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Study to Determine the Accuracy of Prothrombin Time of Warfarinised Blood

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01375725
First Posted: June 17, 2011
Last Update Posted: October 12, 2017
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.
Information provided by:
Universal Biosensors Pty Ltd
  Purpose
The purpose of this study is to measure prothrombin time (PT) expressed in International Normalised Ratio (INR) units in persons receiving coumadin (warfarin) treatment on an experimental device and a commercially available device. This study will involve taking a finger-puncture and testing onto a strip and meter system for the experimental and commercially available devices.

Condition
Clotting Disorders

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Mobius PT-INR Accuracy Clinical Study

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: Five 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


Enrollment: 60
Study Start Date: September 2010
Study Completion Date: September 2010
Primary Completion Date: September 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts
Coumadin (warfarin)
Subjects currently receiving coumadin (warfarin) treatment.

  Eligibility

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 receiving coumadin (warfarin) treatment
Criteria

Inclusion Criteria:

  • Are currently taking coumadin (warfarin)
  • Are aged 18 years or older
  • Able and willing to provide informed consent
  • Can understand (read and write) English
  • Required to provide a capillary sample as part of their routine medical check

Exclusion Criteria:

  • Previously participated in this study
  Contacts and Locations
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 ClinicalTrials.gov identifier (NCT number): NCT01375725


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

Responsible Party: Richard Ward, Assistant Professor, College of Pharmacy Harding University
ClinicalTrials.gov Identifier: NCT01375725     History of Changes
Other Study ID Numbers: MOB 0046
First Submitted: June 15, 2011
First Posted: June 17, 2011
Last Update Posted: October 12, 2017
Last Verified: June 2011

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