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Blood test may cut unnecessary CT scans for head injuries

NCT ID NCT07311486

Diagnosis Sponsor: Hospital Universitario 12 de Octubre 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 Results may not be published yet.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)
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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This study looks at whether a blood test measuring two brain injury markers can safely rule out the need for a CT scan in people with mild traumatic brain injury. Researchers will compare a new management pathway using this test to standard care in 1,000 emergency room patients. The goal is to reduce unnecessary CT scans and shorten time spent in the ER.

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 1,000 people

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

Started

Jul 2025

Expected to finish

May 2026

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

Mild traumatic brain injured patients admitted in the ER less than 12 hours after injury

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: * -All adult patients suffering mild TBI:( Defined by at least criterion a) and d) and one or more of the other criteria) 1. The presence of a plausible traumatic mechanism observed/or related by the patient´s recount of the injury event. 2. Presence of one or more clinical signs attributable to brain injury: Loss of consciousness immediately following injury, alteration of mental status immediately following the injury, posttraumatic amnesia or any neurological abnormality. 3. At least two acute symptoms related to the injury: feeling confused or disoriented, headache, nausea, vomiting, dizziness, vision problems, memory problems, emotional lability or irritability. 4. a GCS between 15 and 13, at least 30 minutes after injury. * Blood sample obtained ≤12 h after injury and ideally before any imaging prescription. Exclusion Criteria: * · GCS 3-12 on admission * Age Below 18 years * Time of injury unknown * Time to injury exceeding 12 hours * Primary admission for non-traumatic neurological disorder (e.g., stroke, spontaneous, intracranial hematoma) * Penetrating head trauma * Patient with mechanical ventilation from the trauma scene or prehospital management * Venipuncture not feasible

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Conditions

The condition(s) this trial relates to.

Brain Concussion traumatic brain injury

As listed by the trial registrant

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

Mild traumatic brain injury (MTBI)

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

  • Hospital Universitario 12 de Octubre

    RECRUITING

    Madrid, Madrid, 28041, Spain

More trials for these conditions

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