The Perosphere Technologies' PoC Coagulometer measures clotting times of fresh whole blood samples. Clotting is initiated by glass surface activation and terminates on optical detection of fibrin assembly, the final step in the coagulation cascade. Since activation occurs at the top of the intrinsic pathway and detection occurs at the bottom of the final common pathway, the Perosphere Technologies' PoC Coagulometer has shown sensitivity to a broad range of drugs and reagents that affect blood clotting processes, including the Direct Oral Anticoagulants, DOACs (e.g. rivaroxaban, apixaban, and edoxaban), as well as the heparins (e.g. enoxaparin, a low molecular weight heparin, and unfractionated heparin). The purpose of the present study is to characterize the performance of the PoC Coagulometer measuring Clotting Time Controls, as well as fresh whole blood from both healthy volunteers and DOAC patients at three field testing sites.
Study Type
OBSERVATIONAL
Enrollment
300
peak and trough coagulation measurements of patients treated with Xarelto, Eliquis, or Lixiana and coagulation measurements of healthy proband blood spiked with eiter Xarelto, Eliquis or Lixiana.
Perosphere Technologies Inc.
Danbury, Connecticut, United States
RECRUITINGPerosphere Technologies Inc.
Boynton Beach, Florida, United States
RECRUITINGPerosphere Technologies Inc.
Rockville, Maryland, United States
RECRUITINGPerosphere Technologies Inc.
White Plains, New York, United States
RECRUITINGPfuetzner Science and Health Institute GmbH
Mainz, Rhineland-Palatinate, Germany
RECRUITINGClotting times of whole blood samples, measured on Perosphere Technologies' PoC Coagulometer devices
Clotting times measured on Perosphere Technologies´ PoC of patients on Xarelto, Eliquis or Lixiana
Time frame: During the first/single study visit
Drug concentrations in collected blood samples as measured through anti-factor Xa (anti-Xa) assay
Drug concentrations in collected blood samples as measured through anti-factor Xa (anti-Xa) assay
Time frame: During the first/single study visit
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