The Effect of Anticoagulation in Cirrhotic Patients With Portal Vein Thrombosis：A Multicenter RCT

• Status: Unknown status
• Trial end date: 2018-09-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to determine the effect and safety of anticoagulation after endoscopic therapy in cirrhotic patients with portal vein thrombosis and to explore its effect on long-term rebleeding rate and mortality.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Shanghai Zhongshan Hospital
• Collaborators: Eastern Hepatobiliary Surgery Hospital; Gongli Hospital of Shanghai Pudong District; Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine; Shanghai Public Health Clinical Center; Shanghai Pudong New Area Gongli Hospital; ShuGuang Hospital; Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
• Treatments: Calcium; Calcium, Dietary; Nadroparin; Warfarin

Criteria

Inclusion Criteria:

• Age between 18-70 years old;

• A clinical, radiological or histologic diagnosis of Liver cirrhosis and portal hypertension;

• Diagnosed of Portal vein thrombosis;

• Capable of understanding the purpose and risks of the study and informed consent to participate in the study;

• Have undergone endoscopy to prevent variceal rebleeding.

Exclusion Criteria:

• Age <18 or >70 years;

• Portal vein thrombosis diagnosed before 6 months;

• Patients with signs of acute PVT such as fever，abdominal pain or intestinal obstruction，who should be treated immediately;

• Pregnant or nursing;

• Hepatocellular carcinoma or other cancer;

• Severe cardiopulmonary diseases or concomitant renal insufficiency;

• cavernous transformation of the portal vein;

• Contradictions to endoscopy;

• Contradictions to anticoagulation,such as:allergy to LMWH or warfarin, severe uncontrolled hypertension, history of hemorrhagic cerebral vascular accident, recent peptic ulcer disease, bacterial endocarditis, ulcerative colitis，sustained platelet count < 50 x10^9/L);

• Taking immunosuppressive agent;

• Coagulation disorders other than the liver disease related;

• Variceal bleeding failed to control.