DOAC in Patients With Child B Liver Cirrhosis (CIRROAC)
Liver Cirrhosis
About this trial
This is an interventional other trial for Liver Cirrhosis focused on measuring Cirrhosis, DOAC, Thrombin generation
Eligibility Criteria
Inclusion Criteria: Age 18 years or older Patient already assessed in the previous study (CER-VD 2018-02157) and demonstrating a procoagulant profile Patient with previously diagnosed liver cirrhosis Child B Written informed consent Exclusion Criteria: Pregnancy Oesophageal varices Active ulcer disease of the gastrointestinal tract History of haemorrhagic stroke Severe uncontrolled hypertension Recent brain, spinal or ophthalmic surgery Kidney function inadequate for DOAC treatment Concomitant treatment with anti-platelet drugs Concomitant treatment with anticoagulant drugs (VKA, LMWH, DOAC) Any contraindications for DOAC administration Inability to give informed consent
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Experimental
Experimental
Cirrhotic patient Child B under apixaban
Cirrrhotic patient Child B under edoxaban
Sixteen non-anticoagulated patients with Child B liver cirrhosis and a procoagulant profile will receive a therapeutic dose of apixaban (Eliquis®) for 7 consecutive days. Blood samples will be collected just before and after apixban intake at day 1 and 3. Another blood samples are collected at day 8 and at day 9. In vivo thrombin generation parameters (F1+2, TAT, fibrin monomers, D-dimers), ex vivo thrombin generation parameters [ST Genesia (Drugscreen)], as well as peak and trough apixaban levels will be measured.
Sixteen non-anticoagulated patients with Child B liver cirrhosis and a procoagulant profile will receive a therapeutic dose of edoxaban (Lixiana®) for 7 consecutive days. Blood samples will be collected just before and after edoxaban intake at day 1 and 3. Another blood samples are collected at day 8 and at day 9. In vivo thrombin generation parameters (F1+2, TAT, fibrin monomers, D-dimers), ex vivo thrombin generation parameters [ST Genesia (Drugscreen)], as well as peak and trough edoxaban levels will be measured.