Early detection of hepatic encephalopathy after transjugular intrahepatic portosystemic shunt (TIPS) placement.
P
Paul Haste
Primary Investigator
Enrolling By Invitation
18-100 years
All
Phase
N/A
51 participants needed
2 Locations
Brief description of study
Early detection of hepatic encephalopathy after TIPS using EncephalApp Stroop test to screen for covert hepatic encephalopathy (CHE).
Primary Objective: To assess whether there is an association of neurophysiological change on EncephalApp Stroop test (CHE) with the development of overt hepatic encephalopathy (OHE).
Secondary Objective: To assess the time to development of OHE and 30-day OS.
Who is Eligible?
- Provision of signed and dated informed consent form
- Stated willingness to comply with all study procedures and availability for the duration of the study
- Male or female, aged 18 and above
- Diagnosed with portal hypertension requiring TIPS placement.
- Women of reproductive potential must use highly effective contraception such as implants, injectables, combined oral contraceptives, some IUDs, sexual abstinence, or vasectomized partner.
What is Involved?
- Mini-Mental State Examination to assess cognitive function at Visit 1 (10 minutes)
- Color blindness exam at Visit 1 (1 minute)
- EncephalApp test at Visits 1 and 3-6 (5-10 minutes)
- Quality of life survey at Visits 1 and 6 (5 minutes)
All tests/surveys will be performed in the Interventional Radiology clinic during your standard clinic follow-up appointments. There will be no additional appointments required.
Questions about the Study
For questions about the study, contact the IR clinic at 317-948-7569 or 317-944-5006 and ask to leave a message for Dr. Paul Haste or Dr. Nerina DiSomma.
Eligibility of study
You may be eligible for this study if you meet the following criteria:
- Conditions: hepatic encephalopathy
-
Age: Between 18 Years - 100 Years
-
Gender: All
Inclusion Criteria:
In order to be eligible to participate in this study, an individual must meet all of the following criteria:
1. Provision of signed and dated informed consent form
2. Stated willingness to comply with all study procedures and availability for the duration of the study
3. Male or female, aged 18 and above
4. Diagnosed with portal hypertension requiring TIPS placement.
5. Women of reproductive potential must use highly effective contraception such as implants, injectables, combined oral contraceptives, some IUDs, sexual abstinence, or vasectomized partner.
Exclusion Criteria:
An individual who meets any of the following criteria will be excluded from participation in this study:
1. Neuro-cognitive disorders (except depression)
2. Recent illicit drug use within the prior 6 months.
3. Mini-mental state score of <25
4 Red-green color blindness
5. Focal neurological deficits
6. Prior history of overt hepatic encephalopathy (grade 3-4) that was primary reason for hospitalization unless it was due to infection/variceal bleed
7. Participation in a clinical study that may interfere with participation in this study within the prior 6 months.
8. Anything that would place the individual at increased risk or preclude the individual’s full compliance with or completion of the study.
9. Pregnant subjects
10. Prisoners
Updated on
01 Aug 2024.
Study ID: 13536
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