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
Centre Hospitalier Princesse Grace
1,500 participants
Apr 19, 2024
OBSERVATIONAL
Conditions
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
Inclusion Criteria12
- 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 Criteria13
- 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
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Interventions
measurment of UCH-L1 GFAP within 12 hours in adult patients after a mild traumatic brain injury
Locations(15)
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NCT05885529