Biomarkers of Traumatic Brain Injury With Tbit System
Not yet recruiting
- Conditions
- Brain Injuries, Traumatic
- Interventions
- Device: Tbit system
- Registration Number
- NCT04107662
- Lead 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).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 740
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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Traumatic Brain Injury Tbit system -
- Primary Outcome Measures
Name Time Method Cranial CT Intracranial Hemorrhage findings and the binary Tbit™ System (positive/negative) within 12 hours from injury on day 0 of ED presentation Cranial CT Intracranial Hemorrhage findings (positive/negative) and the binary Tbit™ System results (positive/negative) of each sample.
Tbit™ System sensitivity and specificity within 12 hours from injury on day 0 of ED presentation Tbit™ System sensitivity and specificity relative to the standard-of-care (SOC)
- Secondary Outcome Measures
Name Time Method Safety and adverse event profile 6 months Safety and adverse event profile
Positive predictive value of the Tbit™ System within 12 hours from injury on day 0 of ED presentation Positive predictive value of the Tbit™ System
Overall accuracy of the Tbit™ System within 12 hours from injury on day 0 of ED presentation Overall accuracy of the Tbit™ System
Negative predictive value of the Tbit™ System within 12 hours from injury on day 0 of ED presentation Negative predictive value of the Tbit™ System