Biomarkers of Traumatic Brain Injury With Tbit System

BioDirection

Status: Not yet enrolling

Conditions: Brain Injuries, Traumatic

Treatments: Device: Tbit system

Study type: Observational

Funder types: Industry

Identifiers

NCT04107662

BDI-TBIT-03

Details and patient eligibility

About

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).

Enrollment: 740 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

740 participants in 1 patient group

Traumatic Brain Injury

Treatment:

Device: Tbit system