HepQuant to Predict Hepatic Encephalopathy After TIPS (NCT04664621) | Clinical Trial Compass
WithdrawnNot Applicable
HepQuant to Predict Hepatic Encephalopathy After TIPS
Stopped: Grant expired
United States0Started 2020-02-25
Plain-language 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.
Who can participate
Age range18 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:
* 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).