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Blood test may replace unnecessary CT scans for mild brain injuries

NCT ID NCT07373509

Knowledge-focused Sponsor: Shawn Eagle Source: ClinicalTrials.gov ↗

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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 Results may not be published yet.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)
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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
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First seen Jun 27, 2026 · Last updated Jul 07, 2026 · Updated 2 times

Summary

This study looks at whether a new blood test can help emergency room doctors better assess patients with mild traumatic brain injury (TBI). The test checks for brain injury markers in the blood and may reduce the need for CT scans. Researchers will study how well the test works in 340 adults with mild head injuries and identify any barriers to using it in everyday practice.

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.

Participants

About 340 people

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

Started

Jan 2026

Expected to finish

Apr 2030

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.

Who is studied

Emergency department providers and patients with suspected TBI

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 Criteria: 1. Aged 18 or older 2. Presenting to an enrolling ED with ED Arrival GCS of 13-15 following reported head blunt impact within 24 hours of injury 3. Meets Department of Defense (DoD) definition of mTBI: A traumatically induced physiological disruption of brain function as a result of an external force that is indicated by new onset or worsening of at least one of the following clinical signs immediately following the event: 1. Any alteration of mental status (e.g., feeling dazed, disoriented, or confused) 2. Any period of loss of or a decreased level of consciousness, observed or self-report (loss of consciousness 30 minutes or less, an alteration of consciousness up to 24 hours) 3. Any loss of memory for events immediately before or after the injury (post-traumatic amnesia up to 1-day post-injury) Exclusion Criteria: 1. Treating emergency department provider does not think a head CT scan is needed 2. Inability to obtain results for iSTAT Alinity TBI test within 24 hours of injury 3. Treating emergency department attending physician is not willing to participate 4. Pre-existing neurologic condition 5. Contraindication or inability to complete blood draw 6. Significant polytrauma that, in the opinion of the principal investigators, could impact peripheral GFAP levels or require a full body scan 7. History of penetrating TBI 8. History of neurosurgical intervention for previous TBI 9. Penetrating TBI for current injury 10. Any history of brain surgery 11. Any history of brain tumor 12. Patients on psychiatric hold

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Conditions

The condition(s) this trial relates to.

Brain Concussion Brain Injuries, Traumatic traumatic brain injury

As listed by the trial registrant

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

Implementation research TBI (traumatic brain injury)

How to take part

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  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

  • University of Pittsburgh

    RECRUITING

    Pittsburgh, Pennsylvania, 15213, United States

More trials for these conditions

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