The Effect of Rifaximin on Portal Vein Thrombosis

Not Applicable

• Conditions: Portal Vein Thrombosis; Cirrhosis
• Interventions: Drug: Rifaximin

• Registration Number: NCT03631147
• Lead Sponsor: Shanghai Zhongshan Hospital

Brief Summary

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

Detailed Description

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.

Study Timeline

• Status Verified: 2018-08
• Study First Submitted: 2018-08-12
• Study First Submitted QC: 2018-08-12
• Last Update Submitted: 2018-08-12
• Study First Posted: 2018-08-15
• Last Update Posted: 2018-08-15
• Study Start: 2018-09-03
• Primary Completion: 2019-06-30
• Study Completion: 2019-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 96

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Rifaximin treatment group	Rifaximin	Rifaximin 400mg bid for 8 weeks

Primary Outcome Measures

Name	Time	Method
Changes of portal vein thrombosis	8 weeks	The changes of portal vein thrombosis in 8 weeks (include main portal vein, left and/or right portal vein, superior mesenteric vein, et al)

Secondary Outcome Measures

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

Trial Locations

Locations (1)

180 Fenglin Road; 🇨🇳 Shanghai, Shanghai, China