RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official 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 Glascow Coma Scale (GCS) Between 13-15

Quick Facts

Study Start:2024-05-16
Study Completion:2025-11-16
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06449183

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.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Adult subject ≥ 18 years old
  2. * Subject with a Glasgow Coma Scale (GCS) score between 13-15 on admission
  3. * Subject presenting to the Emergency Department for suspected mild Traumatic Brain Injury
  4. * Subject with a non-contrast head Computed Tomography (CT) scan ordered per the clinical site's care usual care
  5. * Blood sampling possible within 12 hours of injury (1 tube of 4-5 mL of blood)
  6. * Subject expected to stay at least 2 hours in the ED or in a ward
  7. * Subject with signed Informed Consent Form (ICF)
  1. * Time of injury unknown
  2. * Subject with non-traumatic neurological disorders (e.g, dementia, Parkinson's disease, multiple sclerosis, seizure disorder, brain tumors, spontaneous intracranial haematoma)
  3. * Neurosurgery, stroke or transient ischemic attack within the last 30 days
  4. * Subject with an active cancer
  5. * Subject with penetrating head injury
  6. * Special populations, including women with known pregnancy, prisoners, or institutionalized individuals

Contacts and Locations

Study Contact

bioMérieux Medical Affairs
CONTACT
+33 4 78 87 20 00
clinicalstudies@biomerieux.com

Study Locations (Sites)

Orlando Health
Orlando, Florida, 32806
United States
Washington University
Saint Louis, Missouri, 63130
United States
University of Rochester
Rochester, New York, 14627
United States

Collaborators and Investigators

Sponsor: 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 Registration Dates

Study Start Date2024-05-16
Study Completion Date2025-11-16

Study Record Updates

Study Start Date2024-05-16
Study Completion Date2025-11-16

Terms related to this study

Keywords Provided by Researchers

  • 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
  • anadian CT Head Rule (CCHR)
  • Performance
  • Economic outcomes
  • Clinical outcomes
  • CT-Scan
  • Emergency Department (ED)

Additional Relevant MeSH Terms

  • Mild Traumatic Brain Injury