Study to Determine the Accuracy of Prothrombin Time of Warfarinised Blood

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.

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Key information

Conditions

Clotting Disorders Cardiovascular Diseases Hematologic Diseases Hemic and Lymphatic Diseases Hemorrhagic Disorders Hemostatic Disorders Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

White River Diagnostic Clinic

Batesville, Arkansas, 72501, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

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

Sponsors and collaborators

Lead sponsor

Universal Biosensors Pty Ltd

Industry

Registry information

Official study title

Mobius PT-INR Accuracy Clinical Study

Important dates

Study start: 2010
Primary completion: 2010
Study completion: 2010
First posted: Jun 17, 2011
Registry last updated: Jun 17, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed