Clinical trial

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

Name

PETEChIA

Description

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.

Trial arms

Trial start

2019-01-27

Estimated PCD

2025-07-27

Trial end

2026-01-27

Status

Recruiting

Phase

Early phase I

Treatment

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

Arms:

S100B protein dosing

Size

720

Primary endpoint

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

3 hours

Eligibility criteria

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, ...)

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE3'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'DIAGNOSTIC', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 720, 'type': 'ESTIMATED'}}

Updated at

2024-01-11

1 organization

1 product

2 indications

Organization

Poitiers University Hospital

Product

S100B protein

Indication

Mild TBI

Indication

Antiplatelet Therapy