Microvisk Continuous Blood Donation Study
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorMicrovisk Technologies Ltd
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
Currently undergoing Warfarin therapy.
Over 18 years old
Disqualifiers
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)
Trial design
Design model
Single group
Treatments tested in this trial
Venepuncture
Procedure/SurgeryVenepuncture to collect blood samples from Patients undergoing Warfarin Therapy, additional tubes of blood drawn during normal clinical vist.
Collection of relevant information
Other interventionCollect relevant information to ensure potential participant meets all inclusion/exclusion criteria.
Treatment groups
2,500 Participants
are divided into 1 treatment groupGroup A: Warfarin patientsExperimental treatment 2 interventions
Trial outcomes
Primary outcomes
1
Ongoing development of Microvisk Technologies PT/INR products
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.
Time frame
5 yearsSecondary outcomes
1
The Secondary Outcome will be measured in terms of differences in International Normalised Ratio when the Generation 2 system is tested against the International Standard Method using the blood samples from the same donors.
A master batch of test strips will be calibrated against an International Reference Preparation (rTF/09) thromboplastin. The accuracy of the master batch will be verified using patient samples.
Time frame
5 yearsSponsors and contacts
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Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: