Perosphere ClotChek whole-blood clotting test for people on rivaroxaban or apixaban

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

The Perosphere ClotChek is a handheld, battery-operated point-of-care instrument that measures whole blood clotting time (WBCT) using freshly drawn, non-citrated blood in disposable cuvettes. This observational protocol enrolls adults aged 18–80 who have been taking rivaroxaban or apixaban for at least one month and collects venous blood samples for WBCT measurement with the device. Collected WBCT values will be characterized as quantitative outputs across the enrolled DOAC-treated population to determine device performance. Study procedures are conducted at Perosphere sites in Connecticut and Maryland and at a collaborating clinical site in New Jersey.

Why it matters

Who can join: the full rules

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.

Where it's running

• Perosphere Technologies Inc
  Danbury, Connecticut, United States Recruiting
• Perosphere Technologies Inc
  Rockville, Maryland, United States Recruiting
• Eastern Vascular Associates
  Denville, New Jersey, United States Recruiting
• Bassett Research Institute - Center for Clinical Research
  Cooperstown, New York, United States Recruiting

Study contacts

• Study coordinator: Sasha Bakhru, PhD
• Email: s.bakhru@perospheretech.com
• Phone: 475-218-4601

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.