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

Universal Biosensors Pty Ltd200 enrolled

Overview

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.

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.

Study Type

OBSERVATIONAL

Enrollment

200

Conditions

Blood Coagulation Disorders

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

White River Diagnostic Clinic

Batesville, Arkansas, United States

Outcomes

Primary Outcomes

PT/INR values from the experimental device will be statistically correlated to results obtained from a commercially available device

To determine the correlation of PT/INR values between an experimental and commercial device.

Time frame: Fives days to collect data and up to two weeks to generate correlation graph

Data from ClinicalTrials.gov

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