Cirrhosis, Portal Vein Thrombosis
Conditions
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.
Interventions
DRUGRifaximin
400mg bid for 8 weeks
Sponsors
Shanghai Zhongshan Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 | 8 weeks | All clinical events were defined as occurrence rebreeding, ascitic fluid infection, hepatorenal syndrome, hepatopulmonary syndrome, portal vein thrombosis, or death |
Countries
China
Contacts
Primary ContactXiaoquan HUANG, M.D.
Backup ContactShiyao CHEN, M.D.& Ph.D
Outcome results
None listed