Informations générales (source: ClinicalTrials.gov)
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 (GUEST)
Observational
Centre Hospitalier Princesse Grace (Voir sur ClinicalTrials)
avril 2024
mars 2026
05 avril 2025
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.
Etablissements
| Les établissements d'Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| GH PARIS SITE SAINT JOSEPH | Camille GERLIER, MD | Contact (sur clinicalTrials) | |||
| Les établissements sans correspondance certaine dans le répertoire FINESS dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| AP-HP Nord Lariboisière - Paris - France | Anthony CHAUVIN, MD | Contact (sur clinicalTrials) | |||
| AP-HP Sorbonne Université, site Pitié-Salpêtrière - Paris - France | Pierre HAUSFATER, MD-PhD | Contact (sur clinicalTrials) | |||
| Centre Hospitalier Universitaire d'Angers - Angers - France | Delphine DOUILLET, MD | Contact (sur clinicalTrials) | |||
| Centre Hospitalier Universitaire de Poitiers - Poitiers - France | Jérémy GUENEZAN, MD | Contact (sur clinicalTrials) | |||
| Hôpital Carémeau - CHU de Nîmes - Nîmes - France | Pierre-Géraut CLARET, MD-PhD | Contact (sur clinicalTrials) | |||
| Hôpital François Mitterrand - CHU de Dijon - Dijon - France | Patrick RAY, MD-PhD | Contact (sur clinicalTrials) | |||
| Hôpital Gabriel-Montpied - CHU de Clermont-Ferrand - Clermont-Ferrand - France | Jeannot SCHMIDT, MD-PhD | Contact (sur clinicalTrials) | |||
| Hôpital Lapeyronie - CHU de Montpellier - Montpellier - France | Xavier BOBBIA, MD-PhD | Contact (sur clinicalTrials) | |||
| Hôpital Nord - CHU de Grenoble-Alpes - Grenoble - France | Damien VIGLINO, MD-PhD | Contact (sur clinicalTrials) | |||
| Hôpital Pasteur CHU de Nice - Nice - France | Céline OCCELI, MD | Contact (sur clinicalTrials) | |||
| Hôpital Trousseau - CHRU Tours - Tours - France | Said LARIBI, MD-PhD | Contact (sur clinicalTrials) | |||
| Hospices Civils de Lyon - Lyon - France | Laurent JACQUIN, MD | Contact (sur clinicalTrials) | |||
| Hôtel Dieu - CHU de Nantes - Nantes - France | Emmanuel MONTASSIER, MD-PhD | Contact (sur clinicalTrials) | |||
Critères
Tous
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
- 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
- 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