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Interventional Study Assessing Evaluation of the Interest of Serum S100B Protein Determination in the Management of Pediatric Mild Traumatic Brain Injury
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.
Based on initial results from a previous prospective study, a multicenter interventional study will be necessary to validate the routine use of this biomarker .The ultimate goal is to include serum S100B assay in the current recommendations for m traumatic brain injury (mTBI) management based on the study of Kupperman et al. (2009), as mTBI accounts for 5-8% of pediatric emergency admissions in France (60-100 per 100,000 children). The study of Kuppermann et al. strongly dictated the recommendations for mTBI management by the French Society of Emergency Medicine (SFMU) . Then, from these 2 publications, the French Society of Pediatrics (SFP) redacted their recommendations after adjustment method recommendations for clinical practice, used by the French High Authority of Health (HAS) . The use of serum S100B assay as part of the management of pediatric mTBI should make it possible to reduce the number of additional examinations, in particular a 30% reduction in the number of CCT-scans, with a resultant reduction in radiation exposure, known to be a risk factor for cancer. The study protocol corresponds to a diagnostic prospective, controlled, multicenter study using a randomized stepped wedge cluster design, in which pediatric patients (aged ≤ 16 years) presenting to the pediatric emergency room for mTBI with a GCS score of 15 will benefit from usual care ("conventional management" arm) in the control group, and from S100B management in the interventional group.
Age
0 - 16 years
Sex
ALL
Healthy Volunteers
No
Hospices Civils de LYON
Bron, France
CHU Clermont-Ferrand
Clermont-Ferrand, France
Limoges Teaching hospital
Limoges, France
Assistance Publique des Hôpitaux de Marseille
Marseille, France
Montpellier Teaching hopsital
Montpellier, France
Nantes Teaching Hospital
Nantes, France
Nice Teaching Hospital
Nice, France
Nimes Teaching Hospital
Nîmes, France
Reims Teaching Hospital
Reims, France
Saint-Etienne Teaching Hospital
Saint-Etienne, France
Start Date
November 2, 2016
Primary Completion Date
December 8, 2021
Completion Date
May 31, 2022
Last Updated
January 5, 2023
2,209
ACTUAL participants
usual care
PROCEDURE
S100B
PROCEDURE
Lead Sponsor
University Hospital, Clermont-Ferrand
Data Source & Attribution
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