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Blood Donation From Warfarin Users for the Development of POC INR Monitor

NCT02355730 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 1560

Last updated 2015-02-04

No results posted yet for this study

Summary

This study is to further develop and optimise the design and manufacturing process of a handheld device to monitor and manage Warfarin (blood thinning anticoagulation drug) therapy. The device comprises of a handheld instrument and a disposable test strip and reports how blood coagulation is working in terms of standardised units called International Normalised Ratio (INR). A single drop of fresh whole blood and plasma will be added to the strip and the INR result displayed on the instrument. Blood samples are to be collected from patients attending a hospital based INR clinic who are on Warfarin Therapy. The samples are to be used in a series of experiments in the laboratory to test the Microvisk POC INR Monitors accuracy, precision, stability and robustness.

Conditions

Interventions

PROCEDURE

Venepuncture

Venepuncture to collect blood samples from Patients undergoing Warfarin Therapy.

Sponsors & Collaborators

  • Microvisk Technologies Ltd

    lead INDUSTRY

Principal Investigators

  • Cheng-Hock Toh, Professor · Royal Liverpool and Broadgreen University Hospital Trust

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
SINGLE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-05-31
Primary Completion
2016-05-31
Completion
2016-06-30

Countries

  • United Kingdom

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02355730 on ClinicalTrials.gov