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

Description

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

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Study Overview

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Study Details

Study overview

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.

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 Glascow Coma Scale (GCS) Between 13-15

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

Condition
Mild Traumatic Brain Injury
Intervention / Treatment

-

Contacts and Locations

Orlando

Orlando Health, Orlando, Florida, United States, 32806

Saint Louis

Washington University, Saint Louis, Missouri, United States, 63130

Rochester

University of Rochester, Rochester, New York, United States, 14627

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.

For general information about clinical research, read Learn About Studies.

Eligibility 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)
  • * 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

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

BioMérieux,

Study Record Dates

2025-11-16