An observational study in Mild Brain Traumatic Injury and Compliance, Patient, sponsored by Centre Hospitalier de Douai. Completed at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-08-30.
Sponsored by Centre Hospitalier de Douai · Observational
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.
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.
2,113 studies on the registry are indexed under Brain Injuries; 385 are open to participants now.
This study's enrollment of 258 is above the median of 100 across 690 observational studies indexed under Brain Injuries.
Browse Brain Injuries studies →This is the only study on the registry with Centre Hospitalier de Douai as lead sponsor.
Counted across the registry records on this site, refreshed daily.
This study concerns patients aged over 18 years with no history of melanoma and treated in the emergency department of the CHD within 2h30 hours after a traumatic brain injury according to the Jehlé et al classification
Exclusion Criteria:
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.
Time frame: At 3 hours after MCT
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.
Time frame: At 3 hours after MCT
Length of hospital stay
Evaluate the impact of adding this protocol to emergencies on the medical and paramedical team.
Time frame: Immediatly after the procedure
Plan to share: No — There isn't a data sharing plan for this research
This study is completed, as verified in Aug 2023. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.