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Procedure
TIPS Procedure for Ascites
N/A
Waitlist Available
Led By Eric J Hohenwalter, MD
Research Sponsored by Medical College of Wisconsin
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Patients with indications as established by the ACR-SIR-SPR practice parameters: prophylaxis against recurrent variceal bleed in high-risk patients, portal hypertensive gastropathy or intestine-opathy, refractory ascites, hepatic hydrothorax, hepatopulmonary syndrome, hepatorenal syndrome, decompression of portosystemic collaterals prior to abdominal surgical procedures, Technically successful creation of a TIPS shunt, defined as creation of a portosystemic shunt with post TIPS creation portosystemic gradient of ≤ 12 mmHg
All patients undergoing elective TIPS who meet at least one of the criteria: Right atrial pressure (RAP) ≥ 15mm Hg; OR Change in RAP ≥ 10mm Hg; OR Peak systolic velocity ratio (PSRV) pressure ≥ 46mm Hg
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from insertion of tips to 2 years post tips
Awards & highlights
Study Summary
This trial is being done to determine the impact of the TIPS procedure on cardiac function by collecting data during the TIPS procedure.
Who is the study for?
This trial is for adults over 18 who need a TIPS procedure to manage refractory ascites, which is fluid buildup in the abdomen. They must have certain heart pressure levels or are undergoing elective TIPS as per established medical guidelines. People with GI bleeding, Budd-Chiari syndrome, or mesenteric vein thrombosis can't participate.Check my eligibility
What is being tested?
The study evaluates how the TIPS procedure affects heart function by monitoring heart pressures during and after the operation using echocardiograms. The devices used are standard; it's their impact on cardiac performance that's being studied.See study design
What are the potential side effects?
Potential side effects of the TIPS procedure may include abdominal pain, fever, shunt blockage or malfunction, changes in mental state due to liver bypassing (hepatic encephalopathy), and bruising or soreness at the neck where catheter was inserted.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have had a successful TIPS procedure for my liver condition.
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I am eligible for TIPS and have high heart or blood pressure measurements.
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I am 18 years old or older.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ from insertion of tips to 2 years post tips
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from insertion of tips to 2 years post tips
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Cardiac related events
Secondary outcome measures
Clinical success
Complications
Overall survival
+1 moreOther outcome measures
Correlation of cardiac events with laboratory values
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Study - Transjugular Intrahepatic Portosystemic Shunt (TIPS)Experimental Treatment1 Intervention
Right Atrial Pressure (RAP) ≥ 15mmHg or change in RAP ≥ 10 mmHg or Peak Systolic Right Ventricular (PSRV) Pressure ≥ 46 mmHg
Group II: Control - Transjugular Intrahepatic Portosystemic Shunt (TIPS)Active Control1 Intervention
Normal hemodynamic parameters
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Who is running the clinical trial?
Medical College of WisconsinLead Sponsor
609 Previous Clinical Trials
1,162,541 Total Patients Enrolled
1 Trials studying Ascites
Radiological Society of North AmericaOTHER
25 Previous Clinical Trials
1,759 Total Patients Enrolled
Eric J Hohenwalter, MDPrincipal InvestigatorMedical College of Wisconsin
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I have had a successful TIPS procedure for my liver condition.I am admitted for a GI bleed, have Budd-Chiari syndrome, or TIPS for mesenteric vein thrombosis without specific RAP or PRVS alterations.I am eligible for TIPS and have high heart or blood pressure measurements.I am 18 years old or older.
Research Study Groups:
This trial has the following groups:- Group 1: Study - Transjugular Intrahepatic Portosystemic Shunt (TIPS)
- Group 2: Control - Transjugular Intrahepatic Portosystemic Shunt (TIPS)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are volunteers able to join this research endeavor?
"According to clinicaltrials.gov, the trial first initiated on September 25th 2019 is no longer recruiting participants. However, there are currently 33 other trials actively soliciting enrolment of patients."
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