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

This trial does not accept healthy volunteers

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 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

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • UCH-L1 GFAP

    Other intervention

    measurment of UCH-L1 GFAP within 12 hours in adult patients after a mild traumatic brain injury

Treatment groups

1,500 Participants
are divided into 1 treatment group
Group A: consecutive participants in the 15 centers1 intervention

Trial outcomes

Primary outcomes

1

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

Time frame
during the first 12 hours

Secondary outcomes

1

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

Time frame
during the first 12 hours
2

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 .

Time frame
during the first 12 hours with a focus every 3 hours
3

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 .

Time frame
during the first 12 hours with a focus every 3 hours
4

Predicted impact of using UCH-L1 and GFAP combined

Variation of resource consumption by the use of UCH-L1 and GFAP

Time frame
day 7

Other outcomes

1

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

Time frame
Day 1

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