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

NCT05285774 | Completed

• 2 other identifiers: 01-2021-LJ3IDRCB: 2021-A02163-38
• Study Type: observational
• Target: 258
• Locations: 1 country
• Sites: 1

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.

Conditions

Mild Brain Traumatic Injury; Compliance, Patient

Keywords

Protein S100B; Mild brain traumatic injury

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Measurement of the S100B protein for a threshold ≤0.10 µg//l

  At 3 hours after MCT

• Length of hospital stay

  Immediatly after the procedure

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Centre Hospitalier de Douai: lead

Study Sites (1)

Centre Hospitalier de Douai

Douai, NORD, 59507, France

Location

Related Publications (4)

• 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.

  PMID: 2351508 BACKGROUND

• 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.

  PMID: 27026873 BACKGROUND

• 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.

  PMID: 21601568 BACKGROUND

• 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.

  PMID: 20611042 BACKGROUND

MeSH Terms

Conditions

Brain Concussion; Patient Compliance

Condition Hierarchy (Ancestors)

Brain Injuries, Traumatic; Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Head Injuries, Closed; Wounds and Injuries; Wounds, Nonpenetrating; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior

Study Officials

• Justine HERENG

  Centre Hospitalier de Douai

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 25, 2022
• First Posted: March 18, 2022
• Study Start: April 6, 2022
• Primary Completion: August 6, 2023
• Study Completion: August 6, 2023
• Last Updated: August 30, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)