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

Traumatic Brain Injury Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06184828
• Other study ID #: 25989
• Status: Not yet recruiting
• Phase: Phase 3
• Start date: August 1, 2024
• Est. completion date: September 30, 2025

Study information

• Verified date: April 2024
• Source: Oregon Health and Science University
• Contact: Laura H Nguyen
• Phone: 503-418-4733
• Email: nguyelau[@]ohsu.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: September 30, 2025
• Est. primary completion date: September 30, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 15 Years to 120 Years

Eligibility

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

Related Conditions & MeSH terms

• Brain Injuries
• Brain Injuries, Traumatic
• Traumatic Brain Injury
• Wounds and Injuries

Intervention

Biological:
• Whole blood transfusion
The transfusion of whole blood units
• Blood components transfusion
The transfusion of blood components units rather than whole blood

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Oregon Health and Science University

References & Publications (4)

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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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