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

Study Overview
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Brief Summary
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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.

Detailed Description
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Main study The main study includes subjects presenting to the emergency department within 12 hours of mild traumatic brain injury with an intermediate risk of clinical worsening or intracranial lesions. The participants have at least one of the following characteristics, as defined in the French recommendations > 65 years treated with anti-platelet agents Glasgow Score < 15 at 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 The study includes clinical sites in France and Monaco. Participants have a blood sample and a brain scan as part of the care. The participation of subjects in the study will not influence their treatment. Ancillary study The ancillary study uses qualitative research methodology to assess acceptance by physicians and patients of a biological test rather than a CT scan to exclude intracranial complication after mild traumatic brain injury. The study will takes place in the emergency department of the Nice University Hospital Center (CHU of Nice). It will include 30 subjects: 15 subjects presenting to the emergency room for mild traumatic brain injury and included in the main protocol and 15 prescribing emergency physicians. The participation of subjects in the study will not influence their treatment.

Official Title
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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

Conditions
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Traumatic Brain Injury

Intervention / Treatment
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* Other: UCH-L1 GFAP


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| consecutive participants in the 15 centers<br>adult patients with mild traumatic brain injury admitted within 12 hours after the trauma. No interventions, observational study | Other: UCH-L1 GFAP<br>* measurment of UCH-L1 GFAP within 12 hours in adult patients after a mild traumatic brain injury<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| performance of UCH-L1 and GFAP combined to rule out intracranial complication after MTBI | Percentage of intracranial lesion excluded by UCH-L1 and GFAP combined, versus the CT scan, within the first 12 hours following a MTBI | during the first 12 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Performance of UCH-L1 and GFAP combined to rule out intracranial bleeding after MTBI | Percentage of intracranial bleeding excluded by UCH-L1 and GFAP alone or combined, versus the CT scan, within the first 12 hours following a MTBI | during the first 12 hours | 
| Performance of UCH-L1 and GFAP combined to rule out intracranial bleeding after MTBI | Percentage of intracranial lesion excluded by UCH-L1 and GFAP alone or combined, versus the CT scan, within the first 12 hours following a MTBI . | during the first 12 hours with a focus every 3 hours | 
| Comparation of UCH-L1 and GFAP combined or alone, to S100b protein (PS100b) | Percentage of intracranial complication identified by UCH-L1 and GFAP, alone or in combination, versus PS100b within the first 12 hours following a MTBI . | during the first 12 hours with a focus every 3 hours | 
| Predicted impact of using UCH-L1 and GFAP combined | Variation of resource consumption by the use of UCH-L1 and GFAP | day 7 | 
| Performance of UCHL-1 and GFAP alone or combined to predict complications | Percentage of complications avoided by the use of UCH-L1 and GFAP, alone or combined. | during the first 7 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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UCHL1, GFAP, CT scan