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

Status: Recruiting
Location: See all (15) locations...
Intervention Type: Other
Study Type: Observational
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
France
Centre Hospitalier Universitaire d'Angers
RECRUITING
Angers
Hôpital Gabriel-Montpied - CHU de Clermont-Ferrand
RECRUITING
Clermont-ferrand
Hôpital François Mitterrand - CHU de Dijon
RECRUITING
Dijon
Hôpital Nord - CHU de Grenoble-Alpes
RECRUITING
Grenoble
Hospices Civils de Lyon
RECRUITING
Lyon
Hôpital Lapeyronie - CHU de Montpellier
NOT_YET_RECRUITING
Montpellier
Hôtel Dieu - CHU de Nantes
RECRUITING
Nantes
Hôpital Pasteur CHU de Nice
RECRUITING
Nice
Hôpital Carémeau - CHU de Nîmes
RECRUITING
Nîmes
AP-HP Nord Lariboisière
RECRUITING
Paris
AP-HP Sorbonne Université, site Pitié-Salpêtrière
RECRUITING
Paris
Hôpital Saint-Joseph
RECRUITING
Paris
Centre Hospitalier Universitaire de Poitiers
RECRUITING
Poitiers
Hôpital Trousseau - CHRU Tours
RECRUITING
Tours
Monaco
Centre Hospitalier Princesse Grace
RECRUITING
Monaco
Contact Information
Primary
Yann-Erick CLAESSENS, MD-PhD
yann-erick.claessens@chpg.mc
97 98 99 00
Backup
Nicolas RIJO, CRA
recherche.clinique@chpg.mc
97 98 99 00
Time Frame
Start Date: 2024-04-19
Estimated Completion Date: 2026-03-30
Participants
Target number of participants: 1500
Treatments
consecutive participants in the 15 centers
adult patients with mild traumatic brain injury admitted within 12 hours after the trauma. No interventions, observational study
Related Therapeutic Areas
Sponsors
Collaborators: University Hospital, Montpellier, Hospices Civils de Lyon, Centre Hospitalier Universitaire de Nīmes, Nantes University Hospital, Centre Hospitalier Universitaire Dijon, University Hospital, Clermont-Ferrand, Poitiers University Hospital, University Hospital, Angers, CHU de Tours, Assistance Publique - Hôpitaux de Paris, University Hospital, Grenoble, Centre Hospitalier Universitaire de Nice, BioMérieux, Fondation Hôpital Saint-Joseph
Leads: Centre Hospitalier Princesse Grace

This content was sourced from clinicaltrials.gov