Clinical trial NCT04107662: Biomarkers of Traumatic Brain Injury With Tbit System
Official title: A Prospective, Multi-Center, Non-Randomized Study to Identify Intracranial Hemorrhage by Using an In-Vitro Device, Tbit™ System
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Brain Injuries, Traumatic
Keywords: brain
injuries
disease
trauma
nervous system
wounds
Lead sponsor: NanoDx
Sponsor class: INDUSTRY
First posted: 2019-09-27
Enrollment: 740
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Male and female participants (≥18 years of age) that present to the Emergency Department with suspected non-penetrating blunt trauma within 24 hours from injury and who receive a CT scan as a standard of care.

Brief summary: 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).


Eligibility criteria: 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

Primary outcomes:
measure: Cranial CT Intracranial Hemorrhage findings and the binary Tbit™ System (positive/negative)
timeFrame: within 12 hours from injury on day 0 of ED presentation
measure: Tbit™ System sensitivity and specificity
timeFrame: within 12 hours from injury on day 0 of ED presentation
Secondary outcomes:
measure: Negative predictive value of the Tbit™ System
timeFrame: within 12 hours from injury on day 0 of ED presentation
measure: Positive predictive value of the Tbit™ System
timeFrame: within 12 hours from injury on day 0 of ED presentation
measure: Overall accuracy of the Tbit™ System
timeFrame: within 12 hours from injury on day 0 of ED presentation
measure: Safety and adverse event profile
timeFrame: 6 months
Other outcomes:
measure: Tbit™ System User Satisfaction Survey
timeFrame: 6 months
Locations:
Study officials:
affiliation: Medicept Inc.
name: Jerika Acosta, BSc
role: STUDY_DIRECTOR
References: