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Clinical Performance Evaluation of Native Whole Blood Samples of Patients on DOACs With the Perosphere ClotChek™
Sponsor: Perosphere Technologies Inc.
Summary
The Perosphere ClotChek™ system consists of a hand-held, battery-operated blood coagulation instrument and disposable test cuvettes for use at the point-of-care (POC). The instrument performs a whole blood clotting time (WBCT) test using freshly drawn, non-citrated whole blood. The purpose of the present study is to characterize the performance of the Perosphere ClotChek™ as a quantitative measurement of the WBCT in patients taking one of the following Direct Oral Anticoagulants (DOACs), rivaroxaban or apixaban.
Official title: Multi-site Clinical Performance Evaluation of Native Whole Blood Samples of Patients on Direct Oral Anticoagulants (DOACs) With the Perosphere ClotChek™ Coagulometer
Key Details
Gender
All
Age Range
18 Years - 80 Years
Study Type
OBSERVATIONAL
Enrollment
150
Start Date
2025-06-20
Completion Date
2027-06-01
Last Updated
2025-09-16
Healthy Volunteers
No
Conditions
Interventions
Whole Blood Clotting Time
Fresh whole blood samples from patients on rivaroxaban or apixaban taken at various times during the day to obtain samples from DOAC patients that represent the entire analytical range to the extent possible, as opposed to a strict "trough/peak" testing schedule.
Whole Blood Clotting Time
Fresh whole blood samples, non-citrated, are drawn and loaded onto a cuvette free of any biological reagents, to obtain a whole blood clotting time value.
Locations (4)
Perosphere Technologies Inc
Danbury, Connecticut, United States
Perosphere Technologies Inc
Rockville, Maryland, United States
Eastern Vascular Associates
Denville, New Jersey, United States
Bassett Research Institute - Center for Clinical Research
Cooperstown, New York, United States