Recruiting
Phase 2
Phase 3

FFP

Sponsor:

Northwestern University

Code:

NCT06062888

Conditions

Moderate to Severe Traumatic Brain Injury

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

Interventions

Fresh Frozen Plasma (FFP)

Study Details

Brief 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 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.

Conditions

Moderate to Severe Traumatic Brain Injury

Study ID

NCT06062888

Start date

Feb 1, 2026

Status verified date

Feb, 2026

Completion date

Jun, 2029

Anticipated

Primary completion date

Aug, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

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)

Study Design

Enrollment

357 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

no intervention: Standard of Care

Standard of Care Control Group

experimental: Standard of Care + FFP

Standard of Care + Experimental Treatment

Interventions

Fresh Frozen Plasma (FFP)

Standard of Care + 2 units (400-500 ml) of fresh frozen plasma

Primary outcome measure

  • Extended Glasgow Outcome Scale (GOS-E) [ Time Frame: 3 months ]

Central Contacts and Locations

Central contacts

Hasan Alam, MD

312-926-4962Hasan.Alam@nm.org

Nicole Meredyth, MD

312-694-4867nicole.meredyth@nm.org

Locations

Northwestern University

Recruiting

Chicago, Illinois, United States, 60611

Contacts

Nicole Meredyth, MD

312-694-4867nicole.meredyth@nm.org

More Information

Sponsor

Northwestern University

Last update posted

Feb 11, 2026

Last verified

Feb, 2026

Keywords

  • TBI
  • Traumatic Brain Injury
  • Fresh frozen plasma
  • FFP

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Northwestern University on 2026-02-11.