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RECRUITINGOBSERVATIONAL

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

Added Value, Performance and Acceptance of the "GFAP-UCH-L1" Pair in the Evaluation of Subjects with Mild Traumatic Brain Injury (MTBI) At Intermediate Risk of Complications

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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.

Who May Be Eligible (Plain English)

Who May Qualify: - 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 willing to sign a consent form form Who Should NOT Join This Trial: - Person not affiliated or not benefiting from a health insurance scheme. - Person under judicial protection. - Person with restrictions of freedom or subject to Articles L.3212-1 and L.3213-1, and not included in Article L.1122-8 of the French CSP - Blood collection time \> 12 hours - Subjects for which a scan would be carried out systematically, including: - GCS \<13 (moderate or severe trauma), - congenital hemostasis disorders or patient on anti-coagulant treatment, - clinical signs evoking a fracture of the vault or the base of the skull, - more than one episode of vomiting, - post-traumatic convulsion, - focal neurological deficit. - Obstacle to follow-up at D7 - Malignant melanomas Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
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 subject to Articles L.3212-1 and L.3213-1, and not included in Article L.1122-8 of the French CSP * Blood collection time \> 12 hours * Subjects for which a scan would be carried out systematically, including: * GCS \<13 (moderate or severe trauma), * congenital hemostasis disorders or patient on anti-coagulant treatment, * clinical signs evoking a fracture of the vault or the base of the skull, * more than one episode of vomiting, * post-traumatic convulsion, * focal neurological deficit. * Obstacle to follow-up at D7 * Malignant melanomas

Treatments Being Tested

OTHER

UCH-L1 GFAP

measurment of UCH-L1 GFAP within 12 hours in adult patients after a mild traumatic brain injury

Locations (15)

Centre Hospitalier Universitaire d'Angers
Angers, France
Hôpital Gabriel-Montpied - CHU de Clermont-Ferrand
Clermont-Ferrand, France
Hôpital François Mitterrand - CHU de Dijon
Dijon, France
Hôpital Nord - CHU de Grenoble-Alpes
Grenoble, France
Hospices Civils de Lyon
Lyon, France
Hôpital Lapeyronie - CHU de Montpellier
Montpellier, France
Hôtel Dieu - CHU de Nantes
Nantes, France
Hôpital Pasteur CHU de Nice
Nice, France
Hôpital Carémeau - CHU de Nîmes
Nîmes, France
AP-HP Nord Lariboisière
Paris, France
AP-HP Sorbonne Université, site Pitié-Salpêtrière
Paris, France
Hôpital Saint-Joseph
Paris, France
Centre Hospitalier Universitaire de Poitiers
Poitiers, France
Hôpital Trousseau - CHRU Tours
Tours, France
Centre Hospitalier Princesse Grace
Monaco, Monaco