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Trial record 2 of 229 for:    warfarin AND International

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

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ClinicalTrials.gov Identifier: NCT02355730
Recruitment Status : Unknown
Verified January 2015 by Microvisk Technologies Ltd.
Recruitment status was:  Recruiting
First Posted : February 4, 2015
Last Update Posted : February 4, 2015
Sponsor:
Information provided by (Responsible Party):
Microvisk Technologies Ltd

Brief 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.

Condition or disease Intervention/treatment Phase
Atrial Fibrillation Pulmonary Embolism Deep Vein Thrombosis Procedure: Venepuncture Not Applicable

Detailed Description:

The number of patients receiving anticoagulation therapy with warfarin and other vitamin K antagonists has been rising in recent years. Increasing life expectancy is increasing the proportion of the population having conditions such as Atrial Fibrillation and venous thrombosis, where primary and secondary prevention of thromboembolic complications are best achieved with anticoagulation.

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1560 participants
Intervention Model: Single Group Assignment
Masking: Single (Participant)
Primary Purpose: Diagnostic
Official Title: Blood Donation for the Development and Optimisation of the Second Generation Microvisk International Normalized Ratio (INR) Testing System for the Measurement of Prothrombin Time (PT)/INR in Patients on Warfarin Therapy.
Study Start Date : May 2014
Estimated Primary Completion Date : May 2016
Estimated Study Completion Date : June 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Blood Thinners

Arm Intervention/treatment
Experimental: Warfarin Patients
Single Arm - blood collection by venepuncture in patients undergoing Warfarin Therapy
Procedure: Venepuncture
Venepuncture to collect blood samples from Patients undergoing Warfarin Therapy.




Primary Outcome Measures :
  1. The Primary Outcome will be measured in terms of differences in International Normalised Ratio when the Generation 2 system is tested against the Generation 1 system using the blood samples from the same donors. [ Time Frame: 2 years ]
    The Primary Outcome will be measured in terms of differences in International Normalised Ratio when the Generation 2 system is tested against the Generation 1 system using the blood samples from the same donors. Those differences will be reported in terms of accuracy, precision and sensitivity to interferents.


Secondary Outcome Measures :
  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. [ Time Frame: 2 years ]
    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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Subject is male or female, greater than 18 years of age
  2. Subject is receiving warfarin (or warfarin-like) therapy as part of their clinical care
  3. Subject is informed and has been given ample time and opportunity to think about his/her participation and has given his/her written informed consent

Exclusion Criteria:

  1. Subjects aged <18 years of age
  2. Subjects who are unable to give written consent

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02355730


Contacts
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Contact: Joseph Booth +44 845 956 9900 joebooth@microvisk.com

Locations
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United Kingdom
Royal Liverpool & Broadgreen University Hospital NHS Trust Recruiting
Liverpool, Merseyside, United Kingdom, L7 8XP
Contact: Colin Downey    +44 151 706 4322    Colin.Downey@rlbuht.nhs.uk   
Sponsors and Collaborators
Microvisk Technologies Ltd
Investigators
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Study Chair: Cheng-Hock Toh, Professor Royal Liverpool and Broadgreen University Hospital Trust

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Responsible Party: Microvisk Technologies Ltd
ClinicalTrials.gov Identifier: NCT02355730     History of Changes
Other Study ID Numbers: RDE03
First Posted: February 4, 2015    Key Record Dates
Last Update Posted: February 4, 2015
Last Verified: January 2015
Additional relevant MeSH terms:
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Warfarin
Pulmonary Embolism
Atrial Fibrillation
Thrombosis
Embolism
Venous Thrombosis
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
Embolism and Thrombosis
Vascular Diseases
Lung Diseases
Respiratory Tract Diseases
Anticoagulants