Study to Test the Accuracy of a Prototype Handheld PT/INR Device
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.
Blood Coagulation Disorders
|Study Design:||Observational Model: Case-Only
Time Perspective: Prospective
|Official Title:||Correlation of Feasibility Batches Using Warfarinised Blood|
- 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.
|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)|
Subjects are required to be currently 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01349712
|United States, Arkansas|
|White River Diagnostic Clinic|
|Batesville, Arkansas, United States, 72501|
|Principal Investigator:||Richard Ward, Pharm D||Harding University|