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

NCT ID: NCT03780062

Last Updated: 2025-12-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

720 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-01-25

Study Completion Date

2025-10-28

Brief Summary

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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.

Detailed Description

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Conditions

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Minor Traumatic Brain Injury Treatment by Antiplatelet

Keywords

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S100B protein minor traumatic brain injuries antiplatelet therapy

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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S100B protein dosing

Group Type EXPERIMENTAL

S100B protein dosing

Intervention Type BIOLOGICAL

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

Interventions

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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

Intervention Type BIOLOGICAL

Eligibility Criteria

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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, …)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Poitiers University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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CHU of MONTPELLIER

Montpellier, , France

Site Status

CHU of NICE

Nice, , France

Site Status

La Pité Salpêtrière

Paris, , France

Site Status

CHU of POITIERS

Poitiers, , France

Site Status

Countries

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France

Other Identifiers

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PETEChIA

Identifier Type: -

Identifier Source: org_study_id