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

NCT02819778 | Completed

• 2 other identifiers: CHU-02692016-A00195-46
• Study Type: interventional
• Target: 2,209
• Locations: 1 country
• Sites: 11

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.

Conditions

Craniocerebral Trauma; Pediatrics

Keywords

Diagnosis; Craniocerebral Trauma; Pediatrics; S100B; mild traumatic brain injury

Outcome Measures

Primary Outcomes (1)

• utility of serum S100B measurement in the management of pediatric mTBI

  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.

  at day 1

Secondary Outcomes (7)

• 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 detection of complications

  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

Study Arms (2)

Control group

OTHER

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

Procedure: usual care

interventional group

OTHER

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

Procedure: S100B

Interventions

usual care PROCEDURE

Control group

S100B PROCEDURE

interventional group

Eligibility Criteria

• Age: 0 Years - 16 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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,

Sponsors & Collaborators

• University Hospital, Clermont-Ferrand: lead

Study Sites (11)

Hospices Civils de LYON

Bron, 69677, France

Location

CHU Clermont-Ferrand

Clermont-Ferrand, 63003, France

Location

Limoges Teaching hospital

Limoges, 87042, France

Location

Assistance Publique des Hôpitaux de Marseille

Marseille, 13385, France

Location

Montpellier Teaching hopsital

Montpellier, 34090, France

Location

Nantes Teaching Hospital

Nantes, 44036, France

Location

Nice Teaching Hospital

Nice, 06200, France

Location

Nimes Teaching Hospital

Nîmes, 30900, France

Location

Reims Teaching Hospital

Reims, 51092, France

Location

Saint-Etienne Teaching Hospital

Saint-Etienne, 42055, France

Location

Vichy Hospital Center

Vichy, 03200, France

Location

Related Publications (4)

• 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.

  PMID: 22529109 BACKGROUND

• 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.

  PMID: 10585999 BACKGROUND

• Bouvier D, Cantais A, Laspougeas A, Lorton F, Plenier Y, Cottier M, Fournier P, Tran A, Moreau E, Durif J, Sarret C, Mourgues C, Sturtz F, Oudart JB, Raffort J, Gonzalo P, Cristol JP, Masson D, Pereira B, Sapin V. Serum S100B Level in the Management of Pediatric Minor Head Trauma: A Randomized Clinical Trial. JAMA Netw Open. 2024 Mar 4;7(3):e242366. doi: 10.1001/jamanetworkopen.2024.2366.

  PMID: 38502126 RESULT

• 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.

  PMID: 31129587 DERIVED

MeSH Terms

Conditions

Craniocerebral Trauma; Disease; Brain Concussion

Condition Hierarchy (Ancestors)

Trauma, Nervous System; Nervous System Diseases; Wounds and Injuries; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Brain Injuries, Traumatic; Brain Injuries; Brain Diseases; Central Nervous System Diseases; Head Injuries, Closed; Wounds, Nonpenetrating

Study Officials

• Damien BOUVIER

  University Hospital, Clermont-Ferrand

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 24, 2016
• First Posted: June 30, 2016
• Study Start: November 2, 2016
• Primary Completion: December 8, 2021
• Study Completion: May 31, 2022
• Last Updated: April 21, 2026

Record last verified: 2026-04

Locations

FR (11)