The Effect of Rifaximin on Portal Vein Thrombosis

Study Overview
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Brief Summary
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The aim of this study is to evaluate the efficacy of rifaximin in the treatment of portal vein thrombosis in cirrhotic patients

Detailed Description
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Portal vein thrombosis is not an uncommon complication in cirrhotic portal hypertension, which lead to a poor prognosis in endoscopic management of variceal bleeding. Evidence indicated that enoxaparin prevented PVT and liver decompensation via decreased rates of bacterial infections and lowered the potent inflammatory mediators such as interleukin-6. Rifaximin is a broad-spectrum antibiotic that exerts endotoxin-lowering and anti-inflammatory effects.

Official Title
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The Effect of Rifaximin on Portal Vein Thrombosis in Cirrhotic Patients

Conditions
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Cirrhosis, Portal Vein Thrombosis

Intervention / Treatment
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* Drug: Rifaximin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 18 y.o. ≤age≤75 y.o Cirrhotic patients had CTA confirmed portal vein trombosis D-dimer no more than five times the normal upper limit Exclusion Criteria: age <18 y.o. or age > 75 y.o. had portal cavernoma received anticoagulation treatment in the past 6 months splenectomy Known infection after endoscopic treatment (Fever, microbial cultures positive, et al.) Massive ascites or combined with other high risk factor that require prophylaxis use of antibiotics. Acute variceal bleeding within 5 days. Use of other antibiotics in the past 2 weeks Acute portal vein thrombosis

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Rifaximin treatment group<br>Rifaximin 400mg bid for 8 weeks | Drug: Rifaximin<br>* 400mg bid for 8 weeks<br>* Other names: XIFAXAN;|
| No Intervention: The control group<br> | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes of portal vein thrombosis | The changes of portal vein thrombosis in 8 weeks (include main portal vein, left and/or right portal vein, superior mesenteric vein, et al) | 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes of portal vein thrombosis | The changes of portal vein thrombosis in 8 weeks (include main portal vein, left and/or right portal vein, superior mesenteric vein, et al) | 6 months | 
| All clinical events | All clinical events were defined as occurrence rebreeding, ascitic fluid infection, hepatorenal syndrome, hepatopulmonary syndrome, portal vein thrombosis, or death | 8 weeks | 
| All clinical events | All clinical events were defined as occurrence rebreeding, ascitic fluid infection, hepatorenal syndrome, hepatopulmonary syndrome, portal vein thrombosis, or death | 6 months |