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NCT06062888 · ClinicalTrials.gov registry record · Phase 2

FFP In Traumatic BRAin INjury (FIT-BRAIN) Trial

A Phase 2 study of Moderate to Severe Traumatic Brain Injury, sponsored by Northwestern University.

Recruiting
Registry status
Phase 2
Development phase
357
Enrollment target
1
Study location

NCT06062888: Recruiting Phase 2 study of Moderate to Severe Traumatic Brain Injury, sponsored by Northwestern University.

NCT06062888 is a Phase 2 study of Moderate to Severe Traumatic Brain Injury that is actively recruiting participants, run by Northwestern University. The registered enrollment target is 357 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (168% higher). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT06062888, a Phase 2 study of Moderate to Severe Traumatic Brain Injury, is actively recruiting participants, sponsored by Northwestern University.

RECRUITING
Registry status
Phase 2
Development phase
357 participants
Enrollment target
1
Study location

Study 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.

Primary Outcome

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.

Interventions

  • BIOLOGICAL Fresh Frozen Plasma (FFP)

Study Locations (1)

Illinois

  • Northwestern University - Chicago

Trial Details

FieldValue
Enrollment Target 357 participants
Start Date 2026-02-01
Est. Completion 2029-06
Phase Phase 2
Northwestern University

1,209 total trials

What NCT06062888 shows while recruiting

NCT06062888 is an interventional study that assigns participants to a tested intervention. The registered 357 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (168% higher).

The record links to 1 condition, with Moderate to Severe Traumatic Brain Injury appearing as the primary indexed condition, and to 1 intervention - of which Fresh Frozen Plasma (FFP) is the first listed.

NCT06062888 reports a single indexed study location in Illinois.

Frequently Asked Questions

What is clinical trial NCT06062888 about?

NCT06062888 is a clinical study titled "FFP In Traumatic BRAin INjury (FIT-BRAIN) 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 ou...

What is the current status of trial NCT06062888?

This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 357 participants. The study started on 2026-02-01. Estimated completion is 2029-06.

What conditions does trial NCT06062888 study?

This clinical trial studies the following conditions: Moderate to Severe Traumatic Brain Injury.

What interventions are being tested in trial NCT06062888?

The interventions under investigation include: Fresh Frozen Plasma (FFP) (BIOLOGICAL).

Who is sponsoring clinical trial NCT06062888?

This trial is sponsored by Northwestern University, which has 1,209 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT06062888 being conducted?

This trial has 1 study location across Illinois. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

How this trial's enrollment target compares

Where NCT06062888's enrollment target sits among peer trials

357 127th of 2000 higher than 1,874 of 2,000 other Phase 2 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT06062888, the US trial registry maintained by the National Library of Medicine. NCT06062888 (mid enrollment · single site footprint · recruiting) retrieved and formatted by PlainTrial, see methodology.