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

NCT06449183 | Completed FDA Device

• 1 other identifier: BM-2023-12
• Study Type: interventional
• Target: 903
• Locations: 1 country
• Sites: 5

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.

Conditions

Mild Traumatic Brain Injury

Keywords

Mild Traumatic Brain Injury; mTBI; TBI; Biomarkers; Automated assays; Ubiquitin Carboxy-terminal Hydrolase-L1 (UCH-L1); Glial Fibrillary Acidic Protein (GFAP); Canadian CT Head Rule; Canadian CT Head Rule (CCHR); Performance; Economic outcomes; Clinical outcomes; CT-Scan; Emergency Department (ED)

Outcome Measures

Primary Outcomes (6)

• 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 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 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 Outcomes (15)

• 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

• 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 Negative Likelihood Ratio combined to VIDAS Negative Likelihood Ration to exclude the presence of an intracranial lesion

  12 hours post mild brain trauma

Study Arms (1)

Subjects with Mild Traumatic Brain injury

EXPERIMENTAL

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.

Diagnostic Test: VIDAS® TBI Test [GFAP and UCH-L1 assays]

Interventions

VIDAS® TBI Test [GFAP and UCH-L1 assays] DIAGNOSTIC_TEST

The VIDAS® TBI (GFAP, UCH-L1) test is composed of two automated assays - VIDAS® TBI (GFAP) and VIDAS® TBI (UCH-L1) - to be used on the VIDAS® family of instruments for the quantitative measurement of Glial 15 Fibrillary Acidic Protein (GFAP) and Ubiquitin C-terminal Hydrolase- L1 (UCH-L1) in human serum using the Enzyme Linked Fluorescent Assay (ELFA) technique. The results of both assays are required to obtain an overall qualitative test interpretation.

Subjects with Mild Traumatic Brain injury

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• BioMérieux: lead

Study Sites (5)

Orlando Health

Orlando, Florida, 32806, United States

Location

Wayne State University

Detroit, Michigan, 48202, United States

Location

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

Washington University

St Louis, Missouri, 63130, United States

Location

University of Rochester

Rochester, New York, 14627, United States

Location

MeSH Terms

Conditions

Brain Concussion; Emergencies

Condition Hierarchy (Ancestors)

Brain Injuries, Traumatic; Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Head Injuries, Closed; Wounds and Injuries; Wounds, Nonpenetrating; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Single Prospective Cohort. Multicentric, International clinical study.

Study Record Dates

• First Submitted: June 3, 2024
• First Posted: June 7, 2024
• Study Start: May 16, 2024
• Primary Completion: September 3, 2025
• Study Completion: November 12, 2025
• Last Updated: March 6, 2026

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (5)