Back to resultsHepQuant to Predict Hepatic Encephalopathy After TIPS
Primary Purpose
Hepatic Encephalopathy, Cirrhosis, Liver
Status
Withdrawn
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
HepQuant
Sponsored by
About this trial
This is an interventional diagnostic trial for Hepatic Encephalopathy
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).
Sites / Locations
- Northwestern University
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
HepQuant Testing
Arm Description
Outcomes
Primary Outcome Measures
Onset of Hepatic Encephalopathy
Secondary Outcome Measures
Full Information
NCT ID
NCT04664621
First Posted
December 6, 2020
Last Updated
August 5, 2022
Sponsor
Northwestern University
Collaborators
HepQuant, LLC
1. Study Identification
Unique Protocol Identification Number
NCT04664621
Brief Title
HepQuant to Predict Hepatic Encephalopathy After TIPS
Official Title
HepQuant to Predict Hepatic Encephalopathy in Patients Who Receive Transjugular Intrahepatic Portosystemic Shunt (TIPS) for Refractory Ascites - a Pilot Study
Study Type
Interventional
2. Study Status
Record Verification Date
August 2022
Overall Recruitment Status
Withdrawn
Why Stopped
Grant expired
Study Start Date
February 25, 2020 (Actual)
Primary Completion Date
September 30, 2021 (Actual)
Study Completion Date
September 30, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Northwestern University
Collaborators
HepQuant, LLC
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatic Encephalopathy, Cirrhosis, Liver
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
HepQuant Testing
Arm Type
Experimental
Intervention Type
Diagnostic Test
Intervention Name(s)
HepQuant
Intervention Description
Patients undergoing TIPS procedure will receive a HepQuant test prior to and then after TIPS.
Primary Outcome Measure Information:
Title
Onset of Hepatic Encephalopathy
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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).
Facility Information:
Facility Name
Northwestern University
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
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HepQuant to Predict Hepatic Encephalopathy After TIPS
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