Tbit System Precision and Correlation of Different Blood Samples

BioDirection

Status

Not yet enrolling

Conditions

Brain Injuries

Traumatic Brain Injury

Treatments

Diagnostic Test: Single Group Assignment

Study type

Interventional

Funder types

Industry

Identifiers

NCT04478812

BDI-TBIT-04

Details and patient eligibility

About

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.

Enrollment

81 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
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