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

Description

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
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Coagulation

Study Overview

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Study Details

Study overview

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.

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

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

Condition
Coagulation
Intervention / Treatment

-

Contacts and Locations

Danbury

Perosphere Technologies Inc, Danbury, Connecticut, United States, 06811

Rockville

Perosphere Technologies Inc, Rockville, Maryland, United States, 20850

Denville

Eastern Vascular Associates, Denville, New Jersey, United States, 07834

Cooperstown

Bassett Research Institute - Center for Clinical Research, Cooperstown, New York, United States, 13326

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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.
  • * 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.

Ages Eligible for Study

18 Years to 80 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Perosphere Technologies Inc.,

Study Record Dates

2027-06-01