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The potency of Edoxaban, a blood thinner, in patients with liverdisease.


- candidate number24544
- NTR NumberNTR5955
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR1-jul-2016
- Secondary IDsMETc 2016/226 METC UMCG
- Public TitleThe potency of Edoxaban, a blood thinner, in patients with liverdisease.
- Scientific TitleThe ex-vivo potency of Edoxaban in patients with cirrhosis
- ACRONYMPOET study
- hypothesis
- Healt Condition(s) or Problem(s) studiedCirrhosis, Anticoagulants
- 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
- mec approval receivedyes
- multicenter trialno
- randomisedno
- groupParallel
- TypeSingle arm
- Studytypeintervention
- planned startdate 1-dec-2016
- planned closingdate31-dec-2018
- Target number of participants32
- InterventionsOverview 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
- Primary outcomethe percentual difference in thrombin generation capacity of plasma taken at baseline versus plasma taken at steady state
- Secondary outcomethe number of adverse events and the plasma levels of Edoxaban compared to an anti-Xa assay (calibrated for Edoxaban).
- TimepointsDay 1, 3 and 7
- Trial web site
- statusplanned
- CONTACT FOR PUBLIC QUERIESMD S. Bos
- CONTACT for SCIENTIFIC QUERIESMD S. Bos
- Sponsor/Initiator University Medical Center Groningen (UMCG)
- Funding
(Source(s) of Monetary or Material Support)
University Medical Center Groningen (UMCG), Daiichi Sankyo
- Publications
- Brief summary
- Main changes (audit trail)
- RECORD1-jul-2016 - 27-nov-2016


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