Interest of the S100B Protein Assay in Mild Traumatic Brain Injuries at the DOUAI Hospital
- Conditions
- Mild Brain Traumatic InjuryCompliance, Patient
- Registration Number
- NCT05285774
- Lead Sponsor
- Centre Hospitalier de Douai
- Brief Summary
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
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 258
- 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
- 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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Measurement of the S100B protein to the emergency department of the Douai hospital At 3 hours after MCT 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.
- Secondary Outcome Measures
Name Time Method Measurement of the S100B protein for a threshold ≤0.10 µg//l At 3 hours after MCT Performance measures of the S100B protein for a threshold ≤0.10 µg//l: sensitivity, specificity, positive predictive value and negative predictive value.
Length of hospital stay Immediatly after the procedure Evaluate the impact of adding this protocol to emergencies on the medical and paramedical team.
Trial Locations
- Locations (1)
Centre Hospitalier de Douai
🇫🇷Douai, Nord, France