Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
NA
2500 participants
INTERVENTIONAL
2025-01-13
2029-11-01
Brief Summary
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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).
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Detailed Description
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Unpredictable pharmacokinetics, widespread interactions with drugs and food and the narrow therapeutic window make closely monitoring Vitamin K antagonists a necessity. Portable point of care (POC) coagulometers which measure PT from capillary whole blood and provide an INR reading within a few minutes are already widely available throughout North American and Europe. They give comparable results when compared to laboratory based systems are popular with patients and significantly shorten the duration of clinics. In addition, the United Kingdom Department of Health has been encouraging the use of anticoagulation services in Primary Care Trusts the aim being to provide INR monitoring in community clinics and General Practice surgeries relieving pressure on hospital services and reducing inconvenience for patients.
Although coagulometers are now commercially available the Microvisk INR Testing System has been designed to have advantages, particularly in terms of test robustness, user comfort, ease of use and reduction of user error. The present trial has been designed to develop the second generation Microvisk INR Test System; blood samples will also be used to optimise manufacturing processes and verify the quality of Test Strip Lots.
Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
DIAGNOSTIC
NONE
Study Groups
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Warfarin patients
Single Arm - blood collection by venepuncture in patients undergoing Warfarin Therapy
Venepuncture
Venepuncture to collect blood samples from Patients undergoing Warfarin Therapy, additional tubes of blood drawn during normal clinical vist.
Collection of relevant information
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Interventions
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Venepuncture
Venepuncture to collect blood samples from Patients undergoing Warfarin Therapy, additional tubes of blood drawn during normal clinical vist.
Collection of relevant information
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Eligibility Criteria
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Inclusion Criteria
* Over 18 years old
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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Microvisk Technologies Ltd
INDUSTRY
Responsible Party
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Principal Investigators
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Susan Shapiro
Role: PRINCIPAL_INVESTIGATOR
Oxford Haemophilia and Thrombosis Centre Oxford University Hospital NHS Foundation Trust
Locations
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Oxford Haemophilia and Thrombosis Centre
Oxford, Oxfordshire, United Kingdom
Countries
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Central Contacts
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Facility Contacts
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Susan Shapiro
Role: backup
Other Identifiers
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PJP-R-0005
Identifier Type: -
Identifier Source: org_study_id
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