Brain Injuries, Traumatic
Conditions
Keywords
brain, injuries, disease, trauma, nervous system, wounds
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).
Interventions
DEVICETbit system
Suspected traumatic brain injury with head CT
Sponsors
BioDirection Inc
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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) |
| 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Safety and adverse event profile | 6 months | Safety and adverse event profile |
| Overall accuracy of the Tbit™ System | within 12 hours from injury on day 0 of ED presentation | Overall accuracy of the Tbit™ System |
| 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 |
| 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 |
Other
| Measure | Time frame | Description |
|---|---|---|
| Tbit™ System User Satisfaction Survey | 6 months | Tbit™ System User Satisfaction Survey to evaluate the Tbit ease of use by device operators |
Contacts
Primary ContactAdelina A Paunescu, PhD
Backup ContactTravis Jones, BSc
Outcome results
None listed