Ignite Creation Date:
2024-06-16 @ 11:50 AM
Last Modification Date:
2024-10-26 @ 3:31 PM
Study NCT ID:
NCT06449183
Status:
RECRUITING
Last Update Posted:
2024-06-07
First Post:
2024-06-03
Brief Title:
VIDAS TBI Real Life Performance in Subjects with Mild Traumatic Brain Injury mTBI
Sponsor:
BioMérieux
Organization:
BioMérieux
Study Overview
Official Title:
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 Glascow Coma Scale GCS Between 13-15
Status:
RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
Detailed Description:
The assessment of severity of TBI patients is based on the Glasgow Coma Scale GCS and the initial management in the ED includes performing a non-contrast brain Computed Tomography CT scan if the patient meets specific conditions To date real world data show that EDs would actually not follow guideline recommendations and a substantial CT overuse is observed Management strategies are becoming more and more focused on selective CT use to effectively manage health care resources Efforts have been made to optimize the indications for brain CT scan after mTBI Although brain CT scan plays a central role after mTBI there is an unmet clinical need for an objective tool to optimize indications for CT scan reduce patient radiation exposure and possibly predict patient outcome Clinical Decision Rules for an initial CT-scan 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None