Actively Recruiting
Glial Fibrillary Acidic Protein (GFAP) and Ubiquitin Carboxy-terminal Hydrolase L1 (UCH-L1) to Exclude Lesions Linked to Significant Traumatic Brain Injuries
Led by Centre Hospitalier Princesse Grace · Updated on 2025-02-19
1500
Participants Needed
15
Research Sites
101 weeks
Total Duration
On this page
Sponsors
C
Centre Hospitalier Princesse Grace
Lead Sponsor
B
BioMérieux
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Glial Fibrillary Acidic Protein (GFAP) and Ubiquitin Carboxy-terminal Hydrolase L1 (UCH-L1) to Exclude Lesions Linked to Significant Traumatic Brain Injuries
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Traumatic brain injury defined by impact on the skull or face and/or acceleration/deceleration
- Glasgow Coma Scale score of 13, 14, or 15
- One of the following: over 65 years treated with anti-platelet agents, GCS less than 15 two hours after trauma if intoxicated, high kinetic trauma, or amnesia over 30 minutes before trauma
- Blood sample taken within 12 hours of the clinical event
- CT scan prescribed as part of MTBI evaluation
- Signed informed consent form
You will not qualify if you...
- Not affiliated with or not covered by a health insurance scheme
- Under judicial protection
- Subject to legal restrictions on freedom (specific French legal articles)
- Blood collection more than 12 hours after injury
- Moderate or severe trauma (GCS less than 13)
- Congenital bleeding disorders or on anti-coagulant treatment
- Clinical signs of skull fracture
- More than one episode of vomiting
- Post-traumatic convulsions
- Focal neurological deficit
- Unable to be followed up at 7 days
- Malignant melanomas
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 15 locations
1
Centre Hospitalier Universitaire d'Angers
Angers, France
Actively Recruiting
2
Hôpital Gabriel-Montpied - CHU de Clermont-Ferrand
Clermont-Ferrand, France
Actively Recruiting
3
Hôpital François Mitterrand - CHU de Dijon
Dijon, France
Actively Recruiting
4
Hôpital Nord - CHU de Grenoble-Alpes
Grenoble, France
Actively Recruiting
5
Hospices Civils de Lyon
Lyon, France
Actively Recruiting
6
Hôpital Lapeyronie - CHU de Montpellier
Montpellier, France
Not Yet Recruiting
7
Hôtel Dieu - CHU de Nantes
Nantes, France
Actively Recruiting
8
Hôpital Pasteur CHU de Nice
Nice, France
Actively Recruiting
9
Hôpital Carémeau - CHU de Nîmes
Nîmes, France
Actively Recruiting
10
AP-HP Nord Lariboisière
Paris, France
Actively Recruiting
11
AP-HP Sorbonne Université, site Pitié-Salpêtrière
Paris, France
Actively Recruiting
12
Hôpital Saint-Joseph
Paris, France
Actively Recruiting
13
Centre Hospitalier Universitaire de Poitiers
Poitiers, France
Actively Recruiting
14
Hôpital Trousseau - CHRU Tours
Tours, France
Actively Recruiting
15
Centre Hospitalier Princesse Grace
Monaco, Monaco
Actively Recruiting
Research Team
Y
Yann-Erick CLAESSENS, MD-PhD
CONTACT
N
Nicolas RIJO, CRA
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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