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

Study Overview
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Brief Summary
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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.

Detailed Description
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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

Official Title
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Effect of Anticoagulation After Endoscopic Therapy in Cirrhotic Patients With Portal Vein Thrombosis：A Zelen-design Multicenter Randomized Controlled Trial

Conditions
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Portal Vein Thrombosis, Liver Cirrhosis

Intervention / Treatment
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* Drug: Nadroparin Calcium and Warfarin
* Device: Doppler ultrasound and CT


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Control.<br>No anticoagulation，just routine follow up. | Device: Doppler ultrasound and CT<br>* all patient will take Doppler ultrasound examination every 3 months ；Abdominal CT will be done every 6 months。<br>|
| Experimental: Anticoagulation<br>Nadroparin Calcium and Warfarin | Drug: Nadroparin Calcium and Warfarin<br>* 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.<br>Device: Doppler ultrasound and CT<br>* all patient will take Doppler ultrasound examination every 3 months ；Abdominal CT will be done every 6 months。<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | through study completion，an average of 18 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rebleeding rate | The investigators observe the variceal rebleeding events during the study | 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. | through study completion，an average of 18 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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anticoagulation