Study to Test the Accuracy of a Prototype Handheld PT/INR Device
- Conditions
- Blood Coagulation Disorders
- Registration Number
- NCT01349712
- Lead Sponsor
- Universal Biosensors Pty Ltd
- Brief Summary
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.
- 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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 200
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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method PT/INR values from the experimental device will be statistically correlated to results obtained from a commercially available device Fives 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
Name Time Method
Trial Locations
- Locations (1)
White River Diagnostic Clinic
🇺🇸Batesville, Arkansas, United States