Interest of the S100B Protein Assay in Mild Traumatic Brain Injuries at the DOUAI Hospital

Study Overview
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Brief Summary
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The main objective is to evaluate the feasibility and interest of setting up a protocol for the systematic measurement of the S100B protein in patients with mild traumatic brain injury admitted to the emergency room of Douai hospital in order to reduce the number of unnecessary brain scans. The main evaluation criterion is the percentage of patients admitted to the emergency department of Douai hospital for mild traumatic brain injury, whose protocol for the systematic measurement of the S100B protein would make it possible to avoid the realization of a brain scans for patients with a protein assay S100B ≤ 0.10 µg/L, carried out within 3h of the onset of MCT. The systematic dosage of the S100B protein in the context of mild traumatic brain injury still does not appear in the recommendations for good practice in 2021. This study will contribute to the reflection on the use of the S100B protein in the development of new recommendations for good practice of mild traumatic brain injury support.

Detailed Description
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This is an observational, prospective, monocentric study. This study concerns patients over 18 years of age treated in the emergency room of Douai hospital for mild traumatic brain injury treated within 3 hours following the head trauma according to the Jéle et al classification and who have no history of melanoma. After verification of the patient's eligibility criteria for participation in this study, information relating to the research in order to obtain their authorization to participate in the research. Once authorization has been obtained, an additional tube of blood is collected when drawing blood samples from the patient as part of their care. Data are collected and a brain scan performed during the treatment and this is used to fill in the research data collection sheet. The data used in this research come from the direct questioning of patients. They are recorded on a paper form or in a computerized medical record. When the patient has been included in the trial the relevant data obtained from the direct questioning are taken from the sources indicated above and are entered on a data collection sheet specifically designed for this research. The collection sheet will be placed in a dedicated tray and will be collected each week from the emergency room.The data will be compiled in EXCEL ® software secured by a password. This file is hosted on the Douai hospital center server with restricted access. The files are protected by a password containing 8 characters (uppercase letters, lowercase letters and numbers), known only to the investigator, the person collecting the data, the clinical research assistant in charge of the study and the biostatistician in charge of data analysis. To meet the main objective, the two-sided 95% confidence interval of the observed percentage of patients admitted to the emergency room of the Douai hospital for mild traumatic brain injury with a brain scan classified as avoidable by the S100B protein assay protocol will be calculated by the exact Clopper-Pearson method.

Official Title
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Interest in the Implementation of a Systematic Protocol for the Dosage of the S100B Protein in the Reduction of the Use of Brain Scans for Patients With Mild Traumatic Brain Injury in the Emergency Room of Douai Hospital

Conditions
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Mild Brain Traumatic Injury, Compliance, Patient

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients aged over 18 years having had a traumatic brain within 3h with Glasgow >13 Patients having made a mild traumatic brain injury according to the Jehlé and Al classification: Either, amnesia of the facts > 30 minutes before the MCT (retrograde amnesia) or either, loss of consciousness or amnesia associated with one of the following mechanisms : Either pedestrian knocked down by a vehicle Either patients ejected from a vehicle Either fall from a height > 1 meter Either Age > 65 years old Either patients under anti platelet aggregation Patients informed about the study Exclusion Criteria: Patients with a history of melanoma or in melanoma follow-up care Patients under guardianship or curatorship Patients deprived of liberty (prisoner) Patients not meeting MCT criteria Refusal to participate in the study Refusal to perform brain scan Glasgow Rating <13 Unknown MCT Time Unclear patient history Polytraumatized Congenital or acquired coagulopathy

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Measurement of the S100B protein to the emergency department of the Douai hospital | Percentage of patients admitted to the emergency department of the Douai hospital for MCT, whose protocol for the systematic measurement of the S100B protein would make it possible to avoid the realization of a brain scan for patients with a protein assay s100B ≤ 0.10 µg/L, carried out within 3h of the onset of MCT. | At 3 hours after MCT | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Measurement of the S100B protein for a threshold ≤0.10 µg//l | Performance measures of the S100B protein for a threshold ≤0.10 µg//l: sensitivity, specificity, positive predictive value and negative predictive value. | At 3 hours after MCT | 
| Length of hospital stay | Evaluate the impact of adding this protocol to emergencies on the medical and paramedical team. | Immediatly after the procedure | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Protein S100B, Mild brain traumatic injury