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Blood test may spare kids from unneeded radiation after head bumps

NCT ID NCT02819778

What the study statuses mean

This study's is highlighted.

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 tested whether measuring a protein called S100B in the blood can help doctors decide if a child with a mild head injury needs a CT scan. Over 2,200 children were assigned to either standard care or care guided by the S100B test. The goal was to see if the test could safely cut down on CT scans, which expose children to radiation that may increase cancer risk.

What this could mean

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

Active substance
S100B blood test
What this could lead to
If successful, this blood test could become a standard tool to safely avoid many CT scans in children with mild head injuries, reducing radiation risks.
What could go wrong
The test may not be accurate enough to replace CT scans in all cases, and results might vary across different hospitals or patient groups.

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

2,209 people

The number who actually took part.

Started

Nov 2016

Finished

May 2022

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 to 16 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 ≤ 16 years Therapeutic management within 3 hours after TBI GCS score of 15 classically requiring hospitalization and/or CCT-scan as per SFP recommendations (Lorton et al., 2014). These criteria are: * For children aged under 2 years (CCT-scan or hospitalization recommended according to physician's evaluation): * Parietal or occipital scalp hematoma, * Loss of consciousness for more than 5 seconds, * Trauma due to serious accident (road accident with passenger ejected from vehicle or death of another person or rollover; pedestrian hit by a moving vehicle; cyclist not wearing a helmet; fall from a height greater than 0.9 meter), * Abnormal behavior in the opinion of parents. * For children 2 years and older (CCT-scan or hospitalization recommended according to physician's evaluation): * Loss of consciousness at time of accident, * Vomiting, * Trauma due to serious accident (road accident with passenger ejected from vehicle or death of another person or rollover; pedestrian hit by a moving vehicle; cyclist not wearing a helmet; fall from a height greater than 1.5 meter), * Severe headache. Exclusion Criteria: * Patient already enrolled in another therapeutic trial with drug administration Down syndrome Melanoma Refusal of child Refusal of parents or legal guardian Trauma more than 3 hours earlier GCS score of 13 or 14, or signs of skull fracture or lesions of the skull base (CCT-scan recommended) Children with TBI not requiring hospitalization and/or CCT-scan as per SFP recommendations (Lorton et al., 2014). This group is defined by the absence of the following criteria: * GCS score different from 15, * Age \< 3 months, * Seriousness of accident: * road accident with passenger ejected from vehicle or death of another person or rollover, * pedestrian hit by a moving vehicle, * cyclist not wearing a helmet. * Fall: * of more than 0.9 m before age 2 years, * of more than 1.5 m after age 2 years. * Loss of consciousness for 5 seconds or more, * Inconsolable crying, * Agitation, drowsiness, feeling "slowed down", obnubilation, * Vomiting or headache, * Facial or cranial hematoma, * Otorrhea, rhinorrhea, * Child under 2 years old, * Loss of consciousness for less than 5 seconds, * Unusual behaviour, * Concern of family members

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Conditions

The condition(s) this trial relates to.

Brain Concussion Craniocerebral Trauma disease traumatic brain injury

As listed by the trial registrant

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

Contacts and locations

Locations

  • Assistance Publique des Hôpitaux de Marseille

    Marseille, 13385, France

  • CHU Clermont-Ferrand

    Clermont-Ferrand, 63003, France

  • Hospices Civils de LYON

    Bron, 69677, France

  • Limoges Teaching hospital

    Limoges, 87042, France

  • Montpellier Teaching hopsital

    Montpellier, 34090, France

  • Nantes Teaching Hospital

    Nantes, 44036, France

  • Nice Teaching Hospital

    Nice, 06200, France

  • Nimes Teaching Hospital

    Nîmes, 30900, France

  • Reims Teaching Hospital

    Reims, 51092, France

  • Saint-Etienne Teaching Hospital

    Saint-Etienne, 42055, France

  • Vichy Hospital Center

    Vichy, 03200, France

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