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

Poitiers University Hospital4 sites in 1 country720 target enrollmentJanuary 25, 2019

ConditionsMinor Traumatic Brain Injury Treatment by Antiplatelet

InterventionsS100B protein dosing

Overview

Phase: Phase 3
Intervention: S100B protein dosing
Conditions: Minor Traumatic Brain Injury
Sponsor: Poitiers University Hospital
Enrollment: 720
Locations: 4
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
Status: Completed
Last Updated: 4 months ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

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.

Registry

clinicaltrials.gov

Start Date

January 25, 2019

End Date

October 28, 2025

Last Updated

4 months ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Poitiers University Hospital

Responsible Party

Sponsor

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, …)

Arms & Interventions

S100B protein dosing

Intervention: S100B protein dosing

Outcomes

Primary Outcomes

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