Coagulation
Conditions
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.
Interventions
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.
Sponsors
Perosphere Technologies Inc.
Study design
Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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
* 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Differentiating DOAC patients taking rivaroxaban or apixaban from normal control patients, via measurement of their whole blood clotting time. | Day 1 |
Secondary
| Measure | Time frame |
|---|---|
| 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 |
Countries
United States
Contacts
Primary ContactSasha Bakhru, PhD
Backup ContactDardan Osmani, MS
Outcome results
None listed