CompletedPhase 3

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

France211 participantsStarted 2013-09

Plain-language 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 %.

Who can participate

Age range18 Years – 80 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

First episode of overt encephalopathy in patients treated by TIPS

Timeframe: 6 months

Trial details

NCT IDNCT02016196

SponsorUniversity Hospital, Toulouse

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2017-07

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