Moderate to Severe Traumatic Brain InjuryPhase 2/3NCT06062888
FFP In Traumatic BRAin INjury (FIT-BRAIN) Trial
A Phase 2/3 study testing Fresh Frozen Plasma (FFP) in people with Moderate to Severe Traumatic Brain Injury, run by Northwestern University at 1 site in United States.
Trial summary
The goal of this clinical trial is to learn about treatment with fresh frozen plasma (FFP) in individuals with moderate to severe traumatic brain injury. The two main question[s]it aims to answer are: Is the FFP treatment safe? Does the FFP treatment impact the 24-hour, 3-month and 6-month outcomes, intensive-care… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Moderate to Severe Traumatic Brain Injury
- What is being tested?
- Fresh Frozen Plasma (FFP)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 357 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Feb 2026to Jun 2029
- Phase
- Phase 2/3
- Are there results?
- Not yet: the study is under way
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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female between the ages of 18 and 65 years
- Moderate to severe TBI: GCS 3-12
- Cerebral trauma confirmed on the initial CT scan with radiographic findings consistent with Brain Injury Guidelines category 3 (BIG 3).
- The potential participant's wallet, when present, was examined and no power of attorney related to blood product administration was identified.
Who cannot join
- Persons with a known history of adverse reaction to plasma products.
- Persons with a known history of congestive heart failure, renal failure, liver failure, or severe respiratory dysfunction requiring home use of supplemental oxygen.
- Persons who are currently incarcerated.
- Persons with inadequate venous access.
- Treatment cannot start within 1 hour of arrival at the hospital.
- The time of injury is unknown.
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- Non-survivable injuries in the estimation of the attending trauma and/or neurosurgeon.
- Interfacility transfers
- Class 3 hemorrhagic shock
- Persons with known "do not resuscitate" orders prior to randomization
- Persons who refuse the administration of blood products
- Persons with a research "opt out" bracelet
- Persons who require FFP for any other indication (e.g., reversal of coagulopathy)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Northwestern University
Chicago, Illinois, 60611
Nicole Meredyth, MD, 312-694-4867, nicole.meredyth@nm.org
About this study
Official title: Multi-institutional Phase 2/3 Trial of Fresh Frozen Plasma (FFP) in Patients With Moderate to Severe Traumatic Brain Injury (TBI)
The goal of this clinical trial is to learn about treatment with fresh frozen plasma (FFP) in individuals with moderate to severe traumatic brain injury. The two main question[s]it aims to answer are:
- Is the FFP treatment safe?
- Does the FFP treatment impact the 24-hour, 3-month and 6-month outcomes, intensive-care free days, mortality, and hospital brain and physical function at discharge. Patients with moderate to severe TBI will randomly receive either:
- Standard of care treatment
- Standard of care treatment + 2 units of FFP. Researchers will compare participants receiving standard of care treatment to those receiving experimental fresh frozen plasma (FFP) treatment to see if the FFP is safe and beneficial to participant outcomes.
Read the detailed description
The two units of fresh frozen plasma will consist of 400-500 ml. The 24-hour, 3-month and 6-month outcome measures include hemorrhagic progression of contusion (HPC) measured on 24-hour follow-up CT scan, the Disability Rating Score (DRS), 24-hour Glasgow Coma Scale (GCS) and the 3-month and 6-month Extended Glasgow Outcome Score (GOS-E).
A third sub aim of the trial is to establish peripheral blood biomarkers, and radiographic features on the initial cross- sectional imaging, that could identify the optimal target population and predict the response to treatment.
- Being tested
- Fresh Frozen Plasma (FFP)
- Keywords
- TBI, Traumatic Brain Injury, Fresh frozen plasma, FFP
- 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.
Fresh Frozen Plasma (FFP)Biological
Standard of Care + 2 units (400-500 ml) of fresh frozen plasma
| Study group | Role | What they receive |
|---|---|---|
| Standard of Care | No intervention | Standard of Care Control Group |
| Standard of Care + FFP | Experimental | Standard of Care + Experimental Treatment Receives: Biological: Fresh Frozen Plasma (FFP) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Extended Glasgow Outcome Scale (GOS-E)
Scoring values range from 1 to 8 with higher scores representing a better outcome. 1 indicates death, 2 indicates a vegetative state, 3 or 4 indicates severe disability, 5 or 6 indicates moderate disability, and 7 or 8 indicates good recovery.
