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Collects blood from adults to develop a new warfarin-monitoring test

Donated blood is used to develop a test for people taking warfarin.

Plain-language title generated from the registry record
Registry title: Microvisk Continuous Blood Donation Study

Key facts

Where
Oxford, United KingdomSee the site

Where in United Kingdom

  • Oxford Haemophilia and Thrombosis CentreOxford, United KingdomNo longer taking part

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Trial details

Who runs it
Microvisk Technologies Ltd
Trial code
NCT06648837
Record updated
21 November 2024
Original description
Microvisk Technologies Ltd designs and develops test systems for monitoring the effectiveness of Warfarin and Warfarin-like medications.Read full original descriptionShow less

Continuous Blood Donation for the Development of the Microvisk PT/INR

Microvisk Technologies Ltd designs and develops test systems for monitoring the effectiveness of Warfarin and Warfarin-like medications.

Warfarin and Warfarin-like medications are used to reduce the risk of stroke in people with an irregular heart rhythm (Atrial Fibrillation) or with mechanical heart valve replacements, as well as reducing the risk of recurrent Venous Thromboembolism.

Warfarin dosing needs to be individualized. In order to correctly dose an individual in order to optimize the effectiveness of warfarin, and minimize the risk of bleeding, close monitoring of the degree of anticoagulation is required through regular blood testing. This test is known as PT/INR (Prothrombin Time/International Normalised Ratio). Simply, it is the measure of the amount of time (in seconds) it takes for your blood to clot.

Microvisk Technologies Ltd are developing new anticoagulant test strips for patients on warfarin or warfarin like medications. The blood collected as part of this study will be tested upon Microvisk's second generation Prothrombin/International Normalized Ratio (PT/INR) Test System. The donated blood will be used on ongoing development, validation, verification, and calibration projects. This study is being performed in partnership with the Oxford University Hospital (OUH) and Local Clinical Research Networks (LCRN) Thames Valley Core team, part of National Institute for Health and Care Research (NIHR).

Inclusion: Currently undergoing Warfarin therapy; Over 18 years old.

Exclusion: Participant has been treated with Unfractionated Heparin, or Low Molecular Weight Heparin, within the last 7 days; Participant is suspected of intravenous drug use; Participant has, or is suspected of having, Anti-Phospholipid Syndrome (APS); Participant is known to have HIV/AIDS, is a carrier of Hepatitis A, B or C, has had tuberculosis or a tropical disease; Participant is <18 years of age; A participant is not eligible for participation if ANY of the following criteria are met:; Participant is unable to give consent; Participant is pregnant, or has been in the past 12 months.

ClinicalTrials.gov NCT06648837