HepQuant to Predict Hepatic Encephalopathy After TIPS

NCT ID: NCT04664621

Last Updated: 2022-08-09

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-02-25
• Study Completion Date: 2021-09-30

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

HepQuant Testing

Group Type: EXPERIMENTAL

HepQuant

Intervention Type: DIAGNOSTIC_TEST

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

Interventions

HepQuant

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

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

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).

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

HepQuant, LLC

INDUSTRY

Sponsor Role: collaborator

Northwestern University

OTHER

Sponsor Role: lead

Responsible Party

Justin Boike

Assistant Professor of Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Northwestern University

Chicago, Illinois, United States

Countries

United States

Other Identifiers

STU00210205

Identifier Type: -

Identifier Source: org_study_id