VIDAS® TBI Real Life Performance in Subjects With Mild Traumatic Brain Injury (mTBI)

Completed · Not applicable

Conditions studied: Mild Traumatic Brain Injury

In brief

Decision Rules for an initial CT-scan in patients arriving to Emergency Department (ED) and presenting a mild traumatic brain injury could be optimized by the use of an objective parameter easily and rapidly measured. This may be the place for serum biomarkers providing a quick and accurate assessment. BioMérieux has now developed an automated assay for the measurement of serum Glial Fibrillary Acidic Protein (GFAP) and Ubiquitin C-terminal Hydrolase (UCH-L1), the VIDAS® TBI assay to fill out this unmet needs. The goal of the herein study is to generate real-world data and evidences to support the VIDAS® TBI performances.

Key facts

Study ID

NCT06449183

Run by

BioMérieux

People needed

903

Starts

2024-05-16

Expected to finish

2025-11-12

Last updated by the study team

2026-03-06

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Adult subject ≥ 18 years old
• Subject with a Glasgow Coma Scale (GCS) score between 13-15 on admission
• Subject presenting to the Emergency Department for suspected mild Traumatic Brain Injury
• Subject with a non-contrast head Computed Tomography (CT) scan ordered per the clinical site's care usual care
• Blood sampling possible within 12 hours of injury (1 tube of 4-5 mL of blood)
• Subject expected to stay at least 2 hours in the ED or in a ward
• Subject with signed Informed Consent Form (ICF)

You may not qualify if…

• Time of injury unknown
• Subject with non-traumatic neurological disorders (e.g, dementia, Parkinson's disease, multiple sclerosis, seizure disorder, brain tumors, spontaneous intracranial haematoma)
• Neurosurgery, stroke or transient ischemic attack within the last 30 days
• Subject with an active cancer
• Subject with penetrating head injury
• Special populations, including women with known pregnancy, prisoners, or institutionalized individuals

Where it is running

• Orlando Health — Orlando, Florida, United States
• Wayne State University — Detroit, Michigan, United States
• Mayo Clinic — Rochester, Minnesota, United States
• Washington University — St Louis, Missouri, United States
• University of Rochester — Rochester, New York, United States

Full record on ClinicalTrials.gov

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