Assessment of a new blood test for mild traumatic brain injury
Real-life Performance and Added Value of the VIDAS® TBI Blood Test in the Assessment of Mild Traumatic Brain Injury (mTBI), in Subjects with a Glasgow Coma Scale (GCS) Between 13-15
This study is testing a new blood test to see if it can help doctors decide when a CT scan is really needed for adults with mild traumatic brain injuries.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 900 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | BioMérieux Industry-sponsored |
| Drugs / interventions | radiation |
| Locations | 5 sites (Orlando, Florida and 4 other locations) |
| Trial ID | NCT06449183 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effectiveness of the VIDAS® TBI assay, which measures serum biomarkers GFAP and UCH-L1, in optimizing the decision-making process for CT scans in patients with mild traumatic brain injury (mTBI). By providing a rapid and objective assessment, the study aims to reduce unnecessary CT scans and associated radiation exposure while improving patient outcomes. Participants will be adults presenting to the Emergency Department with a GCS score of 13-15 who have a non-contrast CT scan ordered. The study will generate real-world data to support the performance of this new assay in clinical settings.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with a GCS score between 13-15 presenting to the Emergency Department for suspected mild traumatic brain injury.
Not a fit: Patients with non-traumatic neurological disorders, recent neurosurgery, or active cancer will not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to more accurate assessments of mTBI, reducing unnecessary radiation exposure and improving patient management.
How similar studies have performed: Previous studies have shown promise in using serum biomarkers for assessing mTBI, but this specific assay's application in real-world settings is novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Orlando, Florida and 4 other locations
- Orlando Health — Orlando, Florida, United States (Recruiting)
- Wayne State University — Detroit, Michigan, United States (Recruiting)
- Mayo Clinic — Rochester, Minnesota, United States (Recruiting)
- Washington University — Saint Louis, Missouri, United States (Recruiting)
- University of Rochester — Rochester, New York, United States (Recruiting)
Study contacts
- Study coordinator: bioMérieux Medical Affairs
- Email: clinicalstudies@biomerieux.com
- Phone: +33 4 78 87 20 00
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.