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 @ 5:01 AM
Ignite Modification Date:
2025-12-25 @ 5:01 AM
NCT ID:
NCT04421118
Eligibility Criteria:
Criteria: Inclusion Criteria:
* age 18-75 years;
* high-risk treatment failure (e.g.Child-Pugh C or B grade with variceal bleeding);
* conventional drugs and endoscopic treatment of esophageal variceal bleeding are not good;
* End-stage liver disease with variceal bleeding before liver transplantation;
* successful implementation of TIPS;
* good compliance with the requirements formulated by the study;
* with written informed consent.
Exclusion Criteria:
* Liver transplantation in the past or planning liver transplantation in the 6 months;
* Common TIPS contraindications (e.g.NYHA level 2 of congestive heart failure ,history of pulmonary hypertension, portal vein trunk thrombosis, multiple liver cysts,or intrahepatic bile duct dilatation);
* severe liver dysfunction: prothrombin activity \<40% or bilirubin\> 50μmol / L or Child-Pugh score\> 12;
* history of hepatic encephalopathy;
* serum creatinine\> 133μmol / L;
* severe hyponatremia (blood sodium \<125mmol / L);
* uncontrollable infections;
* allergic to intravenous contrast agent;
* subject refused to participate in the trial or without the ability to participate in informed consent;
* previous history of TIPS treatment;
* any comorbidities or conditions that affect the test results as judged by the investigator.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT04421118
Study Brief:
Protocol Section:
NCT04421118