Clinical trial NCT02819778: Study Assessing Evaluation of the Interest of Serum S100B Protein Determination in the Management of Pediatric Mild Traumatic Brain Injury
Official title: Interventional Study Assessing Evaluation of the Interest of Serum S100B Protein Determination in the Management of Pediatric Mild Traumatic Brain Injury
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Craniocerebral Trauma
Pediatrics
Keywords: Diagnosis
Craniocerebral Trauma
Pediatrics
S100B
mild traumatic brain injury
Lead sponsor: University Hospital, Clermont-Ferrand
Sponsor class: OTHER
First posted: 2016-06-30
Enrollment: 2209
Sex: ALL
Minimum age (years): 0
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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.

Eligibility criteria: 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

Primary outcomes:
measure: utility of serum S100B measurement in the management of pediatric mTBI
timeFrame: at day 1
Secondary outcomes:
measure: utility of serum S100B measurement with respect to reduction in the time spent in the pediatric emergency room
timeFrame: at day 1
measure: utility of serum S100B measurement with respect to reduction in the duration of hospitalization
timeFrame: at day 1
measure: utility of serum S100B measurement with respect to reduction in radiation exposure (mSv)
timeFrame: at day 1
measure: utility of serum S100B measurement with respect to detection of complications
timeFrame: at day 1
measure: utility of serum S100B measurement with respect to absence of intercurrent events at 48 hours and 3 weeks after mTBI
timeFrame: at 48 hours and 3 weeks after mTBI
measure: utility of serum S100B measurement with respect to compliance of emergency physicians with the S100B assay
timeFrame: at day 1
measure: utility of serum S100B measurement with respect to reduction of the cost of management
timeFrame: at day 1
Other outcomes:
Locations:
city: Bron
country: France
facility: Hospices Civils de LYON
city: Clermont-Ferrand
country: France
facility: CHU Clermont-Ferrand
city: Limoges
country: France
facility: Limoges Teaching hospital
city: Marseille
country: France
facility: Assistance Publique des Hôpitaux de Marseille
city: Montpellier
country: France
facility: Montpellier Teaching hopsital
city: Nantes
country: France
facility: Nantes Teaching Hospital
city: Nice
country: France
facility: Nice Teaching Hospital
city: Nimes
country: France
facility: Nimes Teaching Hospital
city: Reims
country: France
facility: Reims Teaching Hospital
city: Saint-Etienne
country: France
facility: Saint-Etienne Teaching Hospital
city: Vichy
country: France
facility: Vichy Hospital Center
Study officials:
affiliation: University Hospital, Clermont-Ferrand
name: Damien BOUVIER
role: PRINCIPAL_INVESTIGATOR
References:
citation: Bouvier D, Fournier M, Dauphin JB, Amat F, Ughetto S, Labbe A, Sapin V. Serum S100B determination in the management of pediatric mild traumatic brain injury. Clin Chem. 2012 Jul;58(7):1116-22. doi: 10.1373/clinchem.2011.180828. Epub 2012 Apr 23.
citation: The management of minor closed head injury in children. Committee on Quality Improvement, American Academy of Pediatrics. Commission on Clinical Policies and Research, American Academy of Family Physicians. Pediatrics. 1999 Dec;104(6):1407-15.
citation: Bouvier D, Balayssac D, Durif J, Mourgues C, Sarret C, Pereira B, Sapin V. Assessment of the advantage of the serum S100B protein biomonitoring in the management of paediatric mild traumatic brain injury-PROS100B: protocol of a multicentre unblinded stepped wedge cluster randomised trial. BMJ Open. 2019 May 24;9(5):e027365. doi: 10.1136/bmjopen-2018-027365.