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The Perosphere ClotChekâ„¢ 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 ClotChekâ„¢ as a quantitative measurement of the WBCT in patients taking one of the following Direct Oral Anticoagulants (DOACs), rivaroxaban or apixaban.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Whole Blood Clotting Time | Device | 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 | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Differentiating DOAC patients taking rivaroxaban or apixaban from normal control patients, via measurement of their whole blood clotting time. | Day 1 |
| Measure | Description | Time Frame |
|---|---|---|
| To characterize performance of the ClotChekâ„¢ device via whole blood clotting time measurement within clinically relevant patient subgroups (eg renal or hepatic impairment). | Day 1 |
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Inclusion Criteria:
Exclusion Criteria:
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Patients on rivaroxaban or apixaban between the ages of 18 and 80 years old.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Sasha Bakhru, PhD | Contact | 475-218-4601 | s.bakhru@perospheretech.com | |
| Dardan Osmani, MS | Contact | 475-218-4608 | d.osmani@perospheretech.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Perosphere Technologies Inc | Recruiting | Danbury | Connecticut | 06811 | United States |
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| Perosphere Technologies Inc | Recruiting | Rockville | Maryland | 20850 | United States |
|
| Eastern Vascular Associates | Recruiting | Denville | New Jersey | 07834 | United States |
|
| Bassett Research Institute - Center for Clinical Research | Recruiting | Cooperstown | New York | 13326 | United States |
|
| ID | Term |
|---|---|
| D013927 | Thrombosis |
| ID | Term |
|---|---|
| D016769 | Embolism and Thrombosis |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D014914 | Whole Blood Coagulation Time |
| ID | Term |
|---|---|
| D001780 | Blood Coagulation Tests |
| D006403 | Hematologic Tests |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D008919 | Investigative Techniques |
| D001790 | Blood Physiological Phenomena |
| D002943 | Circulatory and Respiratory Physiological Phenomena |
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