CompletedNot Applicable

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

United States903 participantsStarted 2024-05-16

Plain-language summary

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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * 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) Exclusion Criteria: * 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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1This VIDAS TBI test was studied to see how accurately it can rule out intracranial lesions in mild TBI — has the completed data shown it to be sensitive and specific enough that doctors are starting to use it in real clinical settings?
2Since this trial measured the negative predictive value of VIDAS TBI, meaning how confident we can be when the test says there is no brain lesion, how reliable is that 'all clear' result in someone with my type of mild TBI symptoms?
3This study is now completed — have the results been published yet, and is my care team aware of what the data showed about false positives or false negatives with this blood-based test?
4Given that VIDAS TBI is being evaluated as a way to potentially avoid or guide CT scanning, would a test like this change how my doctor would decide whether I need imaging after a mild traumatic brain injury?
5Are there particular patient characteristics — like age, time since injury, or certain symptoms — where this test performed better or worse, and would any of those factors apply to my situation?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

To determine VIDAS® TBI sensitivity to exclude the presence of an intracranial lesion

Timeframe: 12 hours post mild brain trauma

To determine VIDAS® TBI specificity to exclude the presence of an intracranial lesion

Timeframe: 12 hours post mild brain trauma

To determine VIDAS® TBI Positive Predictive Value to exclude the presence of an intracranial lesion

Timeframe: 12 hours post mild brain trauma

To determine VIDAS® TBI Negative Predictive Value to exclude the presence of an intracranial lesion

Timeframe: 12 hours post mild brain trauma

To determine VIDAS® TBI Positive Likelihood Ratio to exclude the presence of an intracranial lesion

Timeframe: 12 hours post mild brain trauma

To assess VIDAS® TBI Negative Likelihood Ratio to exclude the presence of an intracranial lesion

Timeframe: 12 hours post mild brain trauma

Trial details

NCT IDNCT06449183

SponsorBioMérieux

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2025-09-03

View on ClinicalTrials.gov More Mild Traumatic Brain Injury trials

Plain-language summary

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

To determine VIDAS® TBI sensitivity to exclude the presence of an intracranial lesion

Timeframe: 12 hours post mild brain trauma

To determine VIDAS® TBI specificity to exclude the presence of an intracranial lesion

Timeframe: 12 hours post mild brain trauma

To determine VIDAS® TBI Positive Predictive Value to exclude the presence of an intracranial lesion

Timeframe: 12 hours post mild brain trauma

To determine VIDAS® TBI Negative Predictive Value to exclude the presence of an intracranial lesion

Timeframe: 12 hours post mild brain trauma

To determine VIDAS® TBI Positive Likelihood Ratio to exclude the presence of an intracranial lesion

Timeframe: 12 hours post mild brain trauma

To assess VIDAS® TBI Negative Likelihood Ratio to exclude the presence of an intracranial lesion

Timeframe: 12 hours post mild brain trauma