BDI-TBIT-04

About this trial

Last updated a year ago

Study ID

BDI-TBIT-04

Status

Not yet recruiting

Type

Interventional

Phase

N/A

Placebo

Accepting

18+ Years

All

Not accepting

Healthy Volunteers

Trial Timing

Ended 8 months ago

The Tbit™ System will detect S100B and GFAP concentrations with the blood specimen to produce and compare repeated measures from 3 blood samples from 3 fingersticks from one subject and one 1 venous whole blood sample will be collected from the same subject, on 3 different Tbit™ System by 3 different operators.

Inclusion Criteria

- At least 18 years of age

- Presents to the Emergency Department with suspected traumatic brain 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 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

Tbit System Precision and Correlation of Different Blood Samples