Biomarkers of Traumatic Brain Injury With Tbit System

Study Overview
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Brief Summary
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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).

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

Conditions
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Brain Injuries, Traumatic

Intervention / Treatment
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* Device: Tbit system


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Traumatic Brain Injury<br> | Device: Tbit system<br>* Suspected traumatic brain injury with head CT<br>* Other names: Head CT scan and blood draw within 12 hours of injury;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cranial CT Intracranial Hemorrhage findings and the binary Tbit™ System (positive/negative) | Cranial CT Intracranial Hemorrhage findings (positive/negative) and the binary Tbit™ System results (positive/negative) of each sample. | within 12 hours from injury on day 0 of ED presentation | 
| Tbit™ System sensitivity and specificity | Tbit™ System sensitivity and specificity relative to the standard-of-care (SOC) | within 12 hours from injury on day 0 of ED presentation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Negative predictive value of the Tbit™ System | Negative predictive value of the Tbit™ System | within 12 hours from injury on day 0 of ED presentation | 
| Positive predictive value of the Tbit™ System | Positive predictive value of the Tbit™ System | within 12 hours from injury on day 0 of ED presentation | 
| Overall accuracy of the Tbit™ System | Overall accuracy of the Tbit™ System | within 12 hours from injury on day 0 of ED presentation | 
| Safety and adverse event profile | Safety and adverse event profile | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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brain, injuries, disease, trauma, nervous system, wounds