impact on timeframe to obtain blood products
timeFrame: 2 and 6 hours following hospital admission
measure: Impact on time to start transfusion therapy
timeFrame: Time between admission and transfusion therapy
measure: Evolution of coagulopathy.
timeFrame: At inclusion, 2, 6 and 24 hours following hospital admission
measure: Evolution of coagulopathy
timeFrame: At inclusion, 2, 6 and 24 hours following hospital admission.
measure: Tolerance of whole blood transfusion
timeFrame: Day 1, Day 2
measure: Labile blood products transfused in the first 24 hours
timeFrame: 24 hours following hospital admission
measure: Cost of the strategy
timeFrame: Day 30 (or the last day of hospitalization)
measure: Biobank establishment
timeFrame: Through study completion, an average of 3 years
measure: Ancillary study n°2 : evolution of microcirculation during transfusion resuscitation of hemorrhagic shock.
timeFrame: During the transfusion resuscitation
Other outcomes:
Locations:
city: Brest
country: France
facility: CHU de La Cavale Blanche - Brest
city: Clamart
country: France
facility: HIA Percy
city: Grenoble
country: France
facility: CHU de Grenoble
city: Paris
country: France
facility: CHU de La Pitié-Salpêtrière
city: Paris
country: France
facility: CHU du Kremlin Bicêtre
city: Toulon
country: France
facility: HIA Sainte Anne
Study officials:
affiliation: Direction Centrale du Service de Santé des Armées (DCSSA)
name: Guillaume PELÉE DE SAINT MAURICE
role: STUDY_DIRECTOR
affiliation: Institution Nationale des Invalides
name: Sylvain AUSSET
role: PRINCIPAL_INVESTIGATOR
affiliation: Statistical and methodological investigator - Laboratoire TIMC UMR 5525 CNRS Equipe Themas
name: Jean-Luc BOSSON
role: PRINCIPAL_INVESTIGATOR
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