Study to Test the Accuracy of a Prototype Handheld PT/INR Device

May 5, 2011 updated by: Universal Biosensors Pty Ltd

Correlation of Feasibility Batches Using Warfarinised Blood

The purpose of this study is to measure prothrombin time (PT) on an experimental device and a commercially available device on persons receiving coumadin (warfarin)treatment.

Study Overview

Status

Unknown

Conditions

Detailed Description

This study will require participants to have up to 2 finger-punctures taken and sample tested on a strip and meter system for both the experimental and commercially available devices.

Study Type

Observational

Enrollment (Anticipated)

200

Contacts and Locations

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

Study Locations

  • United States
    • Arkansas
      • Batesville, Arkansas, United States, 72501
        • White River Diagnostic Clinic

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

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Subjects currently receving coumadin(warfarin) treatment

Description

Inclusion Criteria:

  • Currently taking coumadin (warfarin)
  • Aged 18 years or older
  • Able and willing to provide informed consent
  • Can understand (read and write) English

Exclusion Criteria:

  • None

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

Cohorts and Interventions

Group / Cohort
Coumadin (warfarin)
Subjects are required to be currently receiving coumadin (warfarin) treatment.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
PT/INR values from the experimental device will be statistically correlated to results obtained from a commercially available device
Time Frame: Fives days to collect data and up to two weeks to generate correlation graph
To determine the correlation of PT/INR values between an experimental and commercial device.
Fives days to collect data and up to two weeks to generate correlation graph

Collaborators and Investigators

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

Sponsor

Universal Biosensors Pty Ltd

Investigators

  • Principal Investigator: Richard Ward, Pharm D, Harding University

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

May 1, 2011

Primary Completion (Anticipated)

November 1, 2011

Study Completion (Anticipated)

November 1, 2011

Study Registration Dates

First Submitted

April 29, 2011

First Submitted That Met QC Criteria

May 5, 2011

First Posted (Estimate)

May 9, 2011

Study Record Updates

Last Update Posted (Estimate)

May 9, 2011

Last Update Submitted That Met QC Criteria

May 5, 2011

Last Verified

May 1, 2011

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MOB 0158

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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