Craniocerebral TraumaPROS100BNCT02819778
Study Assessing Evaluation of the Interest of Serum S100B Protein Determination in the Management of Pediatric Mild Traumatic Brain Injury
A study testing S100B in people with Craniocerebral Trauma and Pediatrics, run by University Hospital, Clermont-Ferrand at 11 sites in France.
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. Read more about this study
- Who is it for?
- Ages 0 to 16 years
- Conditions the study is for
- Craniocerebral Trauma, Pediatrics
- What is being tested?
- S100B
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,209 participants
- Where
- 11 sitesFrance
- Study dates
- 2 Nov 2016to 31 May 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 0 to 16 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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),
Show all 12Show fewer
- 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.
Who cannot join
- 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,
Show all 21Show fewer
- 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
Trial locations and contacts
11 sites in 1 country.
11 sites in 1 country
France11 sites
Hospices Civils de LYON
Bron, 69677
CHU Clermont-Ferrand
Clermont-Ferrand, 63003
Limoges Teaching hospital
Limoges, 87042
Assistance Publique des Hôpitaux de Marseille
Marseille, 13385
Montpellier Teaching hopsital
Montpellier, 34090
Nantes Teaching Hospital
Nantes, 44036
Nice Teaching Hospital
Nice, 06200
Nimes Teaching Hospital
Nîmes, 30900
Reims Teaching Hospital
Reims, 51092
Saint-Etienne Teaching Hospital
Saint-Etienne, 42055
Vichy Hospital Center
Vichy, 03200
About this study
Official title: Interventional Study Assessing Evaluation of the Interest of Serum S100B Protein Determination in the Management of Pediatric Mild Traumatic Brain Injury
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.
Read the 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
- Being tested
- usual care, S100B
- Keywords
- Diagnosis, Craniocerebral Trauma, Pediatrics, S100B, mild traumatic brain injury
- Medical subject headings
- Craniocerebral Trauma, Disease, Brain Concussion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
usual careProcedure or surgery
S100BProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Procedure: S100B |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: at day 1
Secondary outcomes (7)
utility of serum S100B measurement with respect to reduction in the time spent in the pediatric emergency room
Measured: at day 1
utility of serum S100B measurement with respect to reduction in the duration of hospitalization
Measured: at day 1
utility of serum S100B measurement with respect to reduction in radiation exposure (mSv)
Measured: at day 1
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)
Measured: at day 1
utility of serum S100B measurement with respect to absence of intercurrent events at 48 hours and 3 weeks after mTBI
Measured: at 48 hours and 3 weeks after mTBI
utility of serum S100B measurement with respect to compliance of emergency physicians with the S100B assay
Measured: at day 1
utility of serum S100B measurement with respect to reduction of the cost of management
Measured: at day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jun 2016 (estimated)
- Study start2 Nov 2016
- Primary completion8 Dec 2021
- Study completion31 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Craniocerebral TraumaStudies of the same condition, open and under way.
- More trials run by University Hospital, Clermont-FerrandThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 2,209 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Clermont-Ferrand
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Damien BOUVIER, Principal investigator, University Hospital, Clermont-Ferrand
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02819778
- Sponsor's protocol ID
- CHU-0269
- Other IDs
- 2016-A00195-46
- Acronym
- PROS100B
- Status last verified
- Apr 2026
- First submitted
- 24 Jun 2016
- Last updated
- 21 Apr 2026
- Results posted
- No
Publications
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.
PubMed 22529109The 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.
PubMed 10585999Bouvier 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.
PubMed 38502126Bouvier 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.
PubMed 31129587
Study at a glance
From the registry record, last updated by the sponsor on 21 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Interventional Study Assessing Evaluation of the Interest of Serum S100B Protein Determination in the Management of Pediatric Mild Traumatic Brain Injury
- ClinicalTrials.gov ID
- NCT02819778
- Acronym / sponsor ID
- PROS100B / CHU-0269
- Conditions
- Craniocerebral Trauma, Pediatrics
- Keywords
- Diagnosis, Craniocerebral Trauma, Pediatrics, S100B, mild traumatic brain injury
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2,209 participants (actual)
- Lead sponsor
- University Hospital, Clermont-FerrandUniversity, hospital or other
- Study start
- 2 Nov 2016 (actual)
- Primary completion
- 8 Dec 2021 (actual)
- Study completion
- 31 May 2022 (actual)
- First posted
- 30 Jun 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control group | Other | Procedure: usual careThe 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 |
| interventional group | Other | Procedure: S100BThe 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 |
Who may qualify
- Ages
- 0 to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (12 listed)
- 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,
Key exclusion criteria (21 listed)
- 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:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| usual care | Procedure or surgery | Control group |
| S100B | Procedure or surgery | interventional group |
Primary outcome
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.
7 secondary outcomes
utility of serum S100B measurement with respect to reduction in the time spent in the pediatric emergency room
Time frame: at day 1
utility of serum S100B measurement with respect to reduction in the duration of hospitalization
Time frame: at day 1
utility of serum S100B measurement with respect to reduction in radiation exposure (mSv)
Time frame: at day 1
utility of serum S100B measurement with respect to detection of complications
Time frame: at day 1
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
utility of serum S100B measurement with respect to compliance of emergency physicians with the S100B assay
Time frame: at day 1
utility of serum S100B measurement with respect to reduction of the cost of management
Time frame: at day 1
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Apr 2026.
- Background: PubMed 22529109Bouvier 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.
- Background: PubMed 10585999The 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 publication: PubMed 38502126Bouvier 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.
- Derived from this study: PubMed 31129587Bouvier 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Damien BOUVIER principal investigator
University Hospital, Clermont-Ferrand
11 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing S100B in people with Craniocerebral Trauma and Pediatrics, run by University Hospital, Clermont-Ferrand at 11 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
utility of serum S100B measurement in the management of pediatric mTBI (time frame: at day 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02819778, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Apr 2026.