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Mild Brain Traumatic InjuryPS100BTCLNCT05285774

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

An observational study of Mild Brain Traumatic Injury and Compliance, Patient, run by Centre Hospitalier de Douai at 1 site in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 18 years and older
How many people
258 participants
Where
1 siteFrance
Study dates
6 Apr 2022to 6 Aug 2023
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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

Who may be able to join

  • 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
Show all 9Show fewer
  • Either Age > 65 years old
  • Either patients under anti platelet aggregation
  • Patients informed about the study

Who cannot join

  • 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
Show all 11Show fewer
  • Glasgow Rating <13
  • Unknown MCT Time
  • Unclear patient history
  • Polytraumatized
  • Congenital or acquired coagulopathy

Trial locations and contacts

1 site in 1 country.

France1 site

  • Centre Hospitalier de Douai

    Douai, NORD, 59507

Other trials in France

About this study

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

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.

Read the 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.

Keywords
Protein S100B, Mild brain traumatic injury
Medical subject headings
Brain Concussion, Patient Compliance

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: At 3 hours after MCT

Secondary outcomes (2)

  1. 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.

    Measured: At 3 hours after MCT

  2. Length of hospital stay

    Evaluate the impact of adding this protocol to emergencies on the medical and paramedical team.

    Measured: Immediatly after the procedure

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Mar 2022
  2. Study start6 Apr 2022
  3. Primary completion6 Aug 2023
  4. Study completion6 Aug 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Other
Time perspective
Prospective
Enrolment
258 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05285774
Sponsor's protocol ID
01-2021-LJ3
Other IDs
IDRCB: 2021-A02163-38
Acronym
PS100BTCL
Status last verified
Aug 2023
First submitted
25 Feb 2022
Last updated
30 Aug 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: There isn't a data sharing plan for this research

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.

    PubMed 2351508

  • 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.

    PubMed 27026873

  • 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.

    PubMed 21601568

  • 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.

    PubMed 20611042

Questions about this trial

What is this clinical trial studying?

An observational study of Mild Brain Traumatic Injury and Compliance, Patient, run by Centre Hospitalier de Douai at 1 site in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 30 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Measurement of the S100B protein to the emergency department of the Douai hospital (time frame: At 3 hours after MCT). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05285774, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Aug 2023.

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