About this trial
Whole blood clotting time measurements are to collect the clotting time ranges for DOAC-anticoagulated patients and assess their correlation with plasma drug levels (via anti-FXa assay).
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
Other than the condition for which a DOAC was prescribed , 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.
Have a BMI> 40 or weight > 120kg.
Suffer from renal or hepatic insufficiency.
Suffer from any pathology that would contra-indicate in general DOAC medication.
Trial population
Patients treated with rivaroxaban, apixaban, or edoxaban between the ages of 18 and 80 years old. A sufficient number (12 or above) of the patients are above 70 years of age.
Trial design
Cohort
Prospective
Treatments tested in this trial
Whole Blood Clotting Time
Diagnostic testComparator
Treatment groups
Trial outcomes
Primary outcomes
Clotting times of whole blood samples, measured on Perosphere Technologies' PoC Coagulometer devices
Whole Blood Clotting Time
Secondary outcomes
Drug concentrations in collected blood samples as measured through anti-factor Xa (anti-Xa) assay
Drug concentration measurements
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
This trial is not recruiting at the moment. You can still explore other options: