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RecruitingNCT07012291Updated Sep 16, 2025

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

An observational study in Coagulation, sponsored by Perosphere Technologies Inc.. Recruiting at 4 sites in United States. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2025-09-16.

Sponsored by Perosphere Technologies Inc. · Observational

From the registry’s dates

  • Started Jun 2025; still recruiting 1 year 3 months later.
Study type
Observational
Model
Case-control
Time perspective
Prospective
Enrollment
150
Ages
18 Years to 80 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Coagulation

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03

In context

Thrombosis

1,506 studies on the registry are indexed under Thrombosis; 238 are open to participants now.

This study's planned enrollment of 150 is below the median of 213 across 586 observational studies indexed under Thrombosis.

Browse Thrombosis studies →

Lead sponsor

Perosphere Technologies Inc. is the lead sponsor of 2 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

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

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

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.
05

Study design

Observational model
Case-control
Time perspective
Prospective
Enrollment
150 participants (estimated)
Patient registry
No

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.

06

What researchers measure

Primary outcomes

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

    Time frame: 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).

    Time frame: Day 1

07

Study locations

4 of 4 sites recruiting
  • 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
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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 16, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT07012291
Lead sponsor
Perosphere Technologies Inc.
Responsible party
Sponsor
First posted
Jun 10, 2025
Start date
Jun 20, 2025
Primary completion
Jun 1, 2027 (estimated)
Completion
Jun 1, 2027 (estimated)
Last update
Sep 16, 2025

Study contacts

Sasha Bakhru, PhD
Contact
s.bakhru@perospheretech.com
475-218-4601
Dardan Osmani, MS
Contact
d.osmani@perospheretech.com
475-218-4608

Oversight

FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

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