HepQuant to Predict Hepatic Encephalopathy After TIPS

NCT04664621 | Withdrawn FDA Device

• 1 other identifier: STU00210205
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Hepatic Encephalopathy; Cirrhosis, Liver

Outcome Measures

Primary Outcomes (1)

• Onset of Hepatic Encephalopathy

  6 months

Study Arms (1)

HepQuant Testing

EXPERIMENTAL

Diagnostic Test: HepQuant

Interventions

HepQuant DIAGNOSTIC_TEST

Patients undergoing TIPS procedure will receive a HepQuant test prior to and then after TIPS.

HepQuant Testing

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects over the age of 18 able to provide consent
• Subjects undergoing initial TIPS procedure for the primary indication of treatment of ascites

You may not qualify if:

• 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 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).

Sponsors & Collaborators

• Northwestern University: lead
• HepQuant, LLC: collaborator

Study Sites (1)

Northwestern University

Chicago, Illinois, 60611, United States

Location

MeSH Terms

Conditions

Hepatic Encephalopathy; Liver Cirrhosis

Condition Hierarchy (Ancestors)

Liver Failure; Hepatic Insufficiency; Liver Diseases; Digestive System Diseases; Brain Diseases, Metabolic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Medicine

Study Record Dates

• First Submitted: December 6, 2020
• First Posted: December 11, 2020
• Study Start: February 25, 2020
• Primary Completion: September 30, 2021
• Study Completion: September 30, 2021
• Last Updated: August 9, 2022

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)