Biomarkers of Traumatic Brain Injury With Tbit System

Brain Injuries, Traumatic Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04107662
• Other study ID #: BDI-TBIT-03
• Status: Not yet recruiting
• Start date: December 1, 2024
• Est. completion date: May 30, 2025

Study information

• Verified date: April 2024
• Source: NanoDx
• Contact: Adelina A Paunescu, PhD
• Phone: 7815268152
• Email: apaunescu[@]medicept.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 740
• Est. completion date: May 30, 2025
• Est. primary completion date: May 30, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Brain Injuries
• Brain Injuries, Traumatic

Intervention

Device:
• Tbit system
Suspected traumatic brain injury with head CT

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
BioDirection Inc

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Tbit™ System User Satisfaction Survey	Tbit™ System User Satisfaction Survey to evaluate the Tbit ease of use by device operators	6 months
Primary	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
Primary	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	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
Secondary	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
Secondary	Overall accuracy of the Tbit™ System	Overall accuracy of the Tbit™ System	within 12 hours from injury on day 0 of ED presentation
Secondary	Safety and adverse event profile	Safety and adverse event profile	6 months