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

March 5, 2026 updated by: BioMérieux

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
903

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
To determine VIDAS® TBI sensitivity to exclude the presence of an intracranial lesion
Time Frame: 12 hours post mild brain trauma
12 hours post mild brain trauma
To determine VIDAS® TBI specificity to exclude the presence of an intracranial lesion
Time Frame: 12 hours post mild brain trauma
12 hours post mild brain trauma
To determine VIDAS® TBI Positive Predictive Value to exclude the presence of an intracranial lesion
Time Frame: 12 hours post mild brain trauma
12 hours post mild brain trauma
To determine VIDAS® TBI Negative Predictive Value to exclude the presence of an intracranial lesion
Time Frame: 12 hours post mild brain trauma
12 hours post mild brain trauma
To determine VIDAS® TBI Positive Likelihood Ratio to exclude the presence of an intracranial lesion
Time Frame: 12 hours post mild brain trauma
12 hours post mild brain trauma
To assess VIDAS® TBI Negative Likelihood Ratio to exclude the presence of an intracranial lesion
Time Frame: 12 hours post mild brain trauma
12 hours post mild brain trauma

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
To determine Canadian CT Head Rule sensitivity combined to VIDAS sensitivity to exclude the presence of an intracranial lesion
Time Frame: 12 hours post mild brain trauma
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
Time Frame: 12 hours post mild brain trauma
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
Time Frame: 12 hours post mild brain trauma
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
Time Frame: 12 hours post mild brain trauma
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
Time Frame: 12 hours post mild brain trauma
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
Time Frame: 12 hours post mild brain trauma
12 hours post mild brain trauma
to measure the percentage of CT-scan potentially avoided
Time Frame: 3 months
3 months
To estimate the expected impact of the use of VIDAS® TBI on time to medical decision
Time Frame: 3 months
3 months
To estimate the expected impact of the use of VIDAS® TBI on patient stay in the ED
Time Frame: 3 months
3 months
To estimate the impact of the use of VIDAS® TBI on the time to discharge
Time Frame: 3 months
3 months
To estimate the impact of the use of VIDAS® TBI on the patient's monitoring duration
Time Frame: 3 months
3 months
To estimate the expected impact of the use of VIDAS® TBI on hospitalization decision
Time Frame: 3 months
3 months
To estimate the saving costs when using VIDAS® TBI in comparison with usual clinical sites' care.
Time Frame: 3 months
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.
Time Frame: 3 months
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.
Time Frame: 3 months
3 months

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Time Frame
to measure the percentage of CT-scan potentially avoided
Time Frame: 3 months
3 months
To estimate the biomarkers associated costs compared to the theoretical CT-scan associated costs
Time Frame: 3 months
3 months
To estimate the potentially associated costs saved by VIDAS® TBI use compared to the a theoretical CT-scan associated costs
Time Frame: 3 months
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.
Time Frame: 3 months
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.
Time Frame: 3 months
3 months
To estimate the expected impact of the use of VIDAS® TBI on time to medical decision
Time Frame: 3 months
3 months
To estimate the expected impact of the use of VIDAS® TBI on patient stay in the ED
Time Frame: 3 months
3 months
To estimate the expected impact of the use of VIDAS® TBI on hospitalization decision rate
Time Frame: 3 months
3 months
To estimate the impact of the use of VIDAS® TBI on the time to discharge
Time Frame: 3 months
3 months
To estimate the impact of the use of VIDAS® TBI on the patient's monitoring duration
Time Frame: 3 months
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
BioMérieux

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 16, 2024

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 3, 2025

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 12, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 3, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 3, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 7, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 6, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 5, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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