MedPath

Study to Determine the Accuracy of Prothrombin Time of Warfarinised Blood

Completed
Conditions
Clotting Disorders
Registration Number
NCT01375725
Lead Sponsor
Universal Biosensors Pty Ltd
Brief Summary

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.

Detailed Description

Not available

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
60
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

Study & Design

Study Type
OBSERVATIONAL
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
PT/INR values from the experimental device will be statistically correlated to results obtained from a commercially available deviceFive 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

Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (1)

White River Diagnostic Clinic

🇺🇸

Batesville, Arkansas, United States

© Copyright 2025. All Rights Reserved by MedPath