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

Not Applicable

Recruiting

• Conditions: Mild Traumatic Brain Injury
• Interventions: Diagnostic Test: VIDAS® TBI Test [GFAP and UCH-L1 assays]

• Registration Number: NCT06449183
• Lead Sponsor: BioMérieux

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 Timeline

• Study Start: 2024-05-16
• Study First Submitted: 2024-06-03
• Study First Submitted QC: 2024-06-03
• Study First Posted: 2024-06-07
• Status Verified: 2024-07
• Last Update Submitted: 2024-12-20
• Last Update Posted: 2024-12-24
• Primary Completion: 2025-06-16
• Study Completion: 2025-11-16

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 900

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Subjects with Mild Traumatic Brain injury	VIDAS® TBI Test [GFAP and UCH-L1 assays]	Subjects presenting to the ED within 12 hours of suspected mild head trauma and a Glasgow Score of 13-15 undergo to blood collection for VIDAS® TBI \[GFAP, UCH-L1\] testing.

Primary Outcome Measures

Name	Time	Method
To determine VIDAS® TBI Positive Predictive Value to exclude the presence of an intracranial lesion	12 hours post mild brain trauma
To determine VIDAS® TBI Negative Predictive Value to exclude the presence of an intracranial lesion	12 hours post mild brain trauma
To determine VIDAS® TBI sensitivity to exclude the presence of an intracranial lesion	12 hours post mild brain trauma
To determine VIDAS® TBI specificity to exclude the presence of an intracranial lesion	12 hours post mild brain trauma
To determine VIDAS® TBI Positive Likelihood Ratio to exclude the presence of an intracranial lesion	12 hours post mild brain trauma
To assess VIDAS® TBI Negative Likelihood Ratio to exclude the presence of an intracranial lesion	12 hours post mild brain trauma

Secondary Outcome Measures

Name	Time	Method
To determine Canadian CT Head Rule Negative Likelihood Ratio combined to VIDAS Negative Likelihood Ration to exclude the presence of an intracranial lesion	12 hours post mild brain trauma
To determine Canadian CT Head Rule Positive Likelihood Ratio combined to VIDAS Positive Likelihood Ration to exclude the presence of an intracranial lesion	12 hours post mild brain trauma
To estimate the impact of the use of VIDAS® TBI on the time to discharge	3 months
To estimate the expected impact of the use of VIDAS® TBI on patient stay in the ED	3 months
To estimate the expected impact of the use of VIDAS® TBI on hospitalization decision	3 months
To estimate the expected impact of the use of VIDAS® TBI on time to medical decision	3 months
To estimate the impact of the use of VIDAS® TBI on the patient's monitoring duration	3 months
to measure the percentage of CT-scan potentially avoided	3 months
To estimate the saving costs when using VIDAS® TBI in comparison with usual clinical sites' care.	3 months
To estimate the costs of Length of stay in Emergency Department (ED) when using VIDAS® TBI in comparison with usual clinical sites' care.	3 months
To estimate the associated costs of Length of stay in the hospital when using VIDAS® TBI in comparison with usual clinical sites' care.	3 months
To determine Canadian CT Head Rule Negative Predictive Value combined to VIDAS Negative Predictive Value to exclude the presence of an intracranial lesion	12 hours post mild brain trauma
To determine Canadian CT Head Rule specificity combined to VIDAS specificity to exclude the presence of an intracranial lesion	12 hours post mild brain trauma
To determine Canadian CT Head Rule sensitivity combined to VIDAS sensitivity to exclude the presence of an intracranial lesion	12 hours post mild brain trauma
To determine Canadian CT Head Rule Positive Predictive Value combined to VIDAS positive Predictive Value to exclude the presence of an intracranial lesion	12 hours post mild brain trauma

Trial Locations

Locations (5)

Orlando Health; 🇺🇸 Orlando, Florida, United States

Wayne State University; 🇺🇸 Detroit, Michigan, United States

Mayo Clinic; 🇺🇸 Rochester, Minnesota, United States

Washington University; 🇺🇸 Saint Louis, Missouri, United States

University of Rochester; 🇺🇸 Rochester, New York, United States