HepQuant to Predict Hepatic Encephalopathy After TIPS
Not Applicable
Withdrawn
- Conditions
- Hepatic EncephalopathyCirrhosis, Liver
- Registration Number
- NCT04664621
- Lead Sponsor
- Northwestern University
- Brief Summary
A pilot study to determine if a simple blood test can predict patients at risk for significant episodes of confusion and disorientation that can occur in patients who receive an artificial shunt through the liver to control complications of liver disease.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- WITHDRAWN
- Sex
- All
- Target Recruitment
- Not specified
Inclusion Criteria
- Subjects over the age of 18 able to provide consent
- Subjects undergoing initial TIPS procedure for the primary indication of treatment of ascites
Exclusion Criteria
- Prisoners
- Pregnant women
- Subjects undergoing TIPS placement as part of an investigational study outside of usual clinical care
- Subjects taking beta-blocker medications or angiotensin converting enzyme inhibitors
- Subjects with evidence of porto-systemic shunts present on imaging (eg splenorenal shunt)
- Subjects with calculated MELD score >12 based on most recent laboratory values before consent
- Subjects with prior history of overt hepatic encephalopathy (grade 3-4) that was primary reason for hospitalization. Episodes of hepatic encephalopathy that were the consequence of other precipitating event (such as variceal bleeding or infection) will not be considered exclusionary.
- Subjects with a known sensitivity to albumin preparations, any ingredient in the formulation, or components of the container
- Subjects unable to fast for >5 hours prior to the HepQuant administration or subjects who are unable to drink the oral dose of the cholate (~40mL of liquid).
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method Onset of Hepatic Encephalopathy 6 months
- Secondary Outcome Measures
Name Time Method
Related Research Topics
Explore scientific publications, clinical data analysis, treatment approaches, and expert-compiled information related to the mechanisms and outcomes of this trial. Click any topic for comprehensive research insights.
What molecular biomarkers does HepQuant measure to predict hepatic encephalopathy after TIPS?
How does HepQuant's predictive accuracy compare to standard clinical assessments for hepatic encephalopathy in cirrhosis patients?
What are the key pathophysiological mechanisms linking TIPS placement to hepatic encephalopathy development in liver cirrhosis?
Are there specific serum metabolite profiles associated with post-TIPS hepatic encephalopathy risk in patients with refractory ascites?
What alternative biomarker strategies are being explored for early detection of hepatic encephalopathy in liver disease management?
Trial Locations
- Locations (1)
Northwestern University
🇺🇸Chicago, Illinois, United States
Northwestern University🇺🇸Chicago, Illinois, United States