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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
  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:


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
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: 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
Cardiovascular Diseases
Hematologic Diseases
Hemorrhagic Disorders
Vascular Diseases

ClinicalTrials.gov processed this record on November 27, 2014