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

Launched by PEROSPHERE TECHNOLOGIES INC. · Jun 6, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a new device called the Perosphere ClotChek™, which is designed to measure how quickly blood clots in patients taking certain blood thinners known as Direct Oral Anticoagulants (DOACs), specifically rivaroxaban or apixaban. The goal is to find out how well this hand-held instrument can perform this test using a small sample of whole blood taken from patients. This could help doctors monitor patients' blood clotting in a more convenient way.

To participate in this study, you need to be between 18 and 80 years old and have been taking your prescribed blood thinner consistently for at least a month. You'll also need to be able to have a blood sample taken. However, there are some conditions that would exclude you from joining, such as certain bleeding disorders or recent serious health issues like gastrointestinal bleeding. If you decide to participate, you will be informed about the study and will need to sign a consent form before any procedures begin. This trial is still in the planning stages and has not started recruiting participants yet.

Gender

ALL

Eligibility criteria

• 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.