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Study to Determine the Accuracy of Prothrombin Time of Warfarinised Blood

This study has been completed.
Sponsor:
Information provided by:
Universal Biosensors Pty Ltd
ClinicalTrials.gov Identifier:
NCT01375725
First received: June 15, 2011
Last updated: June 16, 2011
Last verified: June 2011
  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

Resource links provided by NLM:


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 ] [ Designated as safety issue: No ]
    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

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 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Richard Ward, Assistant Professor, College of Pharmacy Harding University
ClinicalTrials.gov Identifier: NCT01375725     History of Changes
Other Study ID Numbers: MOB 0046
Study First Received: June 15, 2011
Last Updated: June 16, 2011
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on November 20, 2014