Traumatic Brain InjuryPhase 3NCT06184828
Pilot Study of Whole Blood Transfusion for Trauma Brain Injury (TBI)
A Phase 3 study testing Whole blood transfusion and Blood components transfusion in people with Traumatic Brain Injury, run by Oregon Health and Science University.
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. Read more about this study
- Who is it for?
- Ages 15 to 120 yearsHealthy volunteers can take part
- Conditions the study is for
- Traumatic Brain Injury
- What is being tested?
- Whole blood transfusion and Blood components transfusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 1 Aug 2024to 30 Sep 2025
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 to 120 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Age 15 years and older
- Head CT with presence of intracranial bleeding
- Required transfusion of whole blood (WB) or red blood cells (RBC)
Who cannot join
- 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
Trial locations and contacts
No sites are listed yet.
About this study
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.
Read the 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
- Being tested
- Whole blood transfusion, Blood components transfusion
- Medical subject headings
- Brain Injuries, Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Whole blood transfusionBiological
The transfusion of whole blood units
Blood components transfusionBiological
The transfusion of blood components units rather than whole blood
| Study group | Role | What they receive |
|---|---|---|
| Whole Blood Transfusion | Experimental | Transfusion of whole blood units Receives: Biological: Whole blood transfusion |
| Blood Component Transfusion | Active comparator | Transfusion of blood components units Receives: Biological: Blood components transfusion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mortality and Morbidity
The primary outcome for this study would be Glasgow Outcome Coma Scale score at discharge.
Measured: Up to 30 days after hospital admission
Secondary outcomes (1)
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).
Measured: Up to 30 days after hospital admission
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Dec 2023
- Study start1 Aug 2024 (estimated)
- Primary completion30 Sep 2025 (estimated)
- Study completion30 Sep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Traumatic Brain InjuryStudies of the same condition, open and under way.
- More trials run by Oregon Health and Science UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Pilot, single center, and a randomized 1:1 trial.
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Oregon Health and Science University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Martin A Schreiber, MD, Oregon Health and Science University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06184828
- Sponsor's protocol ID
- 25989
- Status last verified
- Apr 2024
- First submitted
- 7 Dec 2023
- Last updated
- 2 Apr 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 16763477Timmons 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.
PubMed 16960286Corwin 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.
PubMed 17442910Reiles 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.
PubMed 17583592
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study of Whole Blood Transfusion for Trauma Brain Injury (TBI)
- ClinicalTrials.gov ID
- NCT06184828
- Acronym / sponsor ID
- 25989
- Conditions
- Traumatic Brain Injury
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Oregon Health and Science UniversityUniversity, hospital or other
- Study start
- 1 Aug 2024 (estimated)
- Primary completion
- 30 Sep 2025 (estimated)
- Study completion
- 30 Sep 2025 (estimated)
- First posted
- 28 Dec 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Pilot, single center, and a randomized 1:1 trial.
| Arm | Type | Receives |
|---|---|---|
| Whole Blood Transfusion | Experimental | Biological: Whole blood transfusionTransfusion of whole blood units |
| Blood Component Transfusion | Active comparator | Biological: Blood components transfusionTransfusion of blood components units |
Who may qualify
- Ages
- 15 to 120 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Age 15 years and older
- Head CT with presence of intracranial bleeding
- Required transfusion of whole blood (WB) or red blood cells (RBC)
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Whole blood transfusionThe transfusion of whole blood units | Biological | Whole Blood Transfusion |
| Blood components transfusionThe transfusion of blood components units rather than whole blood | Biological | Blood Component Transfusion |
Primary outcome
Mortality and Morbidity
Time frame: Up to 30 days after hospital admission
The primary outcome for this study would be Glasgow Outcome Coma Scale score at discharge.
1 secondary outcome
Improvement in Coagulopathy
Time frame: Up to 30 days after hospital admission
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Apr 2024.
- Background: PubMed 16763477Napolitano 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.
- Background: PubMed 16960286Timmons 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.
- Background: PubMed 17442910Corwin 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.
- Background: PubMed 17583592Reiles 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Whole blood transfusion and Blood components transfusion in people with Traumatic Brain Injury, run by Oregon Health and Science University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 2 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Laura H Nguyen (503-418-4733, nguyelau@ohsu.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mortality and Morbidity (time frame: Up to 30 days after hospital admission). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06184828, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Apr 2024.