HepQuant to Predict Hepatic Encephalopathy After TIPS

Not Applicable

Withdrawn

• Conditions: Hepatic Encephalopathy; Cirrhosis, Liver
• Interventions: Diagnostic Test: HepQuant

• 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

Study Timeline

• Study Start: 2020-02-25
• Study First Submitted: 2020-12-06
• Study First Submitted QC: 2020-12-06
• Study First Posted: 2020-12-11
• Primary Completion: 2021-09-30
• Study Completion: 2021-09-30
• Status Verified: 2022-08
• Last Update Submitted: 2022-08-05
• Last Update Posted: 2022-08-09

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• Status: WITHDRAWN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

Arm && Interventions

Group	Intervention	Description
HepQuant Testing	HepQuant	-

Primary Outcome Measures

Name	Time	Method
Onset of Hepatic Encephalopathy	6 months

Trial Locations

Locations (1)

Northwestern University; 🇺🇸 Chicago, Illinois, United States