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

Recruiting now

Conditions studied: Traumatic Brain Injury

In brief

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.

Key facts

Study ID

NCT05885529

Run by

Centre Hospitalier Princesse Grace

People needed

1500

Starts

2024-04-19

Expected to finish

2026-03-30

Last updated by the study team

2025-02-19

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

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

Full record on ClinicalTrials.gov

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