NCT05885529

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

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 1,500 (estimated)
• Sponsor: Centre Hospitalier Princesse Grace · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

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.

Conditions

• Traumatic Brain Injury

Interventions

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

Timeline

• Start date: 2024-04-19
• Primary completion: 2025-12-15
• Completion: 2026-03-30
• First posted: 2023-06-02
• Last updated: 2025-02-19

Locations

15 sites across 2 countries: France, Monaco