← Back to Search

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
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
≥ 18 years
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from insertion of tips to 1 year post tips
Awards & highlights
No Placebo-Only Group

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.
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.
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 below
Select...
I am eligible for TIPS and have high heart or blood pressure measurements.
Select...
I am 18 years old or older.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from insertion of tips to 1 year post tips
This trial's timeline: 3 weeks for screening, Varies for treatment, and from insertion of tips to 1 year post tips for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Cardiac related events
Secondary study objectives
Clinical success
Complications
Overall survival
+1 more
Other study objectives
Correlation of cardiac events with laboratory values

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

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
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Study - Transjugular Intrahepatic Portosystemic Shunt (TIPS)
2019
N/A
~50

Find a Location

Who is running the clinical trial?

Medical College of WisconsinLead Sponsor
635 Previous Clinical Trials
1,181,652 Total Patients Enrolled
1 Trials studying Ascites
Radiological Society of North AmericaOTHER
26 Previous Clinical Trials
956 Total Patients Enrolled
Eric J Hohenwalter, MDPrincipal InvestigatorMedical College of Wisconsin

Media Library

Control - Transjugular Intrahepatic Portosystemic Shunt (TIPS) (Procedure) Clinical Trial Eligibility Overview. Trial Name: NCT04050683 — N/A
Ascites Research Study Groups: Study - Transjugular Intrahepatic Portosystemic Shunt (TIPS), Control - Transjugular Intrahepatic Portosystemic Shunt (TIPS)
Ascites Clinical Trial 2023: Control - Transjugular Intrahepatic Portosystemic Shunt (TIPS) Highlights & Side Effects. Trial Name: NCT04050683 — N/A
Control - Transjugular Intrahepatic Portosystemic Shunt (TIPS) (Procedure) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04050683 — N/A
~8 spots leftby Jan 2026
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top