CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 2,209 enrolled
Drug / intervention
usual care +1 moreprocedure
Likely dose
Not stated in record
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Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02819778
NCT02819778N/ACompleted

Interventional Study Assessing Evaluation of the Interest of Serum S100B Protein Determination in the Management of Pediatric Mild Traumatic Brain Injury

University Hospital, Clermont-Ferrand·interventional·Posted Jun 30, 2016·Updated Apr 21, 2026

In Brief

A clinical study evaluating usual care and S100B for Craniocerebral Trauma and Pediatrics. Completed, enrolled 2,209 participants across 11 sites.

Detailed Summary

Mild traumatic brain injury (mTBI) is a very common reason for presentation to pediatric emergency departments. So as not to overlook the risk of complications, which occur at a rate of 0-7%, measures such as cranial computed tomography (CCT-scan) and/or short inpatient observation are prescribed. Ultimately, the majority of these measures could be avoided and a large Australian cohort shows that the risk of brain tumors is 2.44 times higher for children who had a CCT-scan (3.24 for age 1-4 years). Assay of a sensitive biomarker in blood, such as the S100B protein, has the potential to reduce the number of these unnecessary measures.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesFrance
Collaborators--

Timeline

N/ACompletedFinished
2017201820192020202120222023202420252026
First PostedJun 30, 2016
Enrollment StartNov 2, 2016
Primary CompletionDec 8, 2021
Study CompletionMay 31, 2022
TodayJul 2, 2026
Enrollment to primary: 5.1 yearsPosted 10.0 years ago

Interventions

usual careprocedure

S100Bprocedure