HepQuant to Predict Hepatic Encephalopathy After TIPS

Cirrhosis, Liver Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT04664621
• Other study ID #: STU00210205
• Status: Withdrawn
• Phase: N/A
• Start date: February 25, 2020
• Est. completion date: September 30, 2021

Study information

• Verified date: August 2022
• Source: Northwestern University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: September 30, 2021
• Est. primary completion date: September 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Brain Diseases
• Cirrhosis, Liver
• Hepatic Encephalopathy
• Liver Cirrhosis

Intervention

Diagnostic Test:
• HepQuant
Patients undergoing TIPS procedure will receive a HepQuant test prior to and then after TIPS.

Locations

Country	Name	City	State
United States	Northwestern University	Chicago	Illinois

Sponsors (2)

Lead Sponsor	Collaborator
Northwestern University	HepQuant, LLC

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Onset of Hepatic Encephalopathy		6 months