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| ID | Type | Description | Link |
|---|---|---|---|
| 2016-A00195-46 | Other Identifier | 2016-A00195-46 |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| usual care | Procedure |
| ||
| S100B |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| utility of serum S100B measurement with respect to reduction in the time spent in the pediatric emergency room | at day 1 | |
| utility of serum S100B measurement with respect to reduction in the duration of hospitalization | at day 1 |
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Inclusion Criteria:
GCS score of 15 classically requiring hospitalization and/or CCT-scan as per SFP recommendations (Lorton et al., 2014). These criteria are:
Exclusion Criteria:
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:
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| Name | Affiliation | Role |
|---|---|---|
| Damien BOUVIER | University Hospital, Clermont-Ferrand | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospices Civils de LYON | Bron | 69677 | France | |||
| CHU Clermont-Ferrand |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22529109 | Background | 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. | |
| 10585999 | Background | 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. |
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| utility of serum S100B measurement with respect to reduction in radiation exposure (mSv) | 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) | at day 1 |
| 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 |
| utility of serum S100B measurement with respect to compliance of emergency physicians with the S100B assay | at day 1 |
| utility of serum S100B measurement with respect to reduction of the cost of management | at day 1 |
| Clermont-Ferrand |
| 63003 |
| France |
| Limoges Teaching hospital | Limoges | 87042 | France |
| Assistance Publique des Hôpitaux de Marseille | Marseille | 13385 | France |
| Montpellier Teaching hopsital | Montpellier | 34090 | France |
| Nantes Teaching Hospital | Nantes | 44036 | France |
| Nice Teaching Hospital | Nice | 06200 | France |
| Nimes Teaching Hospital | Nîmes | 30900 | France |
| Reims Teaching Hospital | Reims | 51092 | France |
| Saint-Etienne Teaching Hospital | Saint-Etienne | 42055 | France |
| Vichy Hospital Center | Vichy | 03200 | France |
| 38502126 | Result | 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. |
| 31129587 | Derived | 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. |
| ID | Term |
|---|---|
| D006259 | Craniocerebral Trauma |
| D004194 | Disease |
| D001924 | Brain Concussion |
| ID | Term |
|---|---|
| D020196 | Trauma, Nervous System |
| D009422 | Nervous System Diseases |
| D014947 | Wounds and Injuries |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D000070642 | Brain Injuries, Traumatic |
| D001930 | Brain Injuries |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D016489 | Head Injuries, Closed |
| D014949 | Wounds, Nonpenetrating |
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