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Blood test may spare elderly from unnecessary brain scans after mild head injury

NCT ID NCT05425251

Diagnosis Sponsor: Hospital Universitario 12 de Octubre Source: ClinicalTrials.gov ↗

What the study statuses mean

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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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This study looked at whether measuring two proteins in the blood (GFAP and UCH-L1) can safely tell doctors when an older adult with a mild head injury does not need a CT scan. Over 2,200 participants aged 65 and older were enrolled. The goal is to reduce unnecessary radiation and costs while still catching serious brain injuries.

What this could mean

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

Active substance
Blood test measuring GFAP and UCH-L1 proteins
What this could lead to
If successful, this could reduce unnecessary CT scans and radiation exposure in elderly patients with mild head injury.
What could go wrong
This is a completed diagnostic study, not a treatment trial. The biomarkers may not be accurate enough in elderly patients with other health conditions.

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

2,297 people

The number who actually took part.

Started

Mar 2022

Finished

Mar 2025

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

2370 participants suffering mild TBI; 480 non TBI participants.

Ages

65 years and older

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

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: * BRAINI2-ELDERLY DIAGNOSTIC \& PROGNOSTIC: * Patients ≥65 years of age * Mild TBI (GCS 13-15 on admission) with indication of brain CT scan in the 12 hours after injury ; * Blood sample obtained ≤12 h after injury and CT scan preferably ≤6h from blood sample. * BRAINI2-ELDERLY REFERENCE: * Non TBI patients ≥65 years of age Exclusion Criteria: * BRAINI2-ELDERLY DIAGNOSTIC \& PROGNOSTIC: * Age below 65 years. * GCS 3-12 on admission * 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 * No realization of brain CT-scan * Subject under judiciary control * Subject in inclusion period of a drug interventional study * BRAINI2-ELDERLY REFERENCE: * Subject in inclusion period of another drug interventional study * Patients harboring a brain tumor * Patients that have had a stroke or neurosurgical operation 1 month prior to the inclusion in the study.

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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

Contacts and locations

Locations

  • CHU Clermont-Ferrand

    Clermont-Ferrand, France

  • CHU Grenoble-Alpes

    Grenoble, France

  • Hospital Universitari Vall d'Hebron

    Barcelona, Spain

  • Hospital Universitario 12 de Octubre

    Madrid, Madrid, 28041, Spain

  • Hôpital Edouard HERRIOT

    Lyon, France

  • Hôpital Lyon Sud HCL

    Lyon, France

  • Klinikum rechts der Isar

    Munich, Germany

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