Pilot Study of Whole Blood Transfusion for Trauma Brain Injury (TBI)

Study Overview
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Brief Summary
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Our goal is to perform a pilot, single center study to evaluate the efficacy of whole blood (WB) in subjects with TBI, intracranial hemorrhage, and anemia compared to blood component therapy.

Detailed Description
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Both whole blood and blood components are given as standard-of-care based on the blood products available. If enrolled in this study, patients will be randomized 1:1 to receive either whole blood or blood components first. They will continue to receive blood products based on their assigned group. If they require more blood product than is available, they will cross over to the other group so they can continue to receive the transfusions needed for treatment. The primary endpoint for this study would be improvement in coagulopathy pre and post intervention. Additionally, we will evaluate hemorrhagic progression of the intracranial bleed (HPIB), as measured by follow-up CT scan ordered over the first 24-hour post intervention (which is standard of care). The secondary outcomes parameters would include intracranial pressure measurements (if performed), survival to discharge, safety and tolerability of Whole Blood administration in the TBI population, coagulation parameters and total blood product use, Glasgow Coma Scale (GCS) 24 hours post-injury, in-hospital mortality, and patient's discharge status (Glasgow Outcome Score Extended and disposition to home versus extended care facility). Patients who decide to take part in the study, will have 26 mL of blood drawn (about 2 tablespoons) once before and once after blood transfusion for a total of 52 mL (about 4 tablespoons) of blood drawn, a CT scan at admission and at 24hour of blood transfusion, and information will be gathered from their medical record during their hospital stay.

Official Title
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Pilot Study of Whole Blood Transfusion for Trauma Brain Injury (TBI)

Conditions
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Traumatic Brain Injury

Intervention / Treatment
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* Biological: Whole blood transfusion
* Biological: Blood components transfusion


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 15 years and older Head CT with presence of intracranial bleeding Required transfusion of whole blood (WB) or red blood cells (RBC) Exclusion Criteria: Patients with non-survivable injuries (expected to die within 24-hours of injury) Fixed and dilated pupils Patients requiring a massive transfusion protocol activation Receipt of 2 units of WB or RBCs prior to enrollment Known prisoners Known pregnancy

Ages Eligible for Study
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Minimum Age: 15 Years
Maximum Age: 120 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: Pilot, single center, and a randomized 1:1 trial.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Whole Blood Transfusion<br>Transfusion of whole blood units | Biological: Whole blood transfusion<br>* The transfusion of whole blood units<br>|
| Active Comparator: Blood Component Transfusion<br>Transfusion of blood components units | Biological: Blood components transfusion<br>* The transfusion of blood components units rather than whole blood<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mortality and Morbidity | The primary outcome for this study would be Glasgow Outcome Coma Scale score at discharge. | Up to 30 days after hospital admission | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Improvement in Coagulopathy | The secondary outcome for this study would be improvement in coagulopathy pre and post intervention. We will evaluate hemorrhagic progression of the intracranial bleed (HPIB), as measured by follow-up CT scan ordered over the first 24-hour post intervention (which is standard of care). | Up to 30 days after hospital admission |