Cirrhosis, Liver, Hepatic Encephalopathy
Conditions
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.
Interventions
DIAGNOSTIC_TESTHepQuant
Patients undergoing TIPS procedure will receive a HepQuant test prior to and then after TIPS.
Sponsors
HepQuant, LLC
Northwestern University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Onset of Hepatic Encephalopathy | 6 months |
Countries
United States
Outcome results
None listed