Status:
WITHDRAWN
HepQuant to Predict Hepatic Encephalopathy After TIPS
Lead Sponsor:
Northwestern University
Collaborating Sponsors:
HepQuant, LLC
Conditions:
Hepatic Encephalopathy
Cirrhosis, Liver
Eligibility:
All Genders
18+ years
Phase:
NA
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 throu...
Eligibility Criteria
Inclusion
- Subjects over the age of 18 able to provide consent
- Subjects undergoing initial TIPS procedure for the primary indication of treatment of ascites
Exclusion
- 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).
Key Trial Info
Start Date :
February 25 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 30 2021
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT04664621
Start Date
February 25 2020
End Date
September 30 2021
Last Update
August 9 2022
Active Locations (1)
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1
Northwestern University
Chicago, Illinois, United States, 60611