liver cirrhosis and hepatocellular carcinoma
Conditions
Brief summary
The cumulative incidence of a first venous thromboembolic event within 52 weeks of randomization. • Typical sites: deep vein thrombosis (DVT) and/or pulmonary embolism (PE). • Atypical sites: splanchnic veins (e.g., PVT, mesenteric, splenic, Budd-Chiari), cerebral or retinal veins. All splanchnic events must be confirmed by appropriate imaging techniques and will be classified according to A-VENA criteria to distinguish bland from malignant thrombosis
Detailed description
Secondary: 1) The cumulative incidence of bleeding events will be assessed according to the International Society on Thrombosis and Haemostasis (ISTH) criteria. 2 Liver-related outcomes: Time to first liver decompensation (TTD) is defined as the time from randomization to the first occurrence of any liver events, Exploratory: ROTEM Test
Interventions
Sponsors
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The cumulative incidence of a first venous thromboembolic event within 52 weeks of randomization. • Typical sites: deep vein thrombosis (DVT) and/or pulmonary embolism (PE). • Atypical sites: splanchnic veins (e.g., PVT, mesenteric, splenic, Budd-Chiari), cerebral or retinal veins. All splanchnic events must be confirmed by appropriate imaging techniques and will be classified according to A-VENA criteria to distinguish bland from malignant thrombosis | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary: 1) The cumulative incidence of bleeding events will be assessed according to the International Society on Thrombosis and Haemostasis (ISTH) criteria. 2 Liver-related outcomes: Time to first liver decompensation (TTD) is defined as the time from randomization to the first occurrence of any liver events, Exploratory: ROTEM Test | — |
Outcome results
None listed