Study Assessing Evaluation of the Interest of Serum S100B Protein

Status Completed

Clinical Trial 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.

Clinical Trial Description

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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT02819778
Study type	Interventional
Source	University Hospital, Clermont-Ferrand
Contact
Status	Completed
Phase	N/A
Start date	November 2, 2016
Completion date	May 31, 2022

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Study Assessing Evaluation of the Interest of Serum S100B Protein Determination in the Management of Pediatric Mild Traumatic Brain Injury — PROS100B

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms