Brain Injuries, Traumatic Brain Injury
Conditions
Brief summary
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.
Interventions
DIAGNOSTIC_TESTSingle Group Assignment
Tbit™ System will detect S100B and GFAP concentrations with the blood specimen collected
Sponsors
BioDirection Inc
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
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 * 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Measurement Repeatability | within 12 hours from injury for Tbit and within 30 min from the sample drawn | 1\. Evaluate the repeatability of measurement of S100B and GFAP concentrations in capillary blood using the Tbit™ System at different clinical sites and between-instrument and between-operator components of variance in the intended use environment. |
| Compare Measurements | within 12 hours from injury | 2\. Compare concentrations of S100B and GFAP measured using Tbit™ System in specimens obtained from a fingerstick blood, venous whole blood, serum and plasma in the intended use environment. |
Contacts
Primary ContactLelia A Paunescu, PhD
Backup ContactTravis Jones, BSc
Outcome results
None listed