Blood and brain scans may expose invisible injury after head trauma

NCT ID NCT04602806

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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 This study
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 Results may not be published yet.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

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Status unknown
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First seen Sep 02, 2026 · Last updated Sep 03, 2026 · Updated 1 time

Summary

Researchers are testing whether certain proteins in the blood and advanced brain scans can detect hidden damage in people with moderate to severe traumatic brain injury. The study enrolls 50 adults and follows them for 3 months, taking blood samples and MRI scans shortly after injury. The goal is to see if these markers can predict how well the brain recovers and guide future treatments.

What this could mean

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

Active substance
Blood biomarker tests and advanced MRI scans
What this could lead to
If these markers prove reliable, doctors could use a simple blood test or scan to detect hidden brain damage early and predict recovery after a traumatic brain injury.
What could go wrong
This is a small, early study with only 50 participants, so the markers may not prove accurate enough for wider use. The results depend on complex imaging and timing, which may limit how well they apply to all patients.

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

50 people

The number who actually took part.

Started

Jun 2021

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

This is a population-based TBI study. All patients presenting with traumatic brain injury and receive a head CT scan as part of standard care within 6 hours of injury are initially eligible.

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: * Age 18 - 65y inclusive * History or evidence of TBI, according to DoD-VA criteria * Glasgow Coma Scale (GCS) 3 - 15 after resuscitation in the ED * Head CT with evidence of trauma-related abnormality (except for isolated epidural hematoma (EDH)) * Ability to undergo MRI within 48 hours of injury * Ability to obtain informed consent from participant or Legally Authorized Representative (LAR) within 6 hours of injury * Fluency in English or Spanish Exclusion Criteria: * Unstable respiratory or hemodynamic status * Evidence of penetrating brain injury * Isolated EDH as only trauma-related CT abnormality * Systemic traumatic injury that would preclude participation in study, which is expected to result in long-term disability not related to TBI * Evidence of serious infectious complications (sepsis, bacteremia, multilobar pneumonia) * Acute ischemic heart disease (myocardial infarction or unstable angina) * History of syncope or hypotension * Systolic blood pressure (SBP) \< 90 mm Hg, Diastolic blood pressure (DBP)\< 40 mm Hg for longer than 5 minutes * History or evidence of active malignancy * History of pre-existing neurologic disorder, such as dementia, mild cognitive impairment, uncontrolled epilepsy, multiple sclerosis, strokes, brain tumors, prior severe TBI, or other disorder that may confound interpretation of MRI or neuropsychological results * History of pre-existing disabling mental illness, such as major depression or schizophrenia * History or evidence of chronic heart failure or chronic renal failure * Low likelihood of follow-up (e.g., participant or family indicating low interest, residence in another state or country, unhoused or lack of reliable contacts) * Women who are pregnant or breast-feeding * Prisoners or patients in custody * Patients on psychiatric hold (e.g. 5150, 5250)

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Conditions

The condition(s) this trial relates to.

Brain Concussion Brain Injuries, Traumatic Psychological Well-Being traumatic brain injury

As listed by the trial registrant

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

Contacts and locations

Locations

  • Medical College of Wisconsin

    Milwaukee, Wisconsin, 53226, United States

  • University of California, San Francisco

    San Francisco, California, 94110, United States

  • University of Pennsylvania/Penn Presbyterian Medical Center

    Philadelphia, Pennsylvania, 19104, United States

  • University of Pittsburgh Medical Center

    Pittsburgh, Pennsylvania, 15213, United States

  • University of Utah

    Salt Lake City, Utah, 84132, United States

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