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

Pediatrics Clinical Trial

— PROS100B  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02819778
• Other study ID #: CHU-0269
• Secondary ID: 2016-A00195-46
• Status: Completed
• Phase: N/A
• Start date: November 2, 2016
• Est. completion date: May 31, 2022

Study information

• Verified date: May 2022
• Source: University Hospital, Clermont-Ferrand
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 2209
• Est. completion date: May 31, 2022
• Est. primary completion date: December 8, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 0 Years to 16 Years

Eligibility

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

Related Conditions & MeSH terms

• Brain Concussion
• Brain Injuries
• Brain Injuries, Traumatic
• Craniocerebral Trauma
• Pediatrics

Intervention

Procedure:
• usual care

• S100B

Locations

Country	Name	City	State
France	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	Vichy Hospital Center	Vichy

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Clermont-Ferrand

Country where clinical trial is conducted

France, 

References & Publications (2)

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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	utility of serum S100B measurement with respect to reduction in the time spent in the pediatric emergency room		at day 1
Secondary	utility of serum S100B measurement with respect to reduction in the duration of hospitalization		at day 1
Secondary	utility of serum S100B measurement with respect to reduction in radiation exposure (mSv)		at day 1
Secondary	utility of serum S100B measurement with respect to detection of complications	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)	at day 1
Secondary	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
Secondary	utility of serum S100B measurement with respect to compliance of emergency physicians with the S100B assay		at day 1
Secondary	utility of serum S100B measurement with respect to reduction of the cost of management		at day 1

External Links

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