Actively Recruiting
Multi-site Clinical Performance Evaluation of Native Whole Blood Samples of Patients on Direct Oral Anticoagulants With the Perosphere ClotChek173 Coagulometer
Led by Perosphere Technologies Inc. · Updated on 2025-09-16
150
Participants Needed
4
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
This research aims to evaluate the performance of the Perosphere ClotChek173 system, a hand-held, battery-operated blood coagulation device used at the point-of-care, in measuring whole blood clotting time (WBCT) in patients taking direct oral anticoagulants (DOACs) such as rivaroxaban or apixaban. The study focuses on characterizing how well this device can quantitatively assess clotting times in these patients compared to normal controls. Participants provide fresh whole blood samples taken at various times during the day to capture a range of clotting times rather than strict peak or trough measurements. The blood is loaded onto disposable cuvettes without biological reagents for testing with the Perosphere ClotChek173 device. This observational study collects these samples to analyze clotting times and device performance in relevant patient subgroups, including those with renal or hepatic impairments. During the study, participants will undergo venipuncture to provide non-citrated whole blood samples for the clotting time measurements. Researchers will evaluate the device's ability to distinguish between patients on rivaroxaban or apixaban and normal controls. Safety and patient history will be reviewed to ensure eligibility, and clotting times will be assessed on the day of sampling. The study is expected to run until June 2027, with participants involved in a single visit for sample collection and device evaluation.
CONDITIONS
Brief 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 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 blood draw
- Have taken prescribed anticoagulants regularly for at least one month prior to participation
- Be currently on anticoagulant therapy for at least one month
You will not qualify if you...
- Have a personal or family history of clotting disorders or blood abnormalities such as excessive bleeding or thrombocytopenia
- Have a history of unexplained fainting
- Have had peptic ulcers or gastrointestinal bleeding within six months prior to screening
- Smoke more than five cigarettes per day
- If female, have a history of abnormal uterine bleeding unless hysterectomy was performed
- 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
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 1 day
Participants have fresh whole blood samples drawn to measure whole blood clotting time using the Perosphere ClotChek™ device.
1 visit (in-person)
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
D
Dardan Osmani, MS
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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