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RECRUITING Phase 2

FFP In Traumatic BRAin INjury (FIT-BRAIN) Trial

NCT06062888 · View on ClinicalTrials.gov ↗

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

1,033 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT06062888

The ClinicalTrials.gov registry entry for NCT06062888 describes a study currently listed as recruiting. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. 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 1,033 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT06062888 reports 1 study location spanning 1 distinct geographic area — top geographies include Illinois. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT06062888?

The interventions under investigation include: Fresh Frozen Plasma (FFP) (BIOLOGICAL). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT06062888?

This trial is sponsored by Northwestern University, which has 1,033 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

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