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

NCT06184828 | Not Yet Recruiting Phase 3 DMC

• 1 other identifier: 25989
• Study Type: interventional
• Target: 100
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Traumatic Brain Injury

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Improvement in Coagulopathy

  Up to 30 days after hospital admission

Study Arms (2)

Whole Blood Transfusion

EXPERIMENTAL

Transfusion of whole blood units

Biological: Whole blood transfusion

Blood Component Transfusion

ACTIVE COMPARATOR

Transfusion of blood components units

Biological: Blood components transfusion

Interventions

Whole blood transfusion BIOLOGICAL

The transfusion of whole blood units

Whole Blood Transfusion

Blood components transfusion BIOLOGICAL

The transfusion of blood components units rather than whole blood

Blood Component Transfusion

Eligibility Criteria

• Age: 15 Years - 120 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 15 years and older
• Head CT with presence of intracranial bleeding
• Required transfusion of whole blood (WB) or red blood cells (RBC)

You may not qualify if:

• 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

Sponsors & Collaborators

• Oregon Health and Science University: lead

Related Publications (4)

• 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.

  PMID: 16763477 BACKGROUND

• 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.

  PMID: 16960286 BACKGROUND

• 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.

  PMID: 17442910 BACKGROUND

• 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.

  PMID: 17583592 BACKGROUND

MeSH Terms

Conditions

Brain Injuries, Traumatic

Interventions

Exchange Transfusion, Whole Blood

Condition Hierarchy (Ancestors)

Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Blood Transfusion; Biological Therapy; Therapeutics

Central Study Contacts

Laura H Nguyen

CONTACT

503-418-4733; nguyelau@ohsu.edu

Samantha Underwood

CONTACT

503-494-8481; underwos@ohsu.edu

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: M.D., F.A.C.S., F.C.C.M.

Model Details: Pilot, single center, and a randomized 1:1 trial.

Study Record Dates

• First Submitted: December 7, 2023
• First Posted: December 28, 2023
• Study Start: August 1, 2024
• Primary Completion: September 30, 2025
• Study Completion: September 30, 2025
• Last Updated: April 2, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share