Status:
NOT_YET_RECRUITING
Biomarkers of Traumatic Brain Injury With Tbit System
Lead Sponsor:
BioDirection Inc
Conditions:
Brain Injuries, Traumatic
Eligibility:
All Genders
18+ years
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
December 1 2024
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
May 30 2025
Estimated Enrollment :
740 Patients enrolled
Trial Details
Trial ID
NCT04107662
Start Date
December 1 2024
End Date
May 30 2025
Last Update
April 5 2024
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