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Blood test could spare Head-Injury patients a brain scan

NCT ID NCT07829107

Diagnosis Sponsor: University of Michigan Source: ClinicalTrials.gov ↗

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
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 Results may not be published yet.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)
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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
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Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Sep 18, 2026 · Last updated Sep 18, 2026

Summary

Researchers are testing whether adding a brain-injury blood test to standard clinical guidelines can safely reduce the number of brain CT scans ordered for adults who come to the emergency department with a suspected head injury. The blood test measures two proteins, GFAP and UCH-L1, that leak from injured brain cells. Six emergency departments will switch from using guidelines alone to the blood-test-plus-guidelines approach at staggered times over two years, and the study will track how often patients get CT scans and whether any serious brain injuries are missed.

What this could mean

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

Active substance
a brain-injury blood test measuring GFAP and UCH-L1 proteins, combined with the Canadian Head CT Rule
What this could lead to
If the blood-test approach works, emergency departments could safely skip many brain CT scans for head-injured patients, sparing them radiation exposure and long waits.
What could go wrong
The strategy could miss a serious brain bleed in some patients, and the study is still testing whether the algorithm performs well enough across different hospitals to be trusted.

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

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 3,000 people

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

Expected to start

Oct 2026

An estimate. Start dates often move.

Expected to finish

Jan 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 years and older

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 * Age ≥18 years at the time of the emergency department visit. * Presentation to a participating emergency department following a traumatic injury mechanism (motor vehicle collision, fall from height, assault, head injury/head trauma/head strike, struck by or against an object, facial injury or laceration, or other general trauma). Presentations may also include alcohol intoxication or syncope when associated with a suspected traumatic brain injury. * Evidence of potential head or brain injury, defined as (i) the head being struck by an object, (ii) the head striking a hard object or surface, (iii) exposure of the brain to significant acceleration/deceleration forces, or (iv) clinician documentation that the patient was evaluated for suspected traumatic brain injury. * Glasgow Coma Scale (GCS) score of 13-15 at presentation. * Presentation to the emergency department within 24 hours of injury. Exclusion Criteria: * Planned computed tomography (CT) imaging of the maxillofacial bones, chest, abdomen, or pelvis during the ED encounter AND clinicians do not intend to avoid brain CT imaging even if the biomarker test is negative. * Current use of anticoagulant or antiplatelet therapy, including but not limited to: Warfarin, Factor Xa inhibitors (e.g., apixaban \[Eliquis\], rivaroxaban \[Xarelto\]), Clopidogrel, Ticagrelor. * Presentation \>24 hours after injury, due to the declining diagnostic sensitivity of Glial Fibrillary Acidic Protein (GFAP) and Carboxy-terminal Hydrolase L1 (UCH-L1) beyond this time window.

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Conditions

The condition(s) this trial relates to.

Brain Concussion Brain Injuries, Traumatic Emergencies head injury traumatic brain injury

As listed by the trial registrant

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

Head injury trauma Traumatic brain injury, mild

How to take part

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

  1. The places running it

    6 sites. 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

  • Adventist Health Portland (AHP)

    Portland, Oregon, 97216, United States

  • Harbor-UCLA Medical Center

    Torrance, California, 90502, United States

  • Henry Ford Hospital (HFH)

    Detroit, Michigan, 48202, United States

  • Henry Ford Macomb (HFM)

    Clinton Township, Michigan, 48038, United States

  • Oregon Health & Science University (OHSU)

    Portland, Oregon, 97239, United States

  • UCLA-Olive View Medical Center

    Sylmar, California, 91342, United States

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