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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01349712
Recruitment Status : Unknown
Verified May 2011 by Universal Biosensors Pty Ltd.
Recruitment status was:  Enrolling by invitation
First Posted : May 9, 2011
Last Update Posted : May 9, 2011
Information provided by:
Universal Biosensors Pty Ltd

Brief Summary:
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.

Condition or disease
Blood Coagulation Disorders

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
Estimated Enrollment : 200 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Correlation of Feasibility Batches Using Warfarinised Blood
Study Start Date : May 2011
Estimated Primary Completion Date : November 2011
Estimated Study Completion Date : November 2011

Resource links provided by the National Library of Medicine

U.S. FDA Resources

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

Primary Outcome Measures :
  1. 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.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Subjects currently receving coumadin(warfarin) treatment

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:

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01349712

United States, Arkansas
White River Diagnostic Clinic
Batesville, Arkansas, United States, 72501
Sponsors and Collaborators
Universal Biosensors Pty Ltd
Principal Investigator: Richard Ward, Pharm D Harding University

Responsible Party: Richard Ward, Assistant Professor, College of Pharmacy Harding University Identifier: NCT01349712     History of Changes
Other Study ID Numbers: MOB 0158
First Posted: May 9, 2011    Key Record Dates
Last Update Posted: May 9, 2011
Last Verified: May 2011

Additional relevant MeSH terms:
Blood Coagulation Disorders
Hemostatic Disorders
Hematologic Diseases
Vascular Diseases
Cardiovascular Diseases
Hemorrhagic Disorders