ClinicalTrials.Veeva

Menu

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

U

University Hospital, Clermont-Ferrand

Status

Completed

Conditions

Pediatrics
Craniocerebral Trauma

Treatments

Procedure: S100B
Procedure: usual care

Study type

Interventional

Funder types

Other

Identifiers

NCT02819778
CHU-0269
2016-A00195-46 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment

2,209 patients

Sex

All

Ages

Under 16 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Diagnostic

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

2,209 participants in 2 patient groups

Control group
Other group
Description:
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
Treatment:
Procedure: usual care
interventional group
Other group
Description:
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
Treatment:
Procedure: S100B

Trial contacts and locations

11

Loading...

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2025 Veeva Systems