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

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

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.

Study Overview

• Status: Completed
• Conditions: Mild Traumatic Brain Injury
• Intervention / Treatment: Diagnostic test: VIDAS® TBI Test [GFAP and UCH-L1 assays]

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 Type: Interventional
• Enrollment (Actual): 903
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Florida
    • Orlando, Florida, United States, 32806
      • Orlando Health
  • Michigan
    • Detroit, Michigan, United States, 48202
      • Wayne State University
  • Minnesota
    • Rochester, Minnesota, United States, 55905
      • Mayo Clinic
  • Missouri
    • St Louis, Missouri, United States, 63130
      • Washington University
  • New York
    • Rochester, New York, United States, 14627
      • University of Rochester

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Subjects with Mild Traumatic Brain injury; 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]; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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 Outcome Measures

Outcome Measure	Time Frame
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 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 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 Positive Likelihood Ratio combined to VIDAS Positive Likelihood Ration 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
to measure the percentage of CT-scan potentially avoided	3 months
To estimate the expected impact of the use of VIDAS® TBI on time to medical decision	3 months
To estimate the expected impact of the use of VIDAS® TBI on patient stay in the ED	3 months
To estimate the impact of the use of VIDAS® TBI on the time to discharge	3 months
To estimate the impact of the use of VIDAS® TBI on the patient's monitoring duration	3 months
To estimate the expected impact of the use of VIDAS® TBI on hospitalization decision	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

Other Outcome Measures

Outcome Measure	Time Frame
to measure the percentage of CT-scan potentially avoided	3 months
To estimate the biomarkers associated costs compared to the theoretical CT-scan associated costs	3 months
To estimate the potentially associated costs saved by VIDAS® TBI use compared to the a theoretical CT-scan associated costs	3 months
To estimate the biomarkers associated costs of Length of stay in Emergency Department (ED) compared to a theoretical CT-scan associated Length of stay in ED.	3 months
To estimate the biomarkers associated costs of Length of stay in the hospital compared to a theoretical CT-scan associated Length of stay at hospital.	3 months
To estimate the expected impact of the use of VIDAS® TBI on time to medical decision	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 rate	3 months
To estimate the impact of the use of VIDAS® TBI on the time to discharge	3 months
To estimate the impact of the use of VIDAS® TBI on the patient's monitoring duration	3 months

Collaborators and Investigators

• Sponsor: BioMérieux

Study record dates

Study Major Dates

• Study Start (Actual): May 16, 2024
• Primary Completion (Actual): September 3, 2025
• Study Completion (Actual): November 12, 2025

Study Registration Dates

• First Submitted: June 3, 2024
• First Submitted That Met QC Criteria: June 3, 2024
• First Posted (Actual): June 7, 2024

Study Record Updates

• Last Update Posted (Actual): March 6, 2026
• Last Update Submitted That Met QC Criteria: March 5, 2026
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Keywords: mTBI; Performance; TBI; Biomarkers; Mild Traumatic Brain Injury; Clinical outcomes; Emergency Department (ED); Economic outcomes; CT-Scan; Automated assays; Ubiquitin Carboxy-terminal Hydrolase-L1 (UCH-L1); Glial Fibrillary Acidic Protein (GFAP); Canadian CT Head Rule; Canadian CT Head Rule (CCHR)
• Additional Relevant MeSH Terms: Brain Injuries, Traumatic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Wounds and Injuries; Pathologic Processes; Disease Attributes; Craniocerebral Trauma; Trauma, Nervous System; Head Injuries, Closed; Wounds, Nonpenetrating; Brain Injuries; Pathological Conditions, Signs and Symptoms; Emergencies; Brain Concussion
• Other Study ID Numbers: BM-2023-12

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No