An evaluation of a coagulation system (Xprecia Stride)
Research type
Research Study
Full title
An evaluation of a point-of-care coagulation system (Xprecia Stride) for utilisation in anticoagulation management.
IRAS ID
182080
Contact name
David Fitzmaurice
Contact email
Duration of Study in the UK
0 years, 5 months, 31 days
Research summary
This is an independent evaluation of the performance and reliability of a new to market point-of-care testing (POC) device called Xprecia Stride. The POC device is intended for use by healthcare professionals to measure the International Normalised Ratio (INR), the test used to calculate the time it takes for blood to clot. Regular monitoring of the INR is necessary in patients receiving warfarin therapy to ensure that the INR is within therapeutic range and avoid complications from over anticoagulation ( e.g bleeding) and under anticoagulation ( e.g thrombosis). Warfarin dose is adjusted based upon the INR result.
The Xprecia Stride POC device is manufactured by Siemens Healthcare Diagnostics Ltd and is CE marked, which means that it meets all the relevant European Medical Device Directives and Standards for POC testing.
Phase 1. Reliability of the new POC device using patient samples
To check the reliability of the new device, we will compare 200 patient INR results from the Xprecia Stride POC device with the results obtained in parallel from another POC device routinely used for INR monitoring and with INR results obtained from a laboratory method. POC INR testing will be performed using two drops of capillary blood from one finger prick. A venous blood sample will be collected following INR testing on the POC devices in 50% participants and sent to the haematology laboratory at University Hospital Birmingham for INR testing.
Phase 2. Healthcare professional perceptions of the new POC device
We are interested to find out what healthcare professionals running warfarin monitoring clinics think about the new POC device, health and safety procedures required to ensure safe use and technical support offered by the manufacturers. To collect this information, healthcare professionals involved in the study will be invited to attend a focus group meeting run by the researchers.REC name
West Midlands - Black Country Research Ethics Committee
REC reference
15/WM/0382
Date of REC Opinion
6 Nov 2015
REC opinion
Favourable Opinion