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
|Condition or disease||Intervention/treatment||Phase|
|Atrial Fibrillation Pulmonary Embolism Deep Vein Thrombosis||Procedure: Venepuncture||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||1560 participants|
|Intervention Model:||Single Group Assignment|
|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|
Experimental: Warfarin Patients
Single Arm - blood collection by venepuncture in patients undergoing Warfarin Therapy
Venepuncture to collect blood samples from Patients undergoing Warfarin Therapy.
- 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.
- 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.
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
|Contact: Joseph Booth||+44 845 956 firstname.lastname@example.org|
|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|
|Study Chair:||Cheng-Hock Toh, Professor||Royal Liverpool and Broadgreen University Hospital Trust|