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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Traumatic Brain Injury
• Intervention / Treatment: Biological: Whole blood transfusion; Biological: Blood components transfusion

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.

• Study Type: Interventional
• Enrollment (Estimated): 100
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Laura H Nguyen; Phone Number: 503-418-4733; Email: nguyelau@ohsu.edu
• Study Contact Backup: Name: Samantha Underwood; Phone Number: 503-494-8481; Email: underwos@ohsu.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Whole Blood Transfusion; Transfusion of whole blood units	Biological: Whole blood transfusion; The transfusion of whole blood units
Active Comparator: Blood Component Transfusion; Transfusion of blood components units	Biological: Blood components transfusion; The transfusion of blood components units rather than whole blood

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Oregon Health and Science University

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Estimated): August 1, 2024
• Primary Completion (Estimated): September 30, 2025
• Study Completion (Estimated): September 30, 2025

Study Registration Dates

• First Submitted: December 7, 2023
• First Submitted That Met QC Criteria: December 14, 2023
• First Posted (Actual): December 28, 2023

Study Record Updates

• Last Update Posted (Actual): April 2, 2024
• Last Update Submitted That Met QC Criteria: April 1, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Brain Injuries; Wounds and Injuries; Brain Injuries, Traumatic
• Other Study ID Numbers: 25989

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No