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Quick blood test could spot brain injuries without CT scans

NCT ID NCT06834659

Diagnosis Sponsor: Università Vita-Salute San Raffaele 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 Results may not be published yet.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)
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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026 · Updated 1 time

Summary

This study will test a blood test called the Abbott i-STAT™ TBI Plasma Test in 200 adults who come to the emergency room with a traumatic brain injury. The test looks for two brain proteins (GFAP and UCH-L1) in the blood. Researchers will compare the blood test results to CT scans, which are the current gold standard, to see if the blood test can reliably rule out serious brain injuries, especially in mild cases. No extra procedures are needed beyond standard care.

What this could mean

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

Active substance
Abbott i-STAT™ TBI Plasma Test (blood test for GFAP and UCH-L1 biomarkers)
What this could lead to
If successful, this blood test could help emergency doctors quickly rule out serious brain injuries in mild TBI cases, reducing the need for CT scans and speeding up care.
What could go wrong
This is an observational study, not a treatment trial. The test may not be accurate enough to replace CT scans, and results might not apply to all patients or settings.

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 200 people

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

Expected to start

Jun 2027

An estimate. Start dates often move.

Expected to finish

Jun 2027

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

The study population is composed of adult patients aged between 18 and 65 years, conscious and unconscious, who present to the emergency department with traumatic brain injury (TBI) at triage. TBI is defined as trauma resulting from an external physical force capable of causing temporary or permanent alterations in consciousness and/or neurological function. The clinical severity of TBI (mild, moderate, or severe) will be assessed using the Glasgow Coma Scale (GCS), ensuring alignment with the study objectives.

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: * Patients aged 18 to 65, male and female, presenting to the emergency department due to TBI, defined as trauma caused by an external force leading to temporary or permanent alterations in consciousness and/or neurological function. TBI severity is evaluated using the Glasgow Coma Scale (GCS). * Sign of informed consent by patient or legal tutor Exclusion Criteria: * Pediatric patients (\<18 years). * Patients \>65 years, to avoid potential confounding factors such as elevated GFAP levels associated with Alzheimer's disease.

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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 (TBI) patients

How to take part

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

  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

  • IRCCS San Raffaele

    Milan, Italy, 20132, Italy

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