ID
Bron
Verkorte titel
Aandoening
cirrhosis, anticoagulation
Ondersteuning
Unrestricted grant from Daiichi Sankyo
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
the percentual difference in thrombin generation capacity of plasma taken at baseline versus plasma taken at steady state
Onderzoeksopzet
Day 1, 3 and 7
Onderzoeksproduct en/of interventie
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
Publiek
S. Bos
Local code BB31, room Y3.177
Groningen 9713 GZ
The Netherlands
telephone nr: +31503610097
s.bos01@umcg.nl
Wetenschappelijk
S. Bos
Local code BB31, room Y3.177
Groningen 9713 GZ
The Netherlands
telephone nr: +31503610097
s.bos01@umcg.nl
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
• Age > 18 yrs
• Child Pugh A or B cirrhosis
• Informed consent
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
• 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
Opzet
Deelname
Opgevolgd door onderstaande (mogelijk meer actuele) registratie
Geen registraties gevonden.
Andere (mogelijk minder actuele) registraties in dit register
Geen registraties gevonden.
In overige registers
| Register | ID |
|---|---|
| NTR-new | NL5800 |
| NTR-old | NTR5955 |
| Ander register | METC UMCG : METc 2016/226 |