Interest of the S100B Protein Assay in Mild Traumatic Brain Injuries at the DOUAI Hospital (PS100BTCL)

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

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.

Study Overview

• Status: Completed
• Conditions: Compliance, Patient; Mild Brain Traumatic Injury

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.

• Study Type: Observational
• Enrollment (Actual): 258

Contacts and Locations

Study Locations

• France
  • Nord
    • Douai, Nord, France, 59507
      • Centre Hospitalier de Douai

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

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

Description

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

Study Plan

How is the study designed?

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Centre Hospitalier de Douai
• Investigators: Principal Investigator: Justine HERENG, Centre Hospitalier de Douai

Publications and helpful links

General Publications

• Tiret L, Hausherr E, Thicoipe M, Garros B, Maurette P, Castel JP, Hatton F. The epidemiology of head trauma in Aquitaine (France), 1986: a community-based study of hospital admissions and deaths. Int J Epidemiol. 1990 Mar;19(1):133-40. doi: 10.1093/ije/19.1.133.
• Mata-Mbemba D, Mugikura S, Nakagawa A, Murata T, Kato Y, Tatewaki Y, Takase K, Kushimoto S, Tominaga T, Takahashi S. Canadian CT head rule and New Orleans Criteria in mild traumatic brain injury: comparison at a tertiary referral hospital in Japan. Springerplus. 2016 Feb 25;5:176. doi: 10.1186/s40064-016-1781-9. eCollection 2016.
• Bouvier D, Castellani C, Fournier M, Dauphin JB, Ughetto S, Breton M, Labbe A, Weinberg AM, Sapin V. Reference ranges for serum S100B protein during the first three years of life. Clin Biochem. 2011 Jul;44(10-11):927-9. doi: 10.1016/j.clinbiochem.2011.05.004. Epub 2011 May 13.
• Unden J, Romner B. Can low serum levels of S100B predict normal CT findings after minor head injury in adults?: an evidence-based review and meta-analysis. J Head Trauma Rehabil. 2010 Jul-Aug;25(4):228-40. doi: 10.1097/HTR.0b013e3181e57e22.

Study record dates

Study Major Dates

• Study Start (Actual): April 6, 2022
• Primary Completion (Actual): August 6, 2023
• Study Completion (Actual): August 6, 2023

Study Registration Dates

• First Submitted: February 25, 2022
• First Submitted That Met QC Criteria: March 15, 2022
• First Posted (Actual): March 18, 2022

Study Record Updates

• Last Update Posted (Actual): August 30, 2023
• Last Update Submitted That Met QC Criteria: August 29, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Keywords: Protein S100B; Mild brain traumatic injury
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Head Injuries, Closed; Wounds, Nonpenetrating; Brain Injuries; Wounds and Injuries; Brain Injuries, Traumatic; Brain Concussion
• Other Study ID Numbers: 01-2021-LJ3; IDRCB: 2021-A02163-38 (Other Identifier: ANSM)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: There isn't a data sharing plan for this research

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No