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

Compliance, Patient Clinical Trial

— PS100BTCL  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05285774
• Other study ID #: 01-2021-LJ3
• Secondary ID: IDRCB: 2021-A021
• Status: Completed
• Start date: April 6, 2022
• Est. completion date: August 6, 2023

Study information

• Verified date: August 2023
• Source: Centre Hospitalier de Douai
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 258
• Est. completion date: August 6, 2023
• Est. primary completion date: August 6, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Brain Concussion
• Brain Injuries
• Brain Injuries, Traumatic
• Compliance, Patient
• Wounds and Injuries

Locations

Country	Name	City	State
France	Centre Hospitalier de Douai	Douai	Nord

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier de Douai

Country where clinical trial is conducted

France, 

References & Publications (4)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Length of hospital stay	Evaluate the impact of adding this protocol to emergencies on the medical and paramedical team.	Immediatly after the procedure