Blood test may spare kids from unneeded radiation after head bumps
NCT ID NCT02819778
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
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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
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2,209 people
The number who actually took part.
- Started
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Nov 2016
- Finished
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May 2022
- Lead sponsor
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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
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0 to 16 years
- Sex
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Anyone
- Healthy volunteers
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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 Hide 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.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Assistance Publique des Hôpitaux de Marseille
Marseille, 13385, France
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CHU Clermont-Ferrand
Clermont-Ferrand, 63003, France
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Hospices Civils de LYON
Bron, 69677, France
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Limoges Teaching hospital
Limoges, 87042, France
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Montpellier Teaching hopsital
Montpellier, 34090, France
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Nantes Teaching Hospital
Nantes, 44036, France
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Nice Teaching Hospital
Nice, 06200, France
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Nimes Teaching Hospital
Nîmes, 30900, France
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Reims Teaching Hospital
Reims, 51092, France
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Saint-Etienne Teaching Hospital
Saint-Etienne, 42055, France
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Vichy Hospital Center
Vichy, 03200, France
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