NCT04032509

A Study of Biomarkers of Mild Traumatic BRAIN Injury

A Prospective Clinical Study of Biomarkers of Mild Traumatic BRAIN Injury

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 1,501 (actual)
• Sponsor: University Hospital, Grenoble · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Patients with mild traumatic brain injury (mTBI) represent a burden of patients admitted to the emergency department. According to the guidelines, a cerebral CT scan is indicated after mTBI according to the specific conditions. However, variability exists regarding the respect of these CT scan indications, and less than 10% of patients will have visible brain lesions on CT scan. Recently, serum Glial Fibrillary Acidic Protein (GFAP) and Ubiquitin C-terminal Hydrolase-L1 (UCH-L1) biomarkers have shown ability to differentiate normal and abnormal CT scan findings after mTBI. These encouraging results prompted us to launch a prospective study using automated and quick measurements of GFAP and UCH-L1 biomarkers to validate these findings.

Conditions

• Mild Traumatic Brain Injury

Interventions

Type	Name	Description
OTHER	2 x 5 mL blood sample	2 x 5 mL blood sample to determine the performance of the automated VIDAS BTI platform in assessing serum concentrations of GFAP and UCH-L1 to rule out the need for a CT-scan after mTBI.

Timeline

• Start date: 2019-08-10
• Primary completion: 2021-06-30
• Completion: 2021-09-28
• First posted: 2019-07-25
• Last updated: 2022-03-02

Locations

16 sites across 2 countries: France, Spain