Prevention of portal vein thrombosis with anticoagulant therapy in patients with hepatic cirrhosis

Not Applicable

Completed

• Conditions: Advanced stage cirrhosis; Digestive System; Other and unspecified cirrhosis of liver

• Registration Number: ISRCTN32383354
• Lead Sponsor: niversity Hospital of Modena (Azienda Ospedaliero-Universitaria di Modena) (Italy)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-02-21
• Last Update Posted: 20 November 2017

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 66

Inclusion Criteria

1. Age =18 years old
2. Cirrhosis of any etiology
3. Child-Pugh score between B7 to C10
3. No evidence of PVT or spleno-mesenteric thrombosis by ultrasound evaluation and angio-CT, hepatic, renal and coagulative evaluation

Exclusion Criteria

1. Age > 75 years
2. Ascites or porto-systemic encephalopathy (PSE) at time of enrollment or during the previous 3 months
3. History of gastrointestinal bleeding, hepatocellular carcinoma, other intra/extra-hepatic cancers, or thromboembolic disease
4. Ongoing anticoagulation, antiaggregation, or antiphospholipid antibody treatmen
5. Pregnancy or breastfeeding
6. F2 varices with red whale marks or F3 varices unless ligated
7. Platelet count < 10.000/mmc
8. Evidence of paroxysmal nocturnal hemoglobinuria (based on CD 55-CD 59 flow-cytometry); or
9. Human immunodeficiency virus (HIV) infection

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Prevention of portal or mesenteric vein thrombosis

Secondary Outcome Measures

Name	Time	Method
1. Occurrence or recurrence of liver decompensation, defined as development of ascites, PSE, portal hypertensive bleeding, spontaneous bacterial peritonitis, or systemic infection<br>2. Overall and transplant-free survival