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Study Assessing Evaluation of the Interest of Serum S100B Protein Determination in the Management of Pediatric Mild Traumatic Brain Injury (PROS100B)

Primary Purpose

Craniocerebral Trauma, Pediatrics

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
usual care
S100B
Sponsored by
University Hospital, Clermont-Ferrand
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Craniocerebral Trauma focused on measuring Diagnosis, Craniocerebral Trauma, Pediatrics, S100B, mild traumatic brain injury

Eligibility Criteria

0 Years - 16 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Hospices Civils de LYON
  • CHU Clermont-Ferrand
  • Limoges Teaching hospital
  • Assistance Publique des Hôpitaux de Marseille
  • Montpellier Teaching hopsital
  • Nantes Teaching Hospital
  • Nice Teaching Hospital
  • Nimes Teaching Hospital
  • Reims Teaching Hospital
  • Saint-Etienne Teaching Hospital
  • Vichy Hospital Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

Control group

interventional group

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

utility of serum S100B measurement with respect to reduction in the time spent in the pediatric emergency room
utility of serum S100B measurement with respect to reduction in the duration of hospitalization
utility of serum S100B measurement with respect to reduction in radiation exposure (mSv)
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)
utility of serum S100B measurement with respect to absence of intercurrent events at 48 hours and 3 weeks after mTBI
utility of serum S100B measurement with respect to compliance of emergency physicians with the S100B assay
utility of serum S100B measurement with respect to reduction of the cost of management

Full Information

First Posted
June 24, 2016
Last Updated
January 4, 2023
Sponsor
University Hospital, Clermont-Ferrand
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1. Study Identification

Unique Protocol Identification Number
NCT02819778
Brief Title
Study Assessing Evaluation of the Interest of Serum S100B Protein Determination in the Management of Pediatric Mild Traumatic Brain Injury
Acronym
PROS100B
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

2. Study Status

Record Verification Date
May 2022
Overall Recruitment Status
Completed
Study Start Date
November 2, 2016 (Actual)
Primary Completion Date
December 8, 2021 (Actual)
Study Completion Date
May 31, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Clermont-Ferrand

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Craniocerebral Trauma, Pediatrics
Keywords
Diagnosis, Craniocerebral Trauma, Pediatrics, S100B, mild traumatic brain injury

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
2209 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control group
Arm Type
Other
Arm Description
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
Arm Title
interventional group
Arm Type
Other
Arm Description
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
Intervention Type
Procedure
Intervention Name(s)
usual care
Intervention Type
Procedure
Intervention Name(s)
S100B
Primary Outcome Measure Information:
Title
utility of serum S100B measurement in the management of pediatric mTBI
Description
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.
Time Frame
at day 1
Secondary Outcome Measure Information:
Title
utility of serum S100B measurement with respect to reduction in the time spent in the pediatric emergency room
Time Frame
at day 1
Title
utility of serum S100B measurement with respect to reduction in the duration of hospitalization
Time Frame
at day 1
Title
utility of serum S100B measurement with respect to reduction in radiation exposure (mSv)
Time Frame
at day 1
Title
utility of serum S100B measurement with respect to detection of complications
Description
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)
Time Frame
at day 1
Title
utility of serum S100B measurement with respect to absence of intercurrent events at 48 hours and 3 weeks after mTBI
Time Frame
at 48 hours and 3 weeks after mTBI
Title
utility of serum S100B measurement with respect to compliance of emergency physicians with the S100B assay
Time Frame
at day 1
Title
utility of serum S100B measurement with respect to reduction of the cost of management
Time Frame
at day 1

10. Eligibility

Sex
All
Minimum Age & Unit of Time
0 Years
Maximum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Damien BOUVIER
Organizational Affiliation
University Hospital, Clermont-Ferrand
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospices Civils de LYON
City
Bron
ZIP/Postal Code
69677
Country
France
Facility Name
CHU Clermont-Ferrand
City
Clermont-Ferrand
ZIP/Postal Code
63003
Country
France
Facility Name
Limoges Teaching hospital
City
Limoges
ZIP/Postal Code
87042
Country
France
Facility Name
Assistance Publique des Hôpitaux de Marseille
City
Marseille
ZIP/Postal Code
13385
Country
France
Facility Name
Montpellier Teaching hopsital
City
Montpellier
ZIP/Postal Code
34090
Country
France
Facility Name
Nantes Teaching Hospital
City
Nantes
ZIP/Postal Code
44036
Country
France
Facility Name
Nice Teaching Hospital
City
Nice
ZIP/Postal Code
06200
Country
France
Facility Name
Nimes Teaching Hospital
City
Nimes
ZIP/Postal Code
30900
Country
France
Facility Name
Reims Teaching Hospital
City
Reims
ZIP/Postal Code
51092
Country
France
Facility Name
Saint-Etienne Teaching Hospital
City
Saint-Etienne
ZIP/Postal Code
42055
Country
France
Facility Name
Vichy Hospital Center
City
Vichy
ZIP/Postal Code
03200
Country
France

12. IPD Sharing Statement

Citations:
PubMed Identifier
22529109
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.
Results Reference
background
PubMed Identifier
10585999
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.
Results Reference
background
PubMed Identifier
31129587
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.
Results Reference
derived
Links:
URL
http://www.ncbi.nlm.nih.gov/pubmed/22529109
Description
Serum S100B determination in the management of pediatric mild traumatic brain injury.
URL
http://www.ncbi.nlm.nih.gov/pubmed/10585999
Description
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.

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

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