Study to Test the Accuracy of a Prototype Handheld PT/INR Device
Correlation of Feasibility Batches Using Warfarinised Blood
1 other identifier
observational
200
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started May 2011
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 29, 2011
CompletedStudy Start
First participant enrolled
May 1, 2011
CompletedFirst Posted
Study publicly available on registry
May 9, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2011
CompletedMay 9, 2011
May 1, 2011
6 months
April 29, 2011
May 5, 2011
Conditions
Outcome Measures
Primary Outcomes (1)
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.
Fives days to collect data and up to two weeks to generate correlation graph
Study Arms (1)
Coumadin (warfarin)
Subjects are required to be currently receiving coumadin (warfarin) treatment.
Eligibility Criteria
Subjects currently receving coumadin(warfarin) treatment
You may qualify if:
- Currently taking coumadin (warfarin)
- Aged 18 years or older
- Able and willing to provide informed consent
- Can understand (read and write) English
You may not qualify if:
- None
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
White River Diagnostic Clinic
Batesville, Arkansas, 72501, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Richard Ward, Pharm D
Harding University
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
April 29, 2011
First Posted
May 9, 2011
Study Start
May 1, 2011
Primary Completion
November 1, 2011
Study Completion
November 1, 2011
Last Updated
May 9, 2011
Record last verified: 2011-05