Evaluation of the CoaguChek XS PT Masterlot 14
Research type
Research Study
Full title
Post Launch Study Evaluation of the CoaguChek XS PT Masterlot 14 CIM RD004722
IRAS ID
263236
Contact name
Mark Grey
Contact email
Sponsor organisation
Roche
Duration of Study in the UK
0 years, 5 months, 13 days
Research summary
This is a non-interventional, single center study. In this study we evaluate the CoaguChek XS PT masterlot 14. The CoaguChek XS system is a portable device for the monitoring of oral anticoagulation therapy either by patients or by health care professionals. The device uses specific test strips. The current lot of prothrombin test strips produced by Roche Diagnostics is called “PT masterlot 14”.
topics:
1. To generate data from patient samples to establish a new calibration curve for masterlot 14
2. To evaluate the comparability of masterlot 14 to other test methods.
(methods: Innovin and Recombiplastin test methods and the tilt tube reference method)Results are used to establish a new calibration curve for PT Masterlot 14.
Method comparison results are intended to be published as a guidance for health care professionals and patients.The study is split in two parts, a mandatory main trial and an optional routine-like testing phase.
First part – main trial
• For the main trial 205 subjects will be recruited. Subjects trial will sign an informed consent before any blood is drawn specifically for this study. Once consent has been given, a single venous blood draw of 7 mL will be taken from subjects.
• Parts of the blood sample will be used for testing of the prothrombin time at the study site, using CoaguChek XS PT and the local lab method called Recombiplastin.
• Other parts of the sample will be shipped to the sponsor and will be tested using the Innovin and the tilt tube method.Second part – routine-like testing phase
• Leftover samples from the daily routine will be used for local testing with CoaguChek XS PT and Recombiplastin at the study site.
• No additional blood draw is required, no samples will be transferred to the sponsor.
• Only data collected is the routine INR determination.REC name
South Central - Berkshire Research Ethics Committee
REC reference
19/SC/0196
Date of REC Opinion
9 Apr 2019
REC opinion
Favourable Opinion