Biomarkers of Traumatic Brain Injury With Tbit System

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

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).

Study Overview

• Status: Not yet recruiting
• Conditions: Brain Injuries, Traumatic
• Intervention / Treatment: Device: Tbit system

• Study Type: Observational
• Enrollment (Estimated): 740

Contacts and Locations

• Study Contact: Name: Adelina A Paunescu, PhD; Phone Number: 7815268152; Email: apaunescu@medicept.com
• Study Contact Backup: Name: Travis Jones, BSc; Phone Number: 6783207670; Email: tjones@medicept.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• 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.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Traumatic Brain Injury	Device: Tbit system; Suspected traumatic brain injury with head CT; Other Names: Head CT scan and blood draw within 12 hours of injury

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Tbit™ System User Satisfaction Survey	Tbit™ System User Satisfaction Survey to evaluate the Tbit ease of use by device operators	6 months

Collaborators and Investigators

• Sponsor: BioDirection Inc
• Investigators: Study Director: Jerika Acosta, BSc, Medicept Inc

Study record dates

Study Major Dates

• Study Start (Estimated): December 1, 2024
• Primary Completion (Estimated): May 30, 2025
• Study Completion (Estimated): May 30, 2025

Study Registration Dates

• First Submitted: September 17, 2019
• First Submitted That Met QC Criteria: September 25, 2019
• First Posted (Actual): September 27, 2019

Study Record Updates

• Last Update Posted (Actual): April 5, 2024
• Last Update Submitted That Met QC Criteria: April 3, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: trauma; brain; nervous system; wounds; disease; injuries
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Wounds and Injuries; Craniocerebral Trauma; Trauma, Nervous System; Brain Injuries; Brain Injuries, Traumatic
• Other Study ID Numbers: BDI-TBIT-03

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No