NCT06184828

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

• Status: Not Yet Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: Oregon Health and Science University · Academic / Other
• Sex: All
• Age: 15 Years – 120 Years
• Healthy volunteers: Accepted

Summary

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

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.

Conditions

• Traumatic Brain Injury

Interventions

Type	Name	Description
BIOLOGICAL	Whole blood transfusion	The transfusion of whole blood units
BIOLOGICAL	Blood components transfusion	The transfusion of blood components units rather than whole blood

Timeline

• Start date: 2024-08-01
• Primary completion: 2025-09-30
• Completion: 2025-09-30
• First posted: 2023-12-28
• Last updated: 2024-04-02