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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 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. The trial reports 1 study location across 1 state.

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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.

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

Sponsor

Northwestern University

1,209 total trials

What the Registry Record Tells You About NCT06062888

The ClinicalTrials.gov registry entry for NCT06062888 describes a study currently listed as recruiting, categorized as Phase 2. The registered enrollment target is 357 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Northwestern University, which has 1,209 total studies on file at ClinicalTrials.gov.

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 1 study location spanning 1 distinct geographic area - top geographies include 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.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.