cirrhosis, anticoagulation
Conditions
Interventions
Overview of planned interventions (this will be performed when the subjects are admitted for their screening programme for liver transplantation):
1. Oral administration of Edoxaban 60 mg once a day.
Sponsors
University Medical Center groningen
Eligibility
Inclusion criteria
Inclusion criteria: • Age > 18 yrs • Child Pugh A or B cirrhosis • Informed consent
Exclusion criteria
Exclusion criteria: • Malignancies • Renal failure requiring intervention with drugs or dialysis • Weight < 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 positivity
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| the percentual difference in thrombin generation capacity of plasma taken at baseline versus plasma taken at steady state | — |
Secondary
| Measure | Time frame |
|---|---|
| the number of adverse events and the plasma levels of Edoxaban compared to an anti-Xa assay (calibrated for Edoxaban). | — |
Contacts
Public ContactS. Bos
Hanzeplein 1
Outcome results
None listed