NCT06648837Not yet recruiting
Microvisk Continuous Blood Donation Study
Continuous Blood Donation for the Development of the Microvisk PT/INR
Source: ClinicalTrials.gov · Last updated 21 Nov 2024 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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).
- Status (registry)
- Not yet recruiting
- Study type
- Interventional
- Enrollment
- 2500 (estimated)
- First submitted
- 15 Oct 2024
- Start date
- 13 Jan 2025
- Primary completion date
- 30 Oct 2029
- Lead sponsor
- Microvisk Technologies Ltd
- Diseases
- Atrial fibrillation
- NCT number
- NCT06648837
What you commit to
- Study type: Interventional
- Planned participants: 2500
- From 13 Jan 2025 to the primary completion date, 30 Oct 2029
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Participant has been treated with Unfractionated Heparin, or Low Molecular Weight Heparin, within the last 7 days
- Participant is suspected of intravenous drug use
Other illness
- 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
Age
- Participant is \<18 years of age
Other
- 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
Who the study is looking for
- Currently undergoing Warfarin therapy.
- Over 18 years old
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Oxford Haemophilia and Thrombosis Centre Coordinator of this site? Confirm its status | Oxford | United Kingdom | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.