EUCTR2016-003240-37-ES
Active, not recruiting
Phase 1
Prospective, multicenter, randomized study to assess the effect of rivaroxaban in the portal vein thrombosis recanalization and the survival in patients with cirrhosis and portal vein thrombosis - TROMBOXABA
Fundación para la Investigación Biomédica Hospital Ramón y Cajal0 sites134 target enrollmentDecember 9, 2016
Conditionsiver cirrhosis and portal vein thrombosisTherapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
DrugsXarelto®
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- iver cirrhosis and portal vein thrombosis
- Sponsor
- Fundación para la Investigación Biomédica Hospital Ramón y Cajal
- Enrollment
- 134
- Status
- Active, not recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •\- Age 18\-75 years.
- •\- Hepatic cirrhosis.
- •\- Thrombosis splenoportal axis: 1\) \>25% on any of the three main vessels (the main trunk of the portal vein, superior mesenteric vein, splenic vein) 2\) Thrombosis affects \> 50% of at least one of the intrahepatic branches.
- •\- Nonterminal Hepatic failure: B7\-C12 state in Child\-Pugh classification.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1\.2 Adults (18\-64 years) yes
- •F.1\.2\.1 Number of subjects for this age range 100
- •F.1\.3 Elderly (\>\=65 years) yes
- •F.1\.3\.1 Number of subjects for this age range 34
Exclusion Criteria
- •?Thrombosis: \<25% of a single vessel of the splenoportal axis.
- •?Patient on the waiting list or evaluation for liver transplantation.
- •?Portal cavernoma (chronic and complete occlusion of the portal vein accompanied by a network of small venous vessels).
- •?Antiplatelet and/or anticoagulant therapy at the time of inclusion.
- •?Platelet count equal or less than 30,000 platelets/mm3\.
- •?Renal failure (creatinine clearance \<15 ml/min).
- •?Severe or terminal liver failure (\= 13 points Child\-Pugh classification).
- •?Active intra or extrahepatic neoplasia.
- •?Clinically significant active bleeding.
- •?Alcohol consumption \= 60 g/day in men and \= 40 g/day in women.
Outcomes
Primary Outcomes
Not specified
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