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Starting soon Not applicable

Microvisk Continuous Blood Donation Study

NCT06648837 · tracked via the Priya Life Science UK tracker
Sponsor
Microvisk Technologies Ltd
Phase
Not applicable
Started
2025-01-13
Last updated
2024-11-21

Condition(s) studied

Pulmonary Embolism (Diagnosis)Deep Vein ThrombosisAtrial Fibrillation (AF)

Investigational drug(s) / intervention(s)

VenepunctureCollection of relevant information

Venepuncture: Venepuncture to collect blood samples from Patients undergoing Warfarin Therapy, additional tubes of blood drawn during normal clinical vist.

Collection of relevant information: Collect relevant information to ensure potential participant meets all inclusion/exclusion criteria.

Study summary

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).

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * Currently undergoing Warfarin therapy. * Over 18 years old Exclusion Criteria: A participant is not eligible for participation if ANY of the following criteria are met: * Participant is \<18 years of age * Participant is unable to give consent * Participant has been treated with Unfractionated Heparin, or Low Molecular Weight Heparin, within the last 7 days * Participant has, or is suspected of having, Anti-Phospholipid Syndrome (APS) * Participant is pregnant, or has been in the past 12 months * 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 suspected of intravenous drug use

Primary outcome measure(s)

  • Ongoing development of Microvisk Technologies PT/INR products — 5 years
    The Primary Outcome will be measured in terms of differences in International Normalised Ratio when the Generation 2 CoagMax system is tested against the lab benchtop analyser using the blood samples from the same donors. Those differences will be reported in terms of accuracy, precision and sensitivity to interferents.

Trial sites (1)

FacilityCityRegionStatus
Oxford Haemophilia and Thrombosis Centre Oxford Oxfordshire
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06648837 on ClinicalTrials.gov ↗ ← All trials in the UK