Fresh frozen plasma for moderate-to-severe traumatic brain injury (FIT-BRAIN)

Multi-institutional Phase 2/3 Trial of Fresh Frozen Plasma (FFP) in Patients With Moderate to Severe Traumatic Brain Injury (TBI)

This trial will try adding two units of fresh frozen plasma to standard care in adults 18–65 with moderate to severe TBI to see if it is safe and improves short- and longer-term brain and functional outcomes.

Quick facts

• Phase: Phase2; Phase3
• Study type: Interventional
• Enrollment: 357 (estimated)
• Ages: 18 Years to 65 Years
• Sex: All
• Sponsor: Northwestern University (Academic / other)
• Locations: 1 site (Chicago, Illinois)
• Trial ID: NCT06062888 on ClinicalTrials.gov

What this trial studies

This randomized phase 2/3 study assigns adults with moderate-to-severe traumatic brain injury to standard care alone or standard care plus two units (400–500 mL) of fresh frozen plasma (FFP). Treatment must start quickly after hospital arrival and researchers will measure hemorrhagic progression on 24-hour CT, 24-hour Glasgow Coma Scale, Disability Rating Scale, and Extended Glasgow Outcome Scale at 3 and 6 months, along with ICU-free days and mortality. A nested sub-study will collect blood biomarkers and baseline imaging features to identify who is most likely to benefit. The trial is led by a major academic trauma center network with enrollment at participating sites.

Who should consider this trial

Good fit: Adults aged 18–65 with moderate to severe TBI (GCS 3–12) and CT findings consistent with BIG 3 who can receive treatment within one hour of hospital arrival are the intended participants.

Not a fit: People with known plasma reactions, advanced organ failure, severe respiratory disease on home oxygen, class 3 hemorrhagic shock, unknown time of injury, interfacility transfers, current incarceration, inadequate venous access, or judged to have non-survivable injuries are excluded and unlikely to benefit from this protocol.

Why it matters

Potential benefit: If successful, adding FFP could reduce bleeding progression and improve survival and functional recovery after moderate-to-severe TBI.

How similar studies have performed: While plasma-based resuscitation has evidence in hemorrhagic trauma, randomized data specific to adding FFP for isolated moderate-to-severe TBI are limited, so this application is relatively novel.

Eligibility criteria

Inclusion Criteria:

1. Male or female between the ages of 18 and 65 years
2. Moderate to severe TBI: GCS 3-12
3. Cerebral trauma confirmed on the initial CT scan with radiographic findings consistent with Brain Injury Guidelines category 3 (BIG 3).
4. The potential participant's wallet, when present, was examined and no power of attorney related to blood product administration was identified.

Exclusion Criteria:

1. Persons with a known history of adverse reaction to plasma products.
2. Persons with a known history of congestive heart failure, renal failure, liver failure, or severe respiratory dysfunction requiring home use of supplemental oxygen.
3. Persons who are currently incarcerated.
4. Persons with inadequate venous access.
5. Treatment cannot start within 1 hour of arrival at the hospital.
6. The time of injury is unknown.
7. Non-survivable injuries in the estimation of the attending trauma and/or neurosurgeon.
8. Interfacility transfers
9. Class 3 hemorrhagic shock
10. Persons with known "do not resuscitate" orders prior to randomization
11. Persons who refuse the administration of blood products
12. Persons with a research "opt out" bracelet
13. Persons who require FFP for any other indication (e.g., reversal of coagulopathy)

Where this trial is running

Chicago, Illinois

• Northwestern University — Chicago, Illinois, United States (Recruiting)

Study contacts

• Principal investigator: Hasan Alam, MD — Northwestern University
• Study coordinator: Hasan Alam, MD

Conditions Moderate to Severe Traumatic Brain Injury; TBI; Traumatic Brain Injury; Fresh frozen plasma; FFP