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
Algemeen / deelnemers
S. Bos
Local code BB31, room Y3.177
Groningen 9713 GZ
The Netherlands
telephone nr: +31503610097
s.bos01@umcg.nl
Wetenschappers
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
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Andere (mogelijk minder actuele) registraties in dit register
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In overige registers
| Register | ID |
|---|---|
| NTR-new | NL5800 |
| NTR-old | NTR5955 |
| Ander register | METC UMCG : METc 2016/226 |