Tbit System Precision and Correlation of Different Blood Samples

Traumatic Brain Injury Clinical Trial

Official title:

A Prospective, Multi-Center, Blood Collection Study to Evaluate TbitTM System Precision and Correlation Between Different Blood Samples Measured With TbitTM System

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04478812
• Other study ID #: BDI-TBIT-04
• Status: Not yet recruiting
• Phase: N/A
• Start date: September 15, 2024
• Est. completion date: November 30, 2024

Study information

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

Clinical Trial Summary

The Tbit™ System will detect S100B and GFAP concentrations with the blood specimen to produce and compare repeated measures from 3 blood samples from 3 fingersticks from one subject and one 1 venous whole blood sample will be collected from the same subject, on 3 different Tbit™ System by 3 different operators.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 81
• Est. completion date: November 30, 2024
• Est. primary completion date: November 30, 2024
• 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

• 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 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
• Traumatic Brain Injury
• Wounds and Injuries

Intervention

Diagnostic Test:
• Single Group Assignment
Tbit™ System will detect S100B and GFAP concentrations with the blood specimen collected

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
BioDirection Inc

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Measurement Repeatability	1. Evaluate the repeatability of measurement of S100B and GFAP concentrations in capillary blood using the Tbit™ System at different clinical sites and between-instrument and between-operator components of variance in the intended use environment.	within 12 hours from injury for Tbit and within 30 min from the sample drawn
Primary	Compare Measurements	2. Compare concentrations of S100B and GFAP measured using Tbit™ System in specimens obtained from a fingerstick blood, venous whole blood, serum and plasma in the intended use environment.	within 12 hours from injury