Tbit System Precision and Correlation of Different Blood Samples

April 3, 2024 updated by: BioDirection Inc

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

81

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Single Group Assignment
Diagnostic test: Single Group Assignment
Tbit™ System will detect S100B and GFAP concentrations with the blood specimen collected

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Measurement Repeatability
Time Frame: within 12 hours from injury for Tbit and within 30 min from the sample drawn
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
Compare Measurements
Time Frame: within 12 hours from injury
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

BioDirection Inc

Investigators

  • Study Director: Jerika Acosta, BSc, Medicept Inc

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

September 15, 2024

Primary Completion (Estimated)

November 30, 2024

Study Completion (Estimated)

November 30, 2024

Study Registration Dates

First Submitted

July 16, 2020

First Submitted That Met QC Criteria

July 16, 2020

First Posted (Actual)

July 21, 2020

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

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BDI-TBIT-04

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

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.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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