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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorCentre Hospitalier Princesse Grace

About this trial

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

Qualifiers

Traumatic brain injury defined by

Impact on the skull or the face AND OR

Acceleration / deceleration

Glasgow Coma Scal 13, 14 or 15

Disqualifiers

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

Trial design

Treatments tested in this trial

  • UCH-L1 GFAP

Treatment groups

1,500 Participants
are divided into 1 treatment group

Sponsors and collaborators

Centre Hospitalier Princesse Grace

Lead sponsor

BioMérieux

Collaborator

Assistance Publique - Hôpitaux de Paris

Collaborator

University Hospital, Clermont-Ferrand

Collaborator

Hospices Civils de Lyon

Collaborator

Poitiers University Hospital

Collaborator

University Hospital, Angers

Collaborator

Centre Hospitalier Universitaire de Nīmes

Collaborator

Centre Hospitalier Universitaire de Nice

Collaborator

Nantes University Hospital

Collaborator

University Hospital, Montpellier

Collaborator

Centre Hospitalier Universitaire Dijon

Collaborator

University Hospital, Grenoble

Collaborator

Fondation Hôpital Saint-Joseph

Collaborator

CHU de Tours

Collaborator