Microvisk Continuous Blood Donation Study

NCT06648837 | Not Yet Recruiting

• 1 other identifier: PJP-R-0005
• Study Type: interventional
• Target: 2,500
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Pulmonary Embolism (Diagnosis); Deep Vein Thrombosis; Atrial Fibrillation (AF)

Keywords

PT; INR; PT/INR; Warfarin; Vitamin K agonist; POC testing

Outcome Measures

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.

  5 years

Secondary 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.

  5 years

Study Arms (1)

Warfarin patients

EXPERIMENTAL

Single Arm - blood collection by venepuncture in patients undergoing Warfarin Therapy

Procedure: Venepuncture; Other: Collection of relevant information

Interventions

Venepuncture PROCEDURE

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

Warfarin patients

Collection of relevant information OTHER

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

Warfarin patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Currently undergoing Warfarin therapy.
• Over 18 years old

You may not qualify if:

• 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

Sponsors & Collaborators

• Microvisk Technologies Ltd: lead

Study Sites (1)

Oxford Haemophilia and Thrombosis Centre

Oxford, Oxfordshire, OX3 7LD, United Kingdom

Location

MeSH Terms

Conditions

Pulmonary Embolism; Disease; Venous Thrombosis; Atrial Fibrillation

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Embolism; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Thrombosis; Arrhythmias, Cardiac; Heart Diseases

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Susan Shapiro

  Oxford Haemophilia and Thrombosis Centre Oxford University Hospital NHS Foundation Trust

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Matthew Cust

CONTACT

+44 01844338276; matt.cust@microvisk.com

Microvisk Operations

CONTACT

+44 01844338276; operations@microvisk.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 15, 2024
• First Posted: October 18, 2024
• Study Start: January 13, 2025
• Primary Completion (Estimated): October 30, 2029
• Study Completion (Estimated): November 1, 2029
• Last Updated: November 21, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)