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Blood test may spare thousands of kids from unnecessary CT scans after head injury

NCT ID NCT05413499

Diagnosis Sponsor: Nantes University Hospital 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
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 Results may not be published yet.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)
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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 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 help doctors safely avoid CT scans in children with mild traumatic brain injury. Over 1,500 children across Europe participated. The goal was to see if these blood tests are accurate enough to detect serious brain injuries and predict recovery, potentially reducing radiation exposure from CT scans.

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.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

1,570 people

The number who actually took part.

Started

Aug 2022

Finished

May 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.

Ages

0 days to 18 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: Children and adolescents \<18 years old Consent from one of the parents of the child or from holder of parental responsibility Consent from the child or adolescent Parental affiliation with an appropriate health insurance system 1. TBI population * Admission within 24 hours of the injury * Ability to follow-up by telephone, mail or email * For the mTBI group: * GCS score of 13-15 on admission * Indication for cerebral CT scan according to national or local guidelines or the in-charge physician OR diagnosis of concussion consistent with the fourth Zurich consensus statement (9) . Concussion was defined as a complex pathophysiological process caused by a direct blow to the head, face, neck, or elsewhere on the body with an impulsive force transmitted to the head (which may or may not have involved loss of consciousness), resulting in a brain injury with one or more symptoms in one or more of the following clinical domains: somatic, cognitive, emotional or behavioural, or sleep. To objectively help diagnose concussion, the validated Acute Concussion Evaluation (ACE) questionnaire (10) for children with mTBI will be used, the presence of ≥ 1 symptom on the ACE defines concussion. * For the moderate or severe TBI group: * GCS score of 3-12 on admission * Indication for cerebral CT scan according to national or local guidelines or the in-charge physician 2. Non-TBI control paediatric population * Admission for any reason other than TBI * Indication of blood sampling for their routine management * GCS score of 15 * Otherwise healthy, i.e. without chronic pathology Exclusion Criteria: 1. TBI population * Time of injury unknown or exceeding 24 hours * Blood sampling not possible within 24 hours after the injury or 6 hours after the CT scan, if applicable * Penetrating brain injury with skull fracture * Pre-existing neurological disorders affecting the assessment of neurological outcome, seizure disorder/epilepsy, brain tumour, history of neurosurgery, stroke, encephalopathy * Venepuncture not feasible * Pregnant woman * Intoxication * No clear primary mechanism of trauma * No possibility for transferring CT scan images to the centralised platform in case of neuroimaging only performed in an outside hospital before transfer * Participation in another interventional research study 2. Non-TBI control paediatric population * Pre-existing neurological disorders, seizure disorder/epilepsy, brain tumour, history or indication of neurosurgery, stroke, encephalopathy * History of TBI * Orthopaedic trauma or surgery within the last month * Suspected meningitidis or encephalitis * Venepuncture not feasible * Pregnant woman * Intoxication * Participation in another interventional research 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

Contacts and locations

Locations

  • Armand Trousseau hospital (AP-HP)

    Paris, France

  • Brest University Hospital

    Brest, France

  • Clermont-Ferrand University Hospital

    Clermont-Ferrand, France

  • Grenoble University Hospital

    Grenoble, France

  • Hospital 12 de Octubre

    Madrid, Spain

  • Hospital Infantil Universitario Nino Jesus

    Madrid, Spain

  • Hospital Universitari Vall d'Hebron (ICS)

    Barcelona, Spain

  • Klinikum rechts der Isar, Technical University of Munich

    Munich, Germany

  • La Roche/Yon Hospital

    La Roche-sur-Yon, France

  • Lille University Hospital

    Lille, France

  • Limoges University Hospital

    Limoges, France

  • Lorient Hospital

    Lorient, France

  • Louis Mourier Hospital (AP-HP)

    Colombes, France

  • Luzerner Kantonsspital

    Lucerne, Switzerland

  • Montpellier University Hospital

    Montpellier, France

  • Nantes University Hospital

    Nantes, France

  • Rennes University Hospital

    Rennes, France

  • Robert Debré Hospital (AP-HP)

    Paris, France

  • Saint Etienne University Hospital

    Saint-Etienne, France

  • Saint Nazaire Hospital

    Saint-Nazaire, France

More trials for these conditions

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