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 @ 1:23 AM
Ignite Modification Date:
2025-12-25 @ 1:23 AM
NCT ID:
NCT01412593
Eligibility Criteria:
Inclusion Criteria:
* Age \>18 years
* Clinically diagnosed liver cirrhosis by any of the following: ultrasound/MRI/ CT/ + tissue biopsy.
* MELD score ≥ 18 and \<35
* Ability to sign an informed consent
* Refused by liver transplant program or labeled as not a liver transplant candidate, decided by at least 3 transplant physicians
Exclusion Criteria:
* On a liver transplantation waiting list
* Questionable diagnosis of cirrhosis
* Prior history of organ transplantation
* Past history of malignancy within the 2 years prior to inclusion
* Probable or diagnosis of hepatocellular carcinoma
* Major hepatic vascular thrombosis (hepatic artery, or portal or hepatic veins)
* Serious cardiovascular or respiratory disease, or other medical condition with a high anticipated mortality within twelve months
* Current or recent (within the past 4 weeks) use of vasoactