Status:
NOT_YET_RECRUITING
Pilot Study of Whole Blood Transfusion for Trauma Brain Injury (TBI)
Lead Sponsor:
Oregon Health and Science University
Conditions:
Traumatic Brain Injury
Eligibility:
All Genders
15-120 years
Phase:
PHASE3
Brief 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 b...
Eligibility Criteria
Inclusion
- Age 15 years and older
- Head CT with presence of intracranial bleeding
- Required transfusion of whole blood (WB) or red blood cells (RBC)
Exclusion
- 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
Key Trial Info
Start Date :
August 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 30 2025
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT06184828
Start Date
August 1 2024
End Date
September 30 2025
Last Update
April 2 2024
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