Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 2:38 AM
Ignite Modification Date:
2025-12-25 @ 2:38 AM
NCT ID:
NCT06576934
Eligibility Criteria:
Inclusion Criteria:
Patients eligible for inclusion in this trial must meet all of the following criteria:
1. Patients ≥ 18 years and \< 80 years
2. Liver cirrhosis as documented by previous liver biopsy or by a combination of typical clinical, biochemical and sonographic features
3. Ascites as the first single decompensating event with grade 2 ascites and MELD ≥ 15 OR grade 3 ascites
4. INR ≤ 1.5
5. Ability to understand the nature of the trial and the trial related procedures and to comply with them
Exclusion Criteria:
Patients eligible for this trial must not meet any of the following criteria:
1. Treatment refractory or recurrent ascites at the time of study inclusion
2. Patients with concomitant variceal bleeding fulfilling the criteria for pre-emptive TIPS implantation (Child-Pugh class C \< 14 points or Child-Pugh class B \>7 with active bleeding at initial endoscopy or hepatic venous pressure gradient \[HVPG\] \> 20 mmHg at the time of bleeding)
3. Budd-Chiari syndrome
4. Portal vein thrombosis (PVT)
5. Spontaneous bacterial peritonitis (SBP)
6. Uncontrolled systemic infection (defined as an increase of \> 20% if inflammatory parameters \[C-reactive protein, procalcitonin, leukocytes\] and/or sepsis as a reason for development of ascites
7. Cardiac cirrhosis (defined as the development of liver cirrhosis in a patient with cardiac heart failure due to primary cardiac disease)
8. Clinical significant cardiac disease (NYHA ≥II)
9. Untreated valvular heart disease: middle to high-grade valve stenosis or insufficiency (applies to mitral, tricuspid, aortic and pulmonary valves)
10. Diastolic dysfunction grade III, stated by transthoracic echocardiogram (TTE)
11. Reduced left ventricular ejection fraction ≤50%
12. Pulmonary hypertension (mean pulmonary arterial pressure \> 45 mmHg)
13. Bilirubin \> 3 mg/dl
14. Obstructive cholestasis
15. Hepatorenal syndrome type AKI (HRS-AKI)
16. Acute on chronic liver failure
17. Benign liver tumor within the potential puncture tract
18. Patient after liver transplantation
19. Prior TIPS implantation
20. Ongoing and/or recurrent hepatic encephalopathy (grade \>II)
21. Active tumor disease including hepatocellular carcinoma defined as need for chemotherapy, radiation therapy, interventional or surgical treatment
22. New onset of antiviral treatment for chronic hepatitis B virus (HBV) infection within the last 3 months
23. Untreated chronic hepatitis C virus (HCV) infection
24. Life expectancy \<1 year
25. Pregnant or breastfeeding women
26. Patients without the legal capacity who are unable to understand the nature, significance and consequences of the study
27. Simultaneous participation in other interventional trials which could interfere with this trial; simultaneous participation in registry and diagnostic trials is allowed
28. Person who is in a relationship of dependence/employment with the sponsor or the investigator
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT06576934
Study Brief:
Protocol Section:
NCT06576934