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Simple blood test could revolutionize traumatic brain injury diagnosis

NCT ID NCT07455136

Diagnosis Sponsor: Hoffmann-La Roche 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Sep 21, 2026 · Updated 7 times

Summary

This study aims to create a blood test that helps doctors quickly diagnose traumatic brain injury (TBI) and predict how patients will recover. Researchers will collect blood samples from 2,000 adults with suspected TBI in emergency rooms and hospitals. The goal is to find specific markers in the blood that can confirm injury and monitor for complications, potentially reducing the need for CT scans and improving patient care.

What this could mean

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

What this could lead to
If successful, this could lead to a simple blood test that helps doctors quickly diagnose traumatic brain injury and predict recovery, reducing reliance on CT scans.
What could go wrong
This is an early-stage study focused on developing and validating the test, not yet proving it works in routine practice. The test may not be accurate enough to replace current methods.

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 2,000 people

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

Started

Feb 2026

Expected to finish

Nov 2028

An estimate. End dates often move.

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.

Who is studied

Participants who present at the emergency department with suspected TBI as per the eligibility criteria from approximately 10 to 15 sites in geographically diverse locations within the United States.

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: * Presenting to the Emergency Department with a biomechanically plausible mechanism of non-penetrating traumatic brain injury (TBI; direct impact: blow to the head, head against object, object against head; acceleration/deceleration) * Acute brain CT completed for standard of care Further Inclusion Criteria (specific for CLIN12.2): * Admitted to the hospital with radiographic evidence of acute TBI * Admitted to the intensive care unit at risk for decline related to TBI Exclusion Criteria: * Prior neurosurgical intervention within the last 6 months * Major debilitating neurological disease (such as, but not limited to: stroke, CVA, mild cognitive impairment, Alzheimer's disease, Amyotrophic lateral sclerosis, Parkinson's disease, Huntington's disease, Frontotemporal dementia, tumor, epilepsy, unmanaged seizure disorder), impairing baseline awareness, cognition, or validity of outcomes assessments * Major debilitating baseline mental health disorders (such as but not limited to schizophrenia or bipolar disorder) that would interfere with follow-up and the validity of outcome assessments * Significant pre-existing conditions that would interfere with follow-up and outcome assessment (such as, but not limited to: chronic kidney disease, chronic cardiovascular comorbidities, alcohol or substance use disorder) * History of melanoma * Primary diagnosis of ischemic or hemorrhagic stroke * Any spinal Cord Injury (American Spinal Injury Association \[ASIA\] score of A-D) * Received chemotherapy or radiation currently or within the last year * Patients on psychiatric hold (e.g., 5150, 5250) * Current incarceration or in custody * Known inability to undergo an MRI * Currently receiving any interventional treatments as a part of an investigational study/trial (drug, device, behavioral, treatment) at the time of enrollment and/or during the course of this study * Low likelihood of follow-up (e.g. participant or family indicating low interest, residence in another state or country, homelessness or lack of reliable contacts) * Any condition that, in the opinion of the investigator, could interfere in the proper execution of the study procedures and/or in their future permanence in the study

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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.

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

    13 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

  • Atrium Health - Carolina Medical Center

    RECRUITING

    Charlotte, North Carolina, 28203, United States

  • Baylor College of Medicine

    NOT_YET_RECRUITING

    Houston, Texas, 77030, United States

  • Brown University

    NOT_YET_RECRUITING

    Providence, Rhode Island, 29903, United States

  • Goodman Campbell Brain and Spine/Ascension

    NOT_YET_RECRUITING

    Carmel, Indiana, 46032, United States

  • Medical College of Wisconsin

    NOT_YET_RECRUITING

    Milwaukee, Wisconsin, 53226, United States

  • Northwell Health - Department Of Neurosurgery

    NOT_YET_RECRUITING

    Manhasset, New York, 11030, United States

  • University Of California Davis, Neurological Surgery

    RECRUITING

    Sacramento, California, 95817, United States

  • University of California San Francisco

    RECRUITING

    San Francisco, California, 94110, United States

  • University of Cincinnati

    RECRUITING

    Cincinnati, Ohio, 45229, United States

  • University of Pennsylvania Medical Center

    RECRUITING

    Philadelphia, Pennsylvania, 19104, United States

  • University of Pittsburgh Medical Center

    RECRUITING

    Pittsburgh, Pennsylvania, 15213, United States

  • University of Utah

    NOT_YET_RECRUITING

    Salt Lake City, Utah, 84132, United States

  • University of Wisconsin

    WITHDRAWN

    Madison, Wisconsin, 53792, United States

  • Vanderbilt University Medical Center

    NOT_YET_RECRUITING

    Nashville, Tennessee, 37203, United States

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