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Completed

NCT Number: NCT06449183

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Orlando Health, Orlando, Florida, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. To determine VIDAS® TBI sensitivity to exclude the presence of an intracranial lesion

    Time frame: 12 hours post mild brain trauma

  2. To determine VIDAS® TBI specificity to exclude the presence of an intracranial lesion

    Time frame: 12 hours post mild brain trauma

  3. To determine VIDAS® TBI Positive Predictive Value to exclude the presence of an intracranial lesion

    Time frame: 12 hours post mild brain trauma

  4. To determine VIDAS® TBI Negative Predictive Value to exclude the presence of an intracranial lesion

    Time frame: 12 hours post mild brain trauma

  5. To determine VIDAS® TBI Positive Likelihood Ratio to exclude the presence of an intracranial lesion

    Time frame: 12 hours post mild brain trauma

  6. To assess VIDAS® TBI Negative Likelihood Ratio to exclude the presence of an intracranial lesion

    Time frame: 12 hours post mild brain trauma

Secondary outcomes

  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

  7. To estimate the impact of the use of VIDAS® TBI on the time to discharge

    Time frame: 3 months

  8. To estimate the expected impact of the use of VIDAS® TBI on patient stay in the ED

    Time frame: 3 months

  9. To estimate the expected impact of the use of VIDAS® TBI on hospitalization decision

    Time frame: 3 months

  10. To estimate the expected impact of the use of VIDAS® TBI on time to medical decision

    Time frame: 3 months

  11. To estimate the impact of the use of VIDAS® TBI on the patient's monitoring duration

    Time frame: 3 months

  12. to measure the percentage of CT-scan potentially avoided

    Time frame: 3 months

  13. To estimate the saving costs when using VIDAS® TBI in comparison with usual clinical sites' care.

    Time frame: 3 months

  14. 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

  15. 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

Sponsors and collaborators

Lead sponsor

BioMérieux

Industry

Registry information

Official study 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 Glasgow Coma Scale (GCS) Between 13-15

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Jun 7, 2024
Registry last updated
Mar 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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