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

NCT ID: NCT06184828

Last Updated: 2024-04-02

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE3
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-08-01
• Study Completion Date: 2025-09-30

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.

Conditions

Traumatic Brain Injury

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Whole Blood Transfusion

Transfusion of whole blood units

Group Type: EXPERIMENTAL

Whole blood transfusion

Intervention Type: BIOLOGICAL

The transfusion of whole blood units

Blood Component Transfusion

Transfusion of blood components units

Group Type: ACTIVE_COMPARATOR

Blood components transfusion

Intervention Type: BIOLOGICAL

The transfusion of blood components units rather than whole blood

Interventions

Whole blood transfusion

The transfusion of whole blood units

Intervention Type: BIOLOGICAL

Blood components transfusion

The transfusion of blood components units rather than whole blood

Intervention Type: BIOLOGICAL

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

• Minimum Eligible Age: 15 Years
• Maximum Eligible Age: 120 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Oregon Health and Science University

OTHER

Sponsor Role: lead

Responsible Party

Martin A Schreiber, MD

M.D., F.A.C.S., F.C.C.M.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Central Contacts

Laura H Nguyen

Role: CONTACT

nguyelau@ohsu.edu

503-418-4733

Samantha Underwood

Role: CONTACT

underwos@ohsu.edu

503-494-8481

References

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.

Reference Type: BACKGROUND

PMID: 16763477 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 16960286 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 17442910 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 17583592 (View on PubMed)

Other Identifiers

25989

Identifier Type: -

Identifier Source: org_study_id