Clinical trial NCT06184828: Pilot Study of Whole Blood Transfusion for Trauma Brain Injury (TBI)
Official title: Pilot Study of Whole Blood Transfusion for Trauma Brain Injury (TBI)
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE3
Conditions: Traumatic Brain Injury
Lead sponsor: Oregon Health and Science University
Sponsor class: OTHER
First posted: 2023-12-28
Enrollment: 100
Sex: ALL
Minimum age (years): 15
Maximum age (years): 120
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Pilot, single center, and a randomized 1:1 trial.
Primary purpose: TREATMENT

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 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.

Eligibility criteria: 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

Primary outcomes:
measure: Mortality and Morbidity
timeFrame: Up to 30 days after hospital admission
Secondary outcomes:
measure: Improvement in Coagulopathy
timeFrame: Up to 30 days after hospital admission
Other outcomes:
Locations:
Study officials:
References:
citation: Napolitano L. Cumulative risks of early red blood cell transfusion. J Trauma. 2006 Jun;60(6 Suppl):S26-34. doi: 10.1097/01.ta.0000199979.95789.17. No abstract available.
citation: Timmons SD. The life-saving properties of blood: mitigating cerebral insult after traumatic brain injury. Neurocrit Care. 2006;5(1):1-3. doi: 10.1385/NCC:5:1:1.
citation: Corwin HL, Carson JL. Blood transfusion--when is more really less? N Engl J Med. 2007 Apr 19;356(16):1667-9. doi: 10.1056/NEJMe078019. No abstract available.
citation: Reiles E, Van der Linden P. Transfusion trigger in critically ill patients: has the puzzle been completed? Crit Care. 2007;11(3):142. doi: 10.1186/cc5936.