Biomarkers of Traumatic Brain Injury With Tbit System

NCT04107662 | Not Yet Recruiting FDA Device

• 1 other identifier: BDI-TBIT-03
• Study Type: observational
• Target: 740
• Locations: 0 countries
• Sites: N/A

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).

Conditions

Brain Injuries, Traumatic

Keywords

brain; injuries; disease; trauma; nervous system; wounds

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (4)

• 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

  within 12 hours from injury on day 0 of ED presentation

• Overall accuracy of the Tbit™ System

  within 12 hours from injury on day 0 of ED presentation

• Safety and adverse event profile

  6 months

Other Outcomes (1)

• Tbit™ System User Satisfaction Survey

  6 months

Study Arms (1)

Traumatic Brain Injury

Device: Tbit system

Interventions

Tbit system DEVICE

Suspected traumatic brain injury with head CT

Also known as: Head CT scan and blood draw within 12 hours of injury

Traumatic Brain Injury

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• BioDirection Inc: lead

MeSH Terms

Conditions

Brain Injuries, Traumatic; Wounds and Injuries; Disease; Neurologic Manifestations

Condition Hierarchy (Ancestors)

Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms

Study Officials

• Jerika Acosta, BSc

  Medicept Inc.

  STUDY DIRECTOR

Central Study Contacts

Adelina A Paunescu, PhD

CONTACT

7815268152; apaunescu@medicept.com

Travis Jones, BSc

CONTACT

6783207670; tjones@medicept.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 17, 2019
• First Posted: September 27, 2019
• Study Start: December 1, 2024
• Primary Completion: May 30, 2025
• Study Completion: May 30, 2025
• Last Updated: April 5, 2024

Record last verified: 2024-04