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Blood test may spare thousands from unnecessary brain scans

NCT ID NCT06449183

Diagnosis Sponsor: BioMérieux Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 24, 2026 · Last updated Jun 27, 2026 · Updated 2 times

Summary

This study tested a blood test called VIDAS TBI on 903 adults with mild head injuries in the emergency room. The test measures two brain proteins to see if it can reliably rule out brain damage. If it works well, it could help doctors decide who truly needs a CT scan, saving time and reducing radiation exposure.

What this could mean

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

Active substance
VIDAS® TBI blood test (measures GFAP and UCH-L1 proteins)
What this could lead to
If successful, this blood test could help doctors quickly rule out serious brain injury in mild head trauma cases, reducing the need for CT scans and radiation exposure.
What could go wrong
This is a completed study analyzing real-world performance, but the test may not be accurate enough in all settings or populations, and it is not a treatment—it only aids diagnosis.

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

903 people

The number who actually took part.

Started

May 2024

Finished

Nov 2025

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

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 Criteria: * Adult subject ≥ 18 years old * Subject with a Glasgow Coma Scale (GCS) score between 13-15 on admission * Subject presenting to the Emergency Department for suspected mild Traumatic Brain Injury * Subject with a non-contrast head Computed Tomography (CT) scan ordered per the clinical site's care usual care * Blood sampling possible within 12 hours of injury (1 tube of 4-5 mL of blood) * Subject expected to stay at least 2 hours in the ED or in a ward * Subject with signed Informed Consent Form (ICF) Exclusion Criteria: * Time of injury unknown * Subject with non-traumatic neurological disorders (e.g, dementia, Parkinson's disease, multiple sclerosis, seizure disorder, brain tumors, spontaneous intracranial haematoma) * Neurosurgery, stroke or transient ischemic attack within the last 30 days * Subject with an active cancer * Subject with penetrating head injury * Special populations, including women with known pregnancy, prisoners, or institutionalized individuals

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Conditions

The condition(s) this trial relates to.

Brain Concussion Emergencies traumatic brain injury

As listed by the trial registrant

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

Mild traumatic brain injury

Contacts and locations

Locations

  • Mayo Clinic

    Rochester, Minnesota, 55905, United States

  • Orlando Health

    Orlando, Florida, 32806, United States

  • University of Rochester

    Rochester, New York, 14627, United States

  • Washington University

    St Louis, Missouri, 63130, United States

  • Wayne State University

    Detroit, Michigan, 48202, United States

More trials for these conditions

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