The ex-vivo potency of Edoxaban in patients with cirrhosis
Phase 3
Completed
- Conditions
- end stage liverdiseaseFibrosis1006447710019654
- Registration Number
- NL-OMON45987
- Lead Sponsor
- niversitair Medisch Centrum Groningen
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 16
Inclusion Criteria
- Age over 18 yrs
- Child Pugh A or B cirrhosis
- Informed consent
Exclusion Criteria
* Malignancies
* Renal failure requiring intervention with drugs or dialysis
* Weight under 60 kg
* Active infection
* Use of anticoagulant drugs in the past 10 days
* Use of cyclosporine, dronedarone, erythromycin, or ketoconazole
* Documentation of inherited bleeding disorders
* History of hepatic disease (in the controls)
* History of thrombotic disease
* Recent viral infection (less than two weeks prior to participation)
* Recent (variceal) bleeding or known present varices grade 2-3/3
* Pregnancy
* HIV-infection
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>This study will measure the percentual difference in thrombin generation<br /><br>capacity of plasma taken at baseline versus plasma taken at steady state in<br /><br>patients with cirrhosis and healthy controls. The main endpoint of the study is<br /><br>the difference between the anticoagulant potency (as expressed by percentual<br /><br>decrease in thrombin generation) of edoxaban in patients compared to controls.</p><br>
- Secondary Outcome Measures
Name Time Method <p>This study will also look into the occurence of adverse events and the plasma<br /><br>levels of Edoxaban compared to an anti-Xa assay (calibrated for Edoxaban).<br /><br>Adverse events will be divided into several categories; death, major bleeding,<br /><br>moderate bleeding and mild bleeding events. Major bleeding events are defined<br /><br>as a bleeding at a critical site, a bleeding leading to a loss of 2g/dl of<br /><br>hemoglobin or requiring transfusion of more than two units of blood. Moderate<br /><br>bleeding events do not meet the criteria for major bleeding events but do<br /><br>require medical intervention of transfusion. Mild events do not require<br /><br>intervention or discontinuation of the study drugs.<br /><br>Other end-points: Prothrombin time, activated partial prothrombin time,<br /><br>D-dimer, factor I and II.</p><br>