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The Effect of Rifaximin on Portal Vein Thrombosis (ERPVT)

Fudan University logo

Fudan University

Status

Unknown

Conditions

Cirrhosis
Portal Vein Thrombosis

Treatments

Drug: Rifaximin

Study type

Interventional

Funder types

Other

Identifiers

NCT03631147
CSY-RFXM-PVT

Details and patient eligibility

About

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

Full 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.

Enrollment

96 estimated patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

96 participants in 2 patient groups

Rifaximin treatment group
Experimental group
Description:
Rifaximin 400mg bid for 8 weeks
Treatment:
Drug: Rifaximin
The control group
No Intervention group

Trial contacts and locations

1

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Central trial contact

Shiyao CHEN, M.D.& Ph.D; Xiaoquan HUANG, M.D.

Data sourced from clinicaltrials.gov

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