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

NCT ID: NCT02819778

Last Updated: 2023-01-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 2209 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-11-02
• Study Completion Date: 2022-05-31

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.

Conditions

Craniocerebral Trauma; Pediatrics

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Control group

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

Group Type: OTHER

usual care

Intervention Type: PROCEDURE

interventional group

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

Group Type: OTHER

S100B

Intervention Type: PROCEDURE

Interventions

usual care

Intervention Type: PROCEDURE

S100B

Intervention Type: PROCEDURE

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

• Minimum Eligible Age: 0 Years
• Maximum Eligible Age: 16 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Clermont-Ferrand

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Damien BOUVIER

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Clermont-Ferrand

Locations

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

Nîmes, , France

Reims Teaching Hospital

Reims, , France

Saint-Etienne Teaching Hospital

Saint-Etienne, , France

Vichy Hospital Center

Vichy, , France

Countries

France

References

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.

Reference Type: BACKGROUND

PMID: 22529109 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 10585999 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 38502126 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 31129587 (View on PubMed)

Related Links

http://www.ncbi.nlm.nih.gov/pubmed/22529109

Serum S100B determination in the management of pediatric mild traumatic brain injury.

http://www.ncbi.nlm.nih.gov/pubmed/10585999

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.

Other Identifiers

2016-A00195-46

Identifier Type: OTHER

Identifier Source: secondary_id

CHU-0269

Identifier Type: -

Identifier Source: org_study_id