Perosphere ClotChek whole-blood clotting test for people on rivaroxaban or apixaban

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

This project will see if the Perosphere ClotChek device can accurately measure whole blood clotting time in adults taking the blood thinners rivaroxaban or apixaban.

Quick facts

• Study type: Observational
• Enrollment: 150 (estimated)
• Ages: 18 Years to 80 Years
• Sex: All
• Sponsor: Perosphere Technologies Inc. (Industry-sponsored)
• Locations: 4 sites (Danbury, Connecticut and 3 other locations)
• Trial ID: NCT07012291 on ClinicalTrials.gov

What this trial studies

The Perosphere ClotChek is a handheld, battery-operated point-of-care instrument that measures whole blood clotting time (WBCT) using freshly drawn, non-citrated blood in disposable cuvettes. This observational protocol enrolls adults aged 18–80 who have been taking rivaroxaban or apixaban for at least one month and collects venous blood samples for WBCT measurement with the device. Collected WBCT values will be characterized as quantitative outputs across the enrolled DOAC-treated population to determine device performance. Study procedures are conducted at Perosphere sites in Connecticut and Maryland and at a collaborating clinical site in New Jersey.

Who should consider this trial

Good fit: Adults aged 18–80 who have been taking rivaroxaban or apixaban regularly for at least one month and who have suitable venous access are ideal candidates.

Not a fit: People with known personal or family clotting disorders, recent gastrointestinal bleeding, unexplained syncope, or other significant hematologic abnormalities are excluded and unlikely to benefit from participation.

Why it matters

Potential benefit: If successful, the device could provide rapid bedside measurement of anticoagulant effect for patients on DOACs, aiding timely clinical decisions.

How similar studies have performed: Some point-of-care coagulation tests and anti-Xa assays have been used to gauge DOAC effects, but handheld quantitative WBCT devices like the ClotChek are relatively novel and not yet widely validated.

Eligibility criteria

Inclusion Criteria:

* 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 Criteria:

* 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.

Where this trial is running

Danbury, Connecticut and 3 other locations

• Perosphere Technologies Inc — Danbury, Connecticut, United States (Recruiting)
• Perosphere Technologies Inc — Rockville, Maryland, United States (Recruiting)
• Eastern Vascular Associates — Denville, New Jersey, United States (Recruiting)
• Bassett Research Institute - Center for Clinical Research — Cooperstown, New York, United States (Recruiting)

Study contacts

• Study coordinator: Sasha Bakhru, PhD

Conditions Coagulation