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

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Northwestern University
  Chicago, Illinois, United States Recruiting

Study contacts

• Principal investigator: Hasan Alam, MD — Northwestern University
• Study coordinator: Hasan Alam, MD
• Email: Hasan.Alam@nm.org
• Phone: 312-926-4962

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Understanding brain function and cognitive outcomes after traumatic brain injury

  This study is trying to see how blood flow and brain health after a serious head injury affect thinking and memory recovery one year later for those who have had a moderate to severe traumatic brain injury.

  Recruiting at 3 sites University of Texas Southwestern Medical Center · Dallas, Texas and 2 other locations · NCT06480838

• Comparing two group wellness programs for people with brain injuries and their caregivers

  This study is testing two different online wellness programs to see if they can help people with brain injuries and Alzheimer's disease, along with their caregivers, feel better and improve their quality of life.

  Recruiting Kessler Foundation · East Hanover, New Jersey · NCT05048966

• Using Biperiden to Prevent Epilepsy After Brain Injury

  This study tests if the medication biperiden can help prevent seizures in adults who have had a serious brain injury.

  Recruiting at 6 sites Phase 3 Hospital Sirio-Libanes · Fortaleza, Ceará and 9 other locations · NCT04945213

• Online memory intervention for people with traumatic brain injury

  This study tests whether an online memory training program can help people with moderate to severe traumatic brain injury improve their memory and brain health.

  Recruiting Toronto Rehabilitation Institute · Toronto, Ontario · NCT04331392

• Understanding cerebral vasospasm in traumatic brain injury with subarachnoid hemorrhage

  This study is testing how common and serious blood vessel narrowing in the brain is for adults with moderate to severe traumatic brain injuries and bleeding, to see if better scans can help improve their care.

  Recruiting University Hospital Center of Martinique · Fort-de-France · NCT06560372

• Monitoring intracranial pressure in patients with moderate traumatic brain injury

  This study is testing if keeping track of pressure inside the skull can help people with moderate traumatic brain injury in China recover better compared to those who don't have this monitoring.

  Recruiting Tang-Du Hospital · Xi'an, Shannxi Province · NCT04900168

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.