Study to evaluate the effect of rivaroxaban in patients with advanced liver disease with portal vein thrombosis

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 - TROMBOXABAN

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2016-003240-37-ES

Enrollment

134

Registered

2016-12-09

Start date

2017-02-20

Completion date

Unknown

Last updated

2023-09-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Liver cirrhosis and portal vein thrombosis

Interventions

Trade Name: Xarelto® Pharmaceutical Form: Film-coated tablet INN or Proposed INN: RIVAROXABAN CAS Number: 366789-02-8 Concentration unit: mg milligram(s) Concentration type: equal Concentration number

Eligibility

Sex/Gender

All

Inclusion 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

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. ? Pregnancy- lactation

Design outcomes

Primary

Measure	Time frame
Main Objective: Determine whether anticoagulation with rivaroxaban improved transplant free survival and hospital admissions for hepatic decompensation or significant bleeding complications without progression of thrombosis;Secondary Objective: - To evaluate the efficacy for recanalization of portal vein thrombosis. - To evaluate the efficacy to prevent decompensated cirrhosis complications of portal hypertension (ascites, spontaneous bacterial peritonitis, ruptured variceal haemorrhage or hepatorenal syndrome). - Evaluate the effectiveness in reducing the number of hospital admissions due to decompensated cirrhosis. - Evaluate the safety of withdrawal rate with rivaroxaban anticoagulant therapy due to adverse effects. - Assess the effect on hepatocellular function (Child-Pugh y MELD). - Assess the effect on inflammatory parameters and bacterial translocation.;Primary end point(s): Transplant free survival, without hospital admissions due to liver decompensation or significant bleeding complications, without thrombosis progression;Timepoint(s) of evaluation of this end point: Each visit	—

Measure

Time frame

Main Objective: Determine whether anticoagulation with rivaroxaban improved transplant free survival and hospital admissions for hepatic decompensation or significant bleeding complications without progression of thrombosis;Secondary Objective: - To evaluate the efficacy for recanalization of portal vein thrombosis. - To evaluate the efficacy to prevent decompensated cirrhosis complications of portal hypertension (ascites, spontaneous bacterial peritonitis, ruptured variceal haemorrhage or hepatorenal syndrome). - Evaluate the effectiveness in reducing the number of hospital admissions due to decompensated cirrhosis. - Evaluate the safety of withdrawal rate with rivaroxaban anticoagulant therapy due to adverse effects. - Assess the effect on hepatocellular function (Child-Pugh y MELD). - Assess the effect on inflammatory parameters and bacterial translocation.;Primary end point(s): Transplant free survival, without hospital admissions due to liver decompensation or significant bleeding complications, without thrombosis progression;Timepoint(s) of evaluation of this end point: Each visit

—

Secondary

Measure	Time frame
Secondary end point(s): - Significant bleeding from any cause. - Cirrhosis complications requiring hospital admission (ascites, hemorrhage, Hepatic encephalopathy grade II or higher). - Progression of portal thrombosis.;Timepoint(s) of evaluation of this end point: Each visit	—

Countries

Spain

Contacts

Public ContactMarta del Álamo

Spanish Clinical Research Network

martadelalamo.hrc@gmail.com+34913368825

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026