Measured: 3 months
Secondary outcomes (2)
Hemorrhagic progression of the contusion (HPC)
We will quantify HPC as the change in volume of the largest contiguous brain lesion in mm. This will be measured through a comparison of the initial and the follow-up CT scan.
Measured: The first 24 hour post-injury
Disability Rating Scale (DRS)
This scale includes eight categories: A. Eye opening (0-5), B. Communication ability (0-4), C. Motor response (0-5), D. Feeding - cognitive ability only (0-3), E. Toileting - cognitive ability only (0-3), F. Grooming - cognitive ability only (0-3), G. Level of functioning - physical, mental, emotional or social function (0-5) and H. "Employability" - a full time worker, homemaker, or student (0-3). Higher scores in each category mean a worse outcome.
Measured: Discharge or day 7 of the hospital stay and 3 months post-injury
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2023
- Study start1 Feb 2026
- Primary completionAug 2028 (estimated)
- Study completionJun 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Moderate to Severe Traumatic Brain InjuryStudies of the same condition, open and under way.
- More trials run by Northwestern 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Control vs Experimental Biologic Group
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 357 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Northwestern University
- Sponsor type
- University, hospital or other
- Collaborators
- Vanderbilt University Medical Center, University of Southern California, Oregon Health and Science University, Medical College of Wisconsin, University of Texas Southwestern Medical Center, University of California, Davis, University of Alabama at Birmingham
- Responsible party
- Principal investigator, Hasan Alam, Northwestern University
- Investigators
- Hasan Alam, MD, Principal investigator, Northwestern University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06062888
- Sponsor's protocol ID
- PR212312
- Other IDs
- CDMRP-W81XWH2211106
- Status last verified
- Feb 2026
- First submitted
- 13 Sep 2023
- Last updated
- 11 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Liggett MR, Lashley S, Gill NP, Scholtens DM, Dawood ZS, Alam HB. Plasma therapy for traumatic brain injury: Rationale for a prospective randomized trial. Transfusion. 2024 Jul;64(7):1362-1371. doi: 10.1111/trf.17928. Epub 2024 Jun 28. No abstract available.
PubMed 38940059Joseph B, Obaid O, Dultz L, Black G, Campbell M, Berndtson AE, Costantini T, Kerwin A, Skarupa D, Burruss S, Delgado L, Gomez M, Mederos DR, Winfield R, Cullinane D; AAST BIG Multi-institutional Study Group. Validating the Brain Injury Guidelines: Results of an American Association for the Surgery of Trauma prospective multi-institutional trial. J Trauma Acute Care Surg. 2022 Aug 1;93(2):157-165. doi: 10.1097/TA.0000000000003554. Epub 2022 Mar 28.
PubMed 35343931Jin G, Liggett MR, Ho JW, Dawood ZS, Chtraklin K, Diaz D, Alam HB. Plasma treatment is associated with decreased brain lesion and resuscitation requirements after traumatic brain injury in a swine model of prolonged damage-control resuscitation. J Trauma Acute Care Surg. 2024 Dec 1;97(6):954-960. doi: 10.1097/TA.0000000000004457. Epub 2024 Oct 15.
PubMed 39733294
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multi-institutional Phase 2/3 Trial of Fresh Frozen Plasma (FFP) in Patients With Moderate to Severe Traumatic Brain Injury (TBI)
- ClinicalTrials.gov ID
- NCT06062888
- Acronym / sponsor ID
- PR212312
- Keywords
- TBI, Traumatic Brain Injury, Fresh frozen plasma, FFP
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 357 participants (estimated)
- Lead sponsor
- Northwestern UniversityUniversity, hospital or other
- Collaborators
- Vanderbilt University Medical Center, University of Southern California, Oregon Health and Science University, Medical College of Wisconsin, University of Texas Southwestern Medical Center, University of California, Davis, University of Alabama at Birmingham
- Study start
- 1 Feb 2026 (actual)
- Primary completion
- Aug 2028 (estimated)
- Study completion
- Jun 2029 (estimated)
- First posted
- 2 Oct 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.
The goal of this clinical trial is to learn about treatment with fresh frozen plasma (FFP) in individuals with moderate to severe traumatic brain injury. The two main question[s]it aims to answer are:
- Is the FFP treatment safe?
- Does the FFP treatment impact the 24-hour, 3-month and 6-month outcomes, intensive-care free days, mortality, and hospital brain and physical function at discharge. Patients with moderate to severe TBI will randomly receive either:
- Standard of care treatment
- Standard of care treatment + 2 units of FFP. Researchers will compare participants receiving standard of care treatment to those receiving experimental fresh frozen plasma (FFP) treatment to see if the FFP is safe and beneficial to participant outcomes.
Detailed description
The two units of fresh frozen plasma will consist of 400-500 ml. The 24-hour, 3-month and 6-month outcome measures include hemorrhagic progression of contusion (HPC) measured on 24-hour follow-up CT scan, the Disability Rating Score (DRS), 24-hour Glasgow Coma Scale (GCS) and the 3-month and 6-month Extended Glasgow Outcome Score (GOS-E).
A third sub aim of the trial is to establish peripheral blood biomarkers, and radiographic features on the initial cross- sectional imaging, that could identify the optimal target population and predict the response to treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Control vs Experimental Biologic Group
| Arm | Type | Receives |
|---|---|---|
| Standard of Care | No intervention | –Standard of Care Control Group |
| Standard of Care + FFP | Experimental | Biological: Fresh Frozen Plasma (FFP)Standard of Care + Experimental Treatment |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Male or female between the ages of 18 and 65 years
- Moderate to severe TBI: GCS 3-12
- Cerebral trauma confirmed on the initial CT scan with radiographic findings consistent with Brain Injury Guidelines category 3 (BIG 3).
- The potential participant's wallet, when present, was examined and no power of attorney related to blood product administration was identified.
Key exclusion criteria (13 listed)
- Persons with a known history of adverse reaction to plasma products.
- Persons with a known history of congestive heart failure, renal failure, liver failure, or severe respiratory dysfunction requiring home use of supplemental oxygen.
- Persons who are currently incarcerated.
- Persons with inadequate venous access.
- Treatment cannot start within 1 hour of arrival at the hospital.
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 |
|---|---|---|
| Fresh Frozen Plasma (FFP)Standard of Care + 2 units (400-500 ml) of fresh frozen plasma | Biological | Standard of Care + FFP |
Primary outcome
Extended Glasgow Outcome Scale (GOS-E)
Time frame: 3 months
Scoring values range from 1 to 8 with higher scores representing a better outcome. 1 indicates death, 2 indicates a vegetative state, 3 or 4 indicates severe disability, 5 or 6 indicates moderate disability, and 7 or 8 indicates good recovery.
2 secondary outcomes
Hemorrhagic progression of the contusion (HPC)
Time frame: The first 24 hour post-injury
Disability Rating Scale (DRS)
Time frame: Discharge or day 7 of the hospital stay and 3 months post-injury
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Feb 2026.
- Background: PubMed 38940059Liggett MR, Lashley S, Gill NP, Scholtens DM, Dawood ZS, Alam HB. Plasma therapy for traumatic brain injury: Rationale for a prospective randomized trial. Transfusion. 2024 Jul;64(7):1362-1371. doi: 10.1111/trf.17928. Epub 2024 Jun 28. No abstract available.
- Background: PubMed 35343931Joseph B, Obaid O, Dultz L, Black G, Campbell M, Berndtson AE, Costantini T, Kerwin A, Skarupa D, Burruss S, Delgado L, Gomez M, Mederos DR, Winfield R, Cullinane D; AAST BIG Multi-institutional Study Group. Validating the Brain Injury Guidelines: Results of an American Association for the Surgery of Trauma prospective multi-institutional trial. J Trauma Acute Care Surg. 2022 Aug 1;93(2):157-165. doi: 10.1097/TA.0000000000003554. Epub 2022 Mar 28.
- Derived from this study: PubMed 39733294Jin G, Liggett MR, Ho JW, Dawood ZS, Chtraklin K, Diaz D, Alam HB. Plasma treatment is associated with decreased brain lesion and resuscitation requirements after traumatic brain injury in a swine model of prolonged damage-control resuscitation. J Trauma Acute Care Surg. 2024 Dec 1;97(6):954-960. doi: 10.1097/TA.0000000000004457. Epub 2024 Oct 15.
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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.
Hasan Alam, MD principal investigator
Northwestern University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Fresh Frozen Plasma (FFP) in people with Moderate to Severe Traumatic Brain Injury, run by Northwestern University at 1 site in United States.
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 4 inclusion and 13 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: looking for participants now, as of the sponsor's last update on 11 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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 combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Hasan Alam, MD (312-926-4962, Hasan.Alam@nm.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Extended Glasgow Outcome Scale (GOS-E) (time frame: 3 months). 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 NCT06062888, which also lists 3 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 11 Feb 2026.