Rifaximin vs Placebo for the Prevention of Encephalopathy in Patients Treated by TIPS

• Status: Completed
• Trial end date: 2017-07-01
• Target enrollment: 0
• Participant gender: All

Summary

TIPS has been used for 20 years, as a means of reducing portal pressure in patients with cirrhosis and portal hypertension related complications. TIPS proved more effective than alternative treatments in controlling or preventing variceal bleeding and refractory ascites. The main drawback of the TIPS procedure is progressive overt hepatic encephalopathy (OHE). Three risk factors for post-TIPS OHE have been identified: age over 65 years, history of previous episodes of OHE, and Child-Pugh score equal to or over 10. However, the incidence of post-TIPS OHE in patients fulfilling these criteria remains close to 35 %.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University Hospital, Toulouse
• Treatments: Rifamycins; Rifaximin

Criteria

Inclusion Criteria:

• cirrhosis with TIPS for ascit treatment or hydrothorax

• prevention digestive bleeding follow up portal hypertension -

• signed consent

Exclusion Criteria:

• hepatocellular carcinoma out of Milan criteria or palliative phase cancer

• Child Pugh score > 12

• TIPS indicated for other indication than bellow

• encephalopathy signs : asterixis or confusion

• Hypersensibility to rifaximin, or derivated of rifamycin

• Patients treated by same class antibacterial

• pregnant woman

• Patient with hepatic transplant