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RecruitingNCT05885529

Glial Fibrillary Acidic Protein (GFAP) and Ubiquitin Carboxy-terminal Hydrolase L1 (UCH-L1) to Exclude Lesions Linked to Significant Traumatic Brain Injuries

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Trial Parameters

ConditionTraumatic Brain Injury
SponsorCentre Hospitalier Princesse Grace
Study TypeOBSERVATIONAL
PhaseN/A
Enrollment1,500
SexALL
Min Age18 Years
Max AgeN/A
Start Date2024-04-19
Completion2025-12-15
Interventions
UCH-L1 GFAP

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Brief Summary

The goal of this observational study is to evaluate the performance of UCH-L1 and GFAP combined in patients with a mild traumatic brain injury. The main question : • Does the combination of UCH-L1 and GFAP can exclude brain injuries detected with CT scan in the first twelve hours after a mild traumatic brain injury? Participants will do the exams planed in routine care and : * during the expected blood sampling an additional blood sample will be done, * seven days after the discharge a call will be done by the investigator.

Eligibility Criteria

Inclusion Criteria: * Traumatic brain injury defined by * Impact on the skull or the face AND OR * Acceleration / deceleration * Glasgow Coma Scal 13, 14 or 15 * One of the following 4 criteria: * \> 65 years treated with anti-platelet agent, * GCS \< 15 two hours after the trauma if associated intoxication (alcohol, narcotic, psychotropic), * Trauma with high kinetics (for information only: a risk mechanism (pedestrian knocked down by a motorized vehicle, ejection from a vehicle, fall from more than 3 steps (more than one meter), etc.), * Amnesia of facts \> 30 min before the trauma. * Having a blood sample taken as part of care with a delay between the clinical event and the biological sample \< 12 hours * Having a CT-scan prescription as part of the MTBI evaluation * Patient who signed an informed consent form Exclusion Criteria: * Person not affiliated or not benefiting from a health insurance scheme. * Person under judicial protection. * Person with restrictions of freedom or subj

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