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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Trauma, Acute Hemorrhage, Coagulopathy

Intervention / Treatment
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* Drug: Whole blood transfusion
* Drug: Fractionated blood products transfusion


Participation Criteria
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Eligibility Criteria
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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). Patient under specific known transfusion protocol (for example : allo immunization...)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Multicenter, Controlled, Randomized, Open Labe Therapeutic Trial
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Whole blood group<br>Damage control resuscitation for trauma care using whole blood. | Drug: Whole blood transfusion<br>* 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.<br>|
| Active Comparator: Fractionated blood products group<br>Damage control resuscitation for trauma care using component therapy. | Drug: Fractionated blood products transfusion<br>* 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.<br>|

What is the study measuring?
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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). | 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 | Proportion of patients with lactate clearance > 20% per hour at H2. | 2 hours following hospital admission | 
| Mortality | Number of deaths. | 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. | 24 hours following hospital admission | 
| Impact on timeframe to obtain blood products | Time to obtain product ratios in accordance with recommendations. | 2 and 6 hours following hospital admission | 
| Impact on time to start transfusion therapy | Time to start transfusion therapy. | Time between admission and transfusion therapy | 
| Evolution of coagulopathy. | 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 | 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 | Hemolysis marker rate | Day 1, Day 2 | 
| Labile blood products transfused in the first 24 hours | Number of bags administered | 24 hours following hospital admission | 
| Cost of the strategy | Direct costs of transfusion and the cost of the ICU stay | Day 30 (or the last day of hospitalization) | 
| Biobank establishment | 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 | 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. | Optical imaging technique of microvascular content to detect flow anomalies in microvessels. | During the transfusion resuscitation | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Whole Blood, Acute traumatic coagulopathy, Transfusion