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NCT04107662 | NOT YET RECRUITING | Brain Injuries, Traumatic


Biomarkers of Traumatic Brain Injury With Tbit System
Sponsor:

BioDirection Inc

Brief Summary:

A prospective, multi-center, non-randomized, pivotal study to assess the safety and efficacy of the Tbit™ System to aid in patient evaluation, suspected of traumatic brain injury, as adjunct companion test to radiologic standard of care, Cranial Computerized Tomography (CCT).

Condition or disease

Brain Injuries, Traumatic

Intervention/treatment

Tbit system

Study Type : OBSERVATIONAL
Estimated Enrollment : 740 participants
Official Title : A Prospective, Multi-Center, Non-Randomized Study to Identify Intracranial Hemorrhage by Using an In-Vitro Device, Tbit™ System
Actual Study Start Date : 2024-12-01
Estimated Primary Completion Date : 2025-05-30
Estimated Study Completion Date : 2025-05-30

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
Criteria
Inclusion Criteria
  • * At least 18 years of age
  • * Presents to the Emergency Department with suspected traumatic brain injury
  • * Prescribed a non-contrast CCT as part of routine emergency care within 24 hours from injury
  • * Blood sample collected for Tbit™ System within 12 hours of injury
  • * Willing and able to provide informed consent or obtain consent from legal authorized representative (LAR)
Exclusion Criteria
  • * Suspect of ischemic or hemorrhagic stroke with subsequent incidental trauma based on ED examination
  • * Subject suspect of need of craniotomy for the acute trauma for this event
  • * External signs compatible with a depressed skull fracture based on ED exam
  • * Subject requiring administration of blood transfusion after injury and prior to study blood draw
  • * Subject for whom timing of injury is unable to be estimated within 1 hour of certainty
  • * Subject with a condition precluding entry into the CT scanner
  • * Subject who had neurodegenerative disease or other neurological disorder including dementia, Parkinson's disease, multiple sclerosis, seizures, brain tumors, stroke or TIA within the last 30 days, or history of neurosurgery
  • * Known or suspected to be pregnant
  • * Prisoner or under incarceration
  • * Participating in another clinical research study prior to this study completion

Biomarkers of Traumatic Brain Injury With Tbit System

Location Details

NCT04107662


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