Study Assessing Evaluation of the Interest of Serum S100B Protein Determination in the Management of Pediatric Mild Traumatic Brain Injury
- Conditions
- Craniocerebral TraumaPediatrics
- Registration Number
- NCT02819778
- Lead Sponsor
- University Hospital, Clermont-Ferrand
- Brief 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.
- Detailed 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 2209
- 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.
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method utility of serum S100B measurement in the management of pediatric mTBI at day 1 Evaluate the utility of serum S100B measurement in the management of pediatric mTBI by demonstrating a decrease in the proportion of CCT-scan prescribed in the "S100B management" intervention arm compared with the "conventional management" control arm, hypothesizing a 30% decrease in the number of CCT-scan between the intervention versus control arms.
- Secondary Outcome Measures
Name Time Method utility of serum S100B measurement with respect to detection of complications at day 1 detection of complications (intracranial lesions) by CCT-scan which can occur at a rate of 0-7% in patients with mTBI (American Academy of Pediatrics, 1999)
utility of serum S100B measurement with respect to compliance of emergency physicians with the S100B assay at day 1 utility of serum S100B measurement with respect to absence of intercurrent events at 48 hours and 3 weeks after mTBI at 48 hours and 3 weeks after mTBI utility of serum S100B measurement with respect to reduction in the time spent in the pediatric emergency room at day 1 utility of serum S100B measurement with respect to reduction in the duration of hospitalization at day 1 utility of serum S100B measurement with respect to reduction in radiation exposure (mSv) at day 1 utility of serum S100B measurement with respect to reduction of the cost of management at day 1
Trial Locations
- Locations (11)
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
🇫🇷Nimes, France
Reims Teaching Hospital
🇫🇷Reims, France
Saint-Etienne Teaching Hospital
🇫🇷Saint-Etienne, France
Scroll for more (1 remaining)Hospices Civils de LYON🇫🇷Bron, France