A Prospective, Multi-Center, Non-Randomized Study to Identify Intracranial Hemorrhage by Using an In-Vitro Device, Tbit™ System

BioDirection Inc0 sites740 target enrollmentDecember 1, 2024

ConditionsBrain Injuries, Traumatic

Overview

Phase: N/A
Intervention: Not specified
Conditions: Brain Injuries, Traumatic
Sponsor: BioDirection Inc
Enrollment: 740
Primary Endpoint: Cranial CT Intracranial Hemorrhage findings and the binary Tbit™ System (positive/negative)
Status: Not Yet Recruiting
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

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).

Registry

clinicaltrials.gov

Start Date

December 1, 2024

End Date

May 30, 2025

Last Updated

2 years ago

Study Type

Observational

Sex

All

Investigators

Sponsor

BioDirection Inc

Responsible Party

Sponsor

Eligibility 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

Outcomes

Primary Outcomes

Cranial CT Intracranial Hemorrhage findings and the binary Tbit™ System (positive/negative)

Time Frame: 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

Time Frame: within 12 hours from injury on day 0 of ED presentation

Tbit™ System sensitivity and specificity relative to the standard-of-care (SOC)

Secondary Outcomes

Safety and adverse event profile(6 months)
Positive predictive value of the Tbit™ System(within 12 hours from injury on day 0 of ED presentation)
Overall accuracy of the Tbit™ System(within 12 hours from injury on day 0 of ED presentation)
Negative predictive value of the Tbit™ System(within 12 hours from injury on day 0 of ED presentation)