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Rifaximin vs Placebo for the Prevention of Encephalopathy in Patients Treated by TIPS
Sponsor: University Hospital, Toulouse
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 %.
Official title: Double Blind Randomized Study, Comparing Rifaximin vs Placebo for the Prevention of Encephalopathy in Patients Treated by TIPS
Key Details
Gender
All
Age Range
18 Years - 80 Years
Study Type
INTERVENTIONAL
Enrollment
211
Start Date
2013-09
Completion Date
2017-07
Last Updated
2026-05-06
Healthy Volunteers
No
Conditions
Interventions
Rifaximin
6 rifaximin caps of 200 mg morning and night, 15 days before and 6 months after TIPS \--------------------------------------------------------------------------------
placebo
6 placebo caps per day morning and night, during 15 days before TIPS and 6 months after TIPS
Locations (13)
UHToulouse
Toulouse, France, France
CHU Angers
Angers, France
Hôpital Jean Verdier
Bondy, France
CHU Bordeaux
Bordeaux, France
CHRU Lille
Lille, France
CHU Marseille
Marseille, France
CHU Nantes
Nantes, France
CHU Beaujon Clichy
Paris, France
CHU Saint-Antoine
Paris, France
Pitié Salpêtrière
Paris, France
CHU Poitiers
Poitiers, France
CHU Rennes
Rennes, France
CHU Tours
Tours, France