Microvisk Continuous Blood Donation Study

Condition(s) studied

Investigational drug(s) / intervention(s)

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

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)

Other trials for the same condition