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

Shanghai Zhongshan Hospital96 enrolled

Overview

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.

The treatment of cirrhotic patients with PVT (portal vein thrombosis) is clearly recommended in guideline now. Several published studies has confirm the effect and safety of anticoagulation therapy in cirrhotic patients with PVT.The present studies are most observation studies with small sample size and low quality. The investigators need more high-quality research such as randomized controlled trials. This is a Zelen-designed multicenter randomized controlled trial. Patients will randomly enter into two groups:the anticoagulation group or the control group and then the investigator will make sure wether their are fond of the group and make decision by themselves. The recanalization rate and complications will be analyzed

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Portal Vein Thrombosis Liver Cirrhosis

Interventions

Nadroparin Calcium and WarfarinDRUG

Patients will take warfarin started at a dose of 2.5mg/d and with titration of dose to maintain a target INR of 2-3, and during the of perioperative period of Endoscopic treatment changing to use Nadroparin Calcium 4100IU／d，subcutaneous.

Doppler ultrasound and CTDEVICE

all patient will take Doppler ultrasound examination every 3 months ；Abdominal CT will be done every 6 months。

Eligibility

Sex: ALLMin age: 18 YearsMax age: 70 Years

Medical Language ↔ Plain English

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.

Locations (1)

Shanghai Zhongshan Hospital

Shanghai, Shanghai Municipality, China

Outcomes

Primary Outcomes

Recanalization rate of PVT

Patients will receive Doppler ultrasound and CT before enrolled and followed up by Doppler ultrasound every 3 months ,by CT every 6 months after enrolled，untill the end of the study.

Time frame: through study completion，an average of 18 months

Secondary Outcomes

Rebleeding rate

The investigators observe the variceal rebleeding events during the study

Time frame: through study completion，an average of 18 months

Incidence rate of complications

The investigators observe any severe adverse events caused by anticoagulation therapy or the progress of thrombosis.

Time frame: through study completion，an average of 18 months

Central Contacts

Shiyao Chen, Professor

CONTACT

86-13601767310 chen.shiyao@zs-hospital.sh.cn

Data from ClinicalTrials.gov

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