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
This trial does not accept healthy volunteersQualifiers
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 population
Adult subjects consulting in the emergency department within 12 hours following a mild traumatic brain injury at risk of complications meeting the inclusion and exclusion criteria listed in the protocol.
Trial design
Cohort
Prospective
Treatments tested in this trial
UCH-L1 GFAP
Other interventionmeasurment of UCH-L1 GFAP within 12 hours in adult patients after a mild traumatic brain injury
Treatment groups
Trial outcomes
Primary outcomes
performance of UCH-L1 and GFAP combined to rule out intracranial complication after MTBI
Percentage of intracranial lesion excluded by UCH-L1 and GFAP combined, versus the CT scan, within the first 12 hours following a MTBI
Secondary outcomes
Performance of UCH-L1 and GFAP combined to rule out intracranial bleeding after MTBI
Percentage of intracranial bleeding excluded by UCH-L1 and GFAP alone or combined, versus the CT scan, within the first 12 hours following a MTBI
Performance of UCH-L1 and GFAP combined to rule out intracranial bleeding after MTBI
Percentage of intracranial lesion excluded by UCH-L1 and GFAP alone or combined, versus the CT scan, within the first 12 hours following a MTBI .
Comparation of UCH-L1 and GFAP combined or alone, to S100b protein (PS100b)
Percentage of intracranial complication identified by UCH-L1 and GFAP, alone or in combination, versus PS100b within the first 12 hours following a MTBI .
Predicted impact of using UCH-L1 and GFAP combined
Variation of resource consumption by the use of UCH-L1 and GFAP
Other outcomes
ancillary outcome
Acceptability by a semi-directed interview of a new strategy integrating the use of biomarkers for the management of MTBI by patients and investigators
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
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