Actively Recruiting
Clinical Performance Evaluation of Native Whole Blood Samples of Patients on DOACs With the Perosphere ClotChek™
Led by Perosphere Technologies Inc. · Updated on 2025-09-16
150
Participants Needed
4
Research Sites
101 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
Clinical Performance Evaluation of Native Whole Blood Samples of Patients on DOACs With the Perosphere ClotChek™
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Provide written informed consent before any study procedures
- Be between 18 and 80 years old at time of consent
- Have suitable venous access for at least one venipuncture
- Have taken prescribed anticoagulants regularly for at least one month prior to participation
- Be on anticoagulant therapy for at least one month
You will not qualify if you...
- Have personal or family history of clotting disorders or blood abnormalities such as excessive bleeding, joint hematoma, thrombovascular disease, thrombocytopenia, or chronic conditions requiring transfusions other than for DOAC treatment
- Have history of unexplained fainting (syncope)
- Have had peptic ulcer or gastrointestinal bleeding within six months before screening
- Smoke more than five cigarettes per day
- If female, have history of excessive or dysfunctional uterine bleeding unless having had a hysterectomy
- If female, be pregnant, breastfeeding, or planning pregnancy during the study
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 4 locations
1
Perosphere Technologies Inc
Danbury, Connecticut, United States, 06811
Actively Recruiting
2
Perosphere Technologies Inc
Rockville, Maryland, United States, 20850
Actively Recruiting
3
Eastern Vascular Associates
Denville, New Jersey, United States, 07834
Actively Recruiting
4
Bassett Research Institute - Center for Clinical Research
Cooperstown, New York, United States, 13326
Actively Recruiting
Research Team
S
Sasha Bakhru, PhD
CONTACT
D
Dardan Osmani, MS
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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