NCT05885529 Glial Fibrillary Acidic Protein (GFAP) and Ubiquitin Carboxy-terminal Hydrolase L1 (UCH-L1) to Exclude Lesions Linked to Significant Traumatic Brain Injuries
| NCT ID | NCT05885529 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Centre Hospitalier Princesse Grace |
| Condition | Traumatic Brain Injury |
| Study Type | OBSERVATIONAL |
| Enrollment | 1,500 participants |
| Start Date | 2024-04-19 |
| Primary Completion | 2025-12-15 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 1,500 participants in total. It began in 2024-04-19 with a primary completion date of 2025-12-15.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 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
Contact & Investigator
Pierre HAUSFATER, MD-PhD
STUDY DIRECTOR
Assistance Publique - Hôpitaux de Paris
Frequently Asked Questions
Who can join the NCT05885529 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Traumatic Brain Injury. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05885529 currently recruiting?
Yes, NCT05885529 is actively recruiting participants. Contact the research team at yann-erick.claessens@chpg.mc for enrollment information.
Where is the NCT05885529 trial being conducted?
This trial is being conducted at Angers, France, Clermont-Ferrand, France, Dijon, France, Grenoble, France and 11 additional locations.
Who is sponsoring the NCT05885529 clinical trial?
NCT05885529 is sponsored by Centre Hospitalier Princesse Grace. The principal investigator is Pierre HAUSFATER, MD-PhD at Assistance Publique - Hôpitaux de Paris. The trial plans to enroll 1,500 participants.