Actively Recruiting
Prevention of Post-TIPS Hepatic Encephalopathy by Administration of Rifaximin and Lactulose
Led by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) · Updated on 2025-01-28
238
Participants Needed
6
Research Sites
362 weeks
Total Duration
On this page
Sponsors
A
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Lead Sponsor
E
Erasmus Medical Center
Collaborating Sponsor
AI-Summary
What this Trial Is About
Rationale: Hepatic encephalopathy (HE) is a major and common complication in patients with liver cirrhosis. HE can be classified in the extensive range of neurocognitive deterioration as minimal HE (MHE), covert HE (grade I), or overt HE (OHE, grade II-IV). Liver cirrhosis is the most common cause of portal hypertension (PH). Patients who develop complications of PH, like variceal bleeding or refractory ascites, can benefit from a Transjugular Intrahepatic Portosystemic Shunt (TIPS) placement. Unfortunately, post-TIPS HE is a common and often severe complication. Incidence of new onset or worsening of HE after TIPS is approximately 20-45%. Currently there is no strategy to prevent post-TIPS HE.
CONDITIONS
Official Title
Prevention of Post-TIPS Hepatic Encephalopathy by Administration of Rifaximin and Lactulose
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Elective TIPS placement for refractory ascites or recurrent variceal bleeding with specific clinical criteria
- Age 18 years or older
- Confirmed liver cirrhosis by biopsy, elastography, or combination of radiological and biochemical criteria
- Signed informed consent
You will not qualify if you...
- Any absolute contraindications for TIPS placement
- Use of ciclosporin
- Life-threatening variceal bleeding requiring emergency TIPS placement that cannot be delayed 72 hours
- Age over 80 years
- Non-cirrhotic portal hypertension
- Portal vein thrombosis (main trunk)
- HIV infection
- Current or recent (less than 3 months) use of rifaximin
- Overt neurologic diseases such as Alzheimer's disease or Parkinson's disease
- Pregnant or breastfeeding women
- Patients refusing or unable to sign informed consent
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 6 locations
1
Universitaire Ziekenhuizen Leuven
Leuven, Belgium
Actively Recruiting
2
Academic Medical Centre
Amsterdam, Netherlands
Actively Recruiting
3
University Medical Center Groningen
Groningen, Netherlands
Actively Recruiting
4
Leiden University Medical Center
Leiden, Netherlands
Actively Recruiting
5
Radboud University
Nijmegen, Netherlands
Actively Recruiting
6
Erasmus Medical Center
Rotterdam, Netherlands
Actively Recruiting
Research Team
K
Koos de Wit, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here