Interest of S100B Protein for Patient Victim of Minor Traumatic Brain Injury and Treated by Antiplatelet (PETEChIA)

December 19, 2025 updated by: Poitiers University Hospital

All the patients admitted in emergency department for minor traumatized cranial, with antiplatelet therapy, can be included, after checked inclusion and non inclusions criterias. If they are agree, a blood sample for the dosage of S100b will be done.

No other modification of the medical care, all patients will have tomodensitometria, according with recommendations. The aim of the study is to validate the negative predictive value of S100b in this population.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

720

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Montpellier, France, 34090
        • CHU of Montpellier
      • Nice, France, 06003
        • CHU of Nice
      • Paris, France, 75013
        • La Pité Salpêtrière
      • Poitiers, France, 86021
        • CHU of POITIERS

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Age > 18 Years old
  • Minor traumatic brain injury measured by a Glasgow score between 13 and 15
  • Antiplatelet agent therapy
  • Free subject without tutorship or curatorship

Exclusion Criteria:

  • Age < 18 years old
  • Glasgow score <13
  • Traumatic brain injury older than 6 hours
  • Patient without any social security system
  • Patient with renforced protection (tutorship, curatorship, …)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: S100B protein dosing
Biological: S100B protein dosing
Patients under antiplatelet therapy and who have a minor traumatic brain injury will have a blood samples with protein S100B dosage on arrival to the emergency room and after they will have a brain scanner between 4 and 8 hours after the trauma to analyse the negative predictive value with a treshold of 0.105 μg/L

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Brain scanner Detection of a cerebral lesion requiring a surgery or medical intervention or an hospitalisation for a patient who have serum level of S100B protein with the treshold of 0.105 μg/L
Time Frame: 3 hours
3 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Poitiers University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 25, 2019

Primary Completion (Actual)

April 28, 2025

Study Completion (Actual)

October 28, 2025

Study Registration Dates

First Submitted

December 17, 2018

First Submitted That Met QC Criteria

December 17, 2018

First Posted (Actual)

December 19, 2018

Study Record Updates

Last Update Posted (Estimated)

December 29, 2025

Last Update Submitted That Met QC Criteria

December 19, 2025

Last Verified

December 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PETEChIA

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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