FFP In Traumatic BRAin INjury (FIT-BRAIN) Trial
Recruiting
Phase 2
Phase 3
Interventional Study
Moderate to Severe Traumatic Brain Injury
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Pivotal Trial
This treatment is in the last trial phase before FDA approval.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 18 – 65
- Sex
- Any
- Trial phase
- Phase 2/3
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 357 (estimated)
- Sponsor
- Northwestern University · Other
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About This Trial
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. …
Trial Locations
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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 presen…
Contacts