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NCT06449183 · ClinicalTrials.gov registry record · NA
VIDAS® TBI Real Life Performance in Subjects With Mild Traumatic Brain Injury (mTBI)
A NA study, sponsored by BioMérieux.
- Completed
- Registry status
- NA
- Development phase
- 903
- Enrollment target
NCT06449183 is a NA study that has completed, run by BioMérieux. The registered enrollment target is 903 participants.
The verdict
NCT06449183, a NA study, has completed, sponsored by BioMérieux.
- COMPLETED
- Registry status
- NA
- Development phase
- 903 participants
- Enrollment target
Study 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.
Interventions
- DIAGNOSTIC_TEST VIDAS® TBI Test [GFAP and UCH-L1 assays]
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 903 participants |
| Start Date | 2024-05-16 |
| Est. Completion | 2025-11-12 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06449183
The ClinicalTrials.gov registry entry for NCT06449183 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 903 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is BioMérieux, which has 8 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which VIDAS® TBI Test [GFAP and UCH-L1 assays] is the first listed.
NCT06449183 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT06449183 about?
NCT06449183 is a clinical study titled "VIDAS® TBI Real Life Performance in Subjects With Mild Traumatic Brain Injury (mTBI)". 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 assessme...
What is the current status of trial NCT06449183?
This trial is currently completed. It is a NA study. The enrollment target is 903 participants. The study started on 2024-05-16. Estimated completion is 2025-11-12.
What interventions are being tested in trial NCT06449183?
The interventions under investigation include: VIDAS® TBI Test [GFAP and UCH-L1 assays] (DIAGNOSTIC_TEST).
Who is sponsoring clinical trial NCT06449183?
This trial is sponsored by BioMérieux, which has 8 total clinical trials registered on ClinicalTrials.gov.
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