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

NCT07012291 | Recruiting FDA Device

• 1 other identifier: CP-01-03-001
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 4

Brief 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.

Conditions

Coagulation

Outcome Measures

Primary Outcomes (1)

• Differentiating DOAC patients taking rivaroxaban or apixaban from normal control patients, via measurement of their whole blood clotting time.

  Day 1

Secondary Outcomes (1)

• To characterize performance of the ClotChek™ device via whole blood clotting time measurement within clinically relevant patient subgroups (eg renal or hepatic impairment).

  Day 1

Interventions

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.

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients on rivaroxaban or apixaban between the ages of 18 and 80 years old.

You may qualify if:

• 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 been on their anticoagulant therapy for at least one month.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Perosphere Technologies Inc.: lead

Study Sites (4)

Perosphere Technologies Inc

Danbury, Connecticut, 06811, United States

RECRUITING

Perosphere Technologies Inc

Rockville, Maryland, 20850, United States

RECRUITING

Eastern Vascular Associates

Denville, New Jersey, 07834, United States

RECRUITING

Bassett Research Institute - Center for Clinical Research

Cooperstown, New York, 13326, United States

RECRUITING

MeSH Terms

Conditions

Thrombosis

Interventions

Whole Blood Coagulation Time

Condition Hierarchy (Ancestors)

Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Blood Coagulation Tests; Hematologic Tests; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques; Blood Physiological Phenomena; Circulatory and Respiratory Physiological Phenomena

Central Study Contacts

Sasha Bakhru, PhD

CONTACT

475-218-4601; s.bakhru@perospheretech.com

Dardan Osmani, MS

CONTACT

475-218-4608; d.osmani@perospheretech.com

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 19, 2025
• First Posted: June 10, 2025
• Study Start: June 20, 2025
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): June 1, 2027
• Last Updated: September 16, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (4)