Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02819778
Recruitment Status : Recruiting
First Posted : June 30, 2016
Last Update Posted : October 25, 2018
Sponsor:
Information provided by (Responsible Party):
University Hospital, Clermont-Ferrand

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.

Condition or disease Intervention/treatment Phase
Craniocerebral Trauma Pediatrics Procedure: usual care Procedure: S100B Not Applicable

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.


Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 4000 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Interventional Study Assessing Evaluation of the Interest of Serum S100B Protein Determination in the Management of Pediatric Mild Traumatic Brain Injury
Actual Study Start Date : November 2, 2016
Estimated Primary Completion Date : April 30, 2020
Estimated Study Completion Date : December 31, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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
Procedure: usual care
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
Procedure: S100B



Primary Outcome Measures :
  1. utility of serum S100B measurement in the management of pediatric mTBI [ Time Frame: at day 1 ]
    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 :
  1. utility of serum S100B measurement with respect to reduction in the time spent in the pediatric emergency room [ Time Frame: at day 1 ]
  2. utility of serum S100B measurement with respect to reduction in the duration of hospitalization [ Time Frame: at day 1 ]
  3. utility of serum S100B measurement with respect to reduction in radiation exposure (mSv) [ Time Frame: at day 1 ]
  4. utility of serum S100B measurement with respect to detection of complications [ Time Frame: at day 1 ]
    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)

  5. 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 ]
  6. utility of serum S100B measurement with respect to compliance of emergency physicians with the S100B assay [ Time Frame: at day 1 ]
  7. utility of serum S100B measurement with respect to reduction of the cost of management [ Time Frame: at day 1 ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   up to 16 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02819778


Contacts
Layout table for location contacts
Contact: Lise LACLAUTRE 04 73 75 49 63 drci@chu-clermontferrand.fr

Locations
Layout table for location information
France
Hospices Civils de LYON Recruiting
Bron, France, 69677
CHU Clermont-Ferrand Recruiting
Clermont-Ferrand, France, 63003
Contact: Lise LACLAUTRE    04 73 75 49 63    drci@chu-clermontferrand.fr   
Principal Investigator: Damien BOUVIER         
Limoges Teaching hospital Recruiting
Limoges, France, 87042
Assistance Publique des Hôpitaux de Marseille Recruiting
Marseille, France, 13385
Montpellier Teaching hopsital Recruiting
Montpellier, France, 34090
Nice Teaching Hospital Recruiting
Nice, France, 06200
Reims Teaching Hospital Recruiting
Reims, France, 51092
Saint-Etienne Teaching Hospital Recruiting
Saint-Etienne, France, 42055
Sponsors and Collaborators
University Hospital, Clermont-Ferrand
Investigators
Layout table for investigator information
Principal Investigator: Damien BOUVIER University Hospital, Clermont-Ferrand

Additional Information:
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: University Hospital, Clermont-Ferrand
ClinicalTrials.gov Identifier: NCT02819778     History of Changes
Other Study ID Numbers: CHU-0269
2016-A00195-46 ( Other Identifier: 2016-A00195-46 )
First Posted: June 30, 2016    Key Record Dates
Last Update Posted: October 25, 2018
Last Verified: October 2018

Keywords provided by University Hospital, Clermont-Ferrand:
Diagnosis
Craniocerebral Trauma
Pediatrics
S100B
mild traumatic brain injury

Additional relevant MeSH terms:
Layout table for MeSH terms
Brain Injuries
Brain Injuries, Traumatic
Brain Concussion
Craniocerebral Trauma
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Trauma, Nervous System
Wounds and Injuries
Head Injuries, Closed
Wounds, Nonpenetrating