RecruitingNCT07012291

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

Multi-site Clinical Performance Evaluation of Native Whole Blood Samples of Patients on Direct Oral Anticoagulants (DOACs) With the Perosphere ClotChek™ Coagulometer

Sponsor

Perosphere Technologies Inc.

Enrollment

150 participants

Start Date

Jun 20, 2025

Study Type

OBSERVATIONAL

Conditions

Coagulation

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.

Eligibility

Min Age: 18 YearsMax Age: 80 Years

Inclusion Criteria5

Be informed of the nature of the study and provide written informed consent before any study-specific procedures are performed.
Be 18- to 80-years-of-age, inclusive, at time of consent.
Have suitable venous access for at least a single venipuncture.
Eligible patients on anticoagulants must have taken their prescribed anticoagulant regularly at least for one month prior to study participation for inclusion
Eligible patients on anticoagulants must have been on their anticoagulant therapy for at least one month.

Exclusion Criteria6

Have a personal or family history of clotting disorder or hematologic abnormality, such as excessive bleeding, joint hematoma, thrombovascular disease, thrombocytopenia, or any chronic condition requiring treatment with transfusions, other than the condition for which a DOAC was prescribed.
Have a history of unexplained syncope.
Have a history within six months prior to Screening of peptic ulcer or gastrointestinal bleeding (including hematemesis, melena, or rectal bleeding).
Consume more than five cigarettes per day.
If female, have a history of excessive or dysfunctional uterine bleeding (unless the subject had a subsequent hysterectomy).
If female, be pregnant, breastfeeding, or planning to become pregnant during the study.

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Interventions

DEVICEWhole 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.

DEVICEWhole 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.