Blood donation for the development of the Microvisk PT/INR system
Research type
Research Study
Full title
BLOOD DONATION FOR THE DEVELOPMENT AND OPTIMISATION OF THE SECOND GENERATION MICROVISK INR TESTING SYSTEM FOR THE MEASUREMENT OF PT/INR IN PATIENTS ON WARFARIN THERAPY
IRAS ID
227368
Contact name
Lee R Walker
Contact email
Sponsor organisation
Microvisk Technologies Ltd
Clinicaltrials.gov Identifier
N/A, N/A
Duration of Study in the UK
1 years, 11 months, 31 days
Research summary
The overall aim of this research is utilise blood donated from patients on warfarin therapy to aid the development and optimisation of Microvisk’s second generation Prothrombin/International Normalized Ratio (PT/INR) Test System. The donated blood will be used to provide the development team with precision and accuracy information and to validate the devices calibration process.
Microvisk is developing a small hand-held device which will measure PT/INR from a low volume capillary blood sample. The device is intended for use by both healthcare professionals and for self-testing by the patient.
Consenting patients of either sex and all ethnicities over the age of 18 who require PT/INR testing for the purpose of monitoring their oral anticoagulant therapy are eligible to participate in the study.
This blood collection will be conducted at a single site, primarily being the Haemophilia and Thrombosis Centre at Oxford University Hospital. The blood samples will be tested in the centre’s laboratory or may be transported to Microvisk’s own laboratory for evaluation.
Participants attending the centre as part of their routine care will donate an additional tube of blood taken from the same venepuncture as the one used for the collection of blood for local measurement of PT/INR as part of their standard care. In addition the centre will provide PT/INR results from the participant performed, using a clinical laboratory analyser as part of their standard care for the purpose of accuracy estimation of the device. The study will last for a period no longer than 24 months.
REC name
North West - Greater Manchester East Research Ethics Committee
REC reference
17/NW/0443
Date of REC Opinion
21 Aug 2017
REC opinion
Further Information Favourable Opinion