Evaluation of Precision and Accuracy of INR Measurements in a Point of Care Device (NCT03682419) | Clinical Trial Compass
CompletedNot Applicable
Evaluation of Precision and Accuracy of INR Measurements in a Point of Care Device
United Kingdom420 participantsStarted 2018-09-17
Plain-language summary
Comparison of capillary whole blood INR determined by LumiraDx Instrument to venous plasma INR determined by laboratory reference method (IL ACL ELITE PRO) for method comparison and assessment of accuracy and bias by regression analysis and other analytical methods.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria - VKA Therapy Subjects:
* Persons \>18 years of age
* Willing and able to provide written informed consent and comply with study procedures
* Currently prescribed vitamin K antagonist therapy
* Deemed medically appropriate for study participation by the Investigator
Exclusion Criteria - VKA Therapy Subjects:
* Persons \<18 years of age
* Subject has previously participated in this study
* Subject is within 4 weeks of first prescription of vitamin K antagonist therapy
* Confirmed or suspected pregnancy
* Unwilling or unable to provide written informed consent and comply with study procedures
* Vulnerable populations deemed inappropriate for study by the Investigator
* Deemed medically inappropriate for study by the Investigator (i.e. patients with a known inherited \[e.g. haemophilia or von Willebrand's disease\] or acquired \[e.g. liver cirrhosis\] condition likely to be associated with a coagulopathy; or patients receiving non-VKA anticoagulant medications)
Inclusion Criteria - Non-VKA Therapy Subjects:
* Persons \>18 years of age
* Willing and able to provide written informed consent and comply with study procedures
* Deemed medically appropriate for study participation by the Investigator
Exclusion Criteria - Non-VKA Therapy Subjects:
* Persons \<18 years of age
* Subject has previously participated in this study
* Confirmed or suspected pregnancy
* Unwilling or unable to provide written informed consent and comply with study procedures
* Vulnerab…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Since this trial was specifically comparing the LumiraDx point-of-care INR device against standard lab testing for conditions like mine — such as atrial fibrillation or DVT — how does the accuracy of this kind of fingerstick device hold up compared to the blood draws I'm currently getting at the lab?
2This study has already been completed, so would my doctor have access to the results showing how precise the LumiraDx device was, and would those results change how my INR monitoring could be managed at home or in a clinic?
3For someone on warfarin for a condition like antiphospholipid syndrome or a mechanical heart device, where keeping INR in a very tight range is critical, does my doctor feel a point-of-care device like this would be safe and reliable enough for my specific situation?
4If point-of-care INR testing like what was studied here became part of my care, how would it affect how often I need to come in for monitoring, and are there any limitations I should know about compared to traditional lab testing?
5Are there other completed or ongoing studies comparing point-of-care INR devices that my doctor thinks I should be aware of before we decide whether this kind of testing approach might be right for managing my condition?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
To determine the clinical performance of the LumiraDx instrument