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

This study is enrolling participants by invitation only.
Sponsor:
Information provided by:
Universal Biosensors Pty Ltd
ClinicalTrials.gov Identifier:
NCT01349712
First received: April 29, 2011
Last updated: May 5, 2011
Last verified: May 2011
History of Changes
  Purpose

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
Blood Coagulation Disorders

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Correlation of Feasibility Batches Using Warfarinised Blood

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Universal Biosensors Pty Ltd:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    To determine the correlation of PT/INR values between an experimental and commercial device.


Estimated Enrollment: 200
Study Start Date: May 2011
Estimated Study Completion Date: November 2011
Estimated Primary Completion Date: November 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts
Coumadin (warfarin)
Subjects are required to be currently receiving coumadin (warfarin) treatment.

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Subjects currently receving coumadin(warfarin) treatment

Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01349712

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

No publications provided

Responsible Party: Richard Ward, Assistant Professor, College of Pharmacy Harding University
ClinicalTrials.gov Identifier: NCT01349712     History of Changes
Other Study ID Numbers: MOB 0158
Study First Received: April 29, 2011
Last Updated: May 5, 2011
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on May 16, 2013