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Can plasma help heal the brain after injury?

NCT ID NCT06062888

Disease control Sponsor: Northwestern University Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study is testing whether giving fresh frozen plasma (FFP) to people with moderate to severe traumatic brain injury can improve their recovery. About 357 adults aged 18-65 will be randomly assigned to receive either standard care alone or standard care plus two units of FFP. Researchers will track safety and outcomes like disability, hospital stay, and brain function up to 6 months later.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Fresh frozen plasma (FFP)
What this could lead to
If it works, this could provide a new treatment to improve recovery and reduce disability after traumatic brain injury.
What could go wrong
This is a mid-stage trial, so results are not guaranteed. The treatment may not improve outcomes and carries risks like allergic reactions or infection from plasma.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2/3

Runs two stages together: whether the treatment works, then large-scale confirmation.

Participants

About 357 people

The number the study aims to enrol. It can still change while the study runs.

Started

Feb 2026

Expected to finish

Jun 2029

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 65 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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)

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Conditions

The condition(s) this trial relates to.

Brain Injuries, Traumatic traumatic brain injury

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Moderate-to-severe traumatic brain injury

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Northwestern University

    RECRUITING

    Chicago, Illinois, 60611, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.