HepQuant to Predict Hepatic Encephalopathy After TIPS

HepQuant to Predict Hepatic Encephalopathy in Patients Who Receive Transjugular Intrahepatic Portosystemic Shunt (TIPS) for Refractory Ascites - a Pilot Study

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.

Study Overview

• Status: Withdrawn
• Conditions: Hepatic Encephalopathy; Cirrhosis, Liver
• Intervention / Treatment: Diagnostic test: HepQuant

• Study Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Illinois
    • Chicago, Illinois, United States, 60611
      • Northwestern University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: DIAGNOSTIC
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: HepQuant Testing	Diagnostic test: HepQuant; Patients undergoing TIPS procedure will receive a HepQuant test prior to and then after TIPS.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Onset of Hepatic Encephalopathy	6 months

Collaborators and Investigators

• Sponsor: Northwestern University
• Collaborators: HepQuant, LLC

Study record dates

Study Major Dates

• Study Start (ACTUAL): February 25, 2020
• Primary Completion (ACTUAL): September 30, 2021
• Study Completion (ACTUAL): September 30, 2021

Study Registration Dates

• First Submitted: December 6, 2020
• First Submitted That Met QC Criteria: December 6, 2020
• First Posted (ACTUAL): December 11, 2020

Study Record Updates

• Last Update Posted (ACTUAL): August 9, 2022
• Last Update Submitted That Met QC Criteria: August 5, 2022
• Last Verified: August 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Liver Failure; Hepatic Insufficiency; Pathologic Processes; Metabolic Diseases; Central Nervous System Diseases; Nervous System Diseases; Liver Diseases; Fibrosis; Brain Diseases, Metabolic; Liver Cirrhosis; Hepatic Encephalopathy; Brain Diseases
• Other Study ID Numbers: STU00210205

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes