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 个研究点目标入组 134 人开始时间: 2016年12月9日最近更新: 2023年9月26日

适应症

试验速览

暂无简介。

•- 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

•?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.
•?Pregnancy- lactation

发起方

Fundación para la Investigación Biomédica Hospital Ramón y Cajal