Clinical Science Update | New Clinical Evidence for ClotChek™
The information contained herein represents a summary of the peer-reviewed journal article published in Thrombosis and Haemostasis entitled "Clinical Validation of a Point-of-Care Whole Blood Coagulometer in Patients on Factor Xa Inhibitors"
The study evaluated ClotChek Clotting Time (CKCT) in patients receiving Factor Xa (FXa) inhibitors apixaban and rivaroxaban, demonstrating DOAC-sensitivity and strong correlations between the CKCT and the DOAC related anti-FXa drug levels when patients were categorized based on meaningful Medical Decision Limits (MDL), as well as the ability to detect clinically meaningful anticoagulation at both >75 ng/mL and >30 ng/mL MDL thresholds.
"These findings support the potential for ClotChek to address a longstanding unmet clinical need for rapid, bedside assessment of DOAC anticoagulant effect. Results can help inform decision making in time-sensitive patient scenarios such as major bleeding, acute ischemic stroke, trauma, and emergent surgery," said
Importantly, ClotChek provides a pharmacodynamic measurement of a patient's coagulation status in whole blood, without reagents, and demonstrated sensitivity at lower drug concentrations, where knowing how anticoagulated a patient is can be particularly important when making critical decisions.
"Without rapid, objective assessment of anticoagulation status for DOAC patients, clinicians may be forced to make empiric treatment decisions - or even delay or defer potentially time-sensitive interventions," said Dr.
Congratulations to Drs. Bakhru, Connors, Ansell, Giugliano (of the TIMI Study Group) and all the investigators, on this important work, which continues to advance the field of point-of-care coagulation testing.
Learn more about Perosphere Technologies and ClotChek™ at perospheretech.com.
About Perosphere
Perosphere develops point-of-care diagnostics to support informed clinical decision-making for patients receiving anticoagulant therapy or at risk of bleeding. The Perosphere ClotChek™ is a DOAC-sensitive coagulometer designed to rapidly measure whole blood clotting time in 3–8 minutes. Perosphere ClotChek is CE marked in the European Union and is not cleared for use by the FDA in the United States.
Media Contact:
John Friedl | Perosphere, Director of Marketing
[email protected]
+1 (949) 485-0465
Company Contact:
Perosphere
[email protected]
+1 (475) 218-4600
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SOURCE Perosphere Technologies Inc.
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