No registrations found.
ID
Source
Brief title
Health condition
cirrhosis, anticoagulation
Sponsors and support
Unrestricted grant from Daiichi Sankyo
Intervention
Outcome measures
Primary outcome
the percentual difference in thrombin generation capacity of plasma taken at baseline versus plasma taken at steady state
Secondary outcome
the number of adverse events and the plasma levels of Edoxaban compared to an anti-Xa assay (calibrated for Edoxaban).
Study design
Day 1, 3 and 7
Intervention
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.
2. Daily Assesment of vital parameters .
3. Thorough physical examination prior to the first gift of Edoxaban and at day 3 and 7.
4. Blood samples (18 ml, with sodium citrate as anticoagulant) will be taken at set time points:
a. 30 minutes before the first gift of Edoxaban
b. 120 minutes after the first gift
c. 120 minutes after the third gift
d. 120 minutes after the seventh gift
S. Bos
Local code BB31, room Y3.177
Groningen 9713 GZ
The Netherlands
telephone nr: +31503610097
s.bos01@umcg.nl
S. Bos
Local code BB31, room Y3.177
Groningen 9713 GZ
The Netherlands
telephone nr: +31503610097
s.bos01@umcg.nl
Inclusion criteria
• Age > 18 yrs
• Child Pugh A or B cirrhosis
• Informed consent
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
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL5800 |
| NTR-old | NTR5955 |
| Other | METC UMCG : METc 2016/226 |