Evaluation of the Perosphere ClotChek12 Device Measuring Whole Blood Clotting Time in Patients Aged 18 to 80 Taking Direct Oral Anticoagulants Rivaroxaban or Apixaban

What this Trial Is About

This research aims to evaluate the performance of the Perosphere ClotChek173 system, a hand-held, battery-operated blood coagulation device used at the point-of-care, in measuring whole blood clotting time WBCT in patients taking direct oral anticoagulants DOACs such as rivaroxaban or apixaban. The study focuses on characterizing how well this device can quantitatively assess clotting times in these patients compared to normal controls. Participants provide fresh whole blood samples taken at various times during the day to capture a range of clotting times rather than strict peak or trough measurements. The blood is loaded onto disposable cuvettes without biological reagents for testing with the Perosphere ClotChek173 device. This observational study collects these samples to analyze clotting times and device performance in relevant patient subgroups, including those with renal or hepatic impairments. During the study, participants will undergo venipuncture to provide non-citrated whole blood samples for the clotting time measurements. Researchers will evaluate the devices ability to distinguish between patients on rivaroxaban or apixaban and normal controls. Safety and patient history will be reviewed to ensure eligibility, and clotting times will be assessed on the day of sampling. The study is expected to run until June 2027, with participants involved in a single visit for sample collection and device evaluation.

Clinical Performance Evaluation of Native Whole Blood Samples of Patients on DOACs With the Perosphere ClotChek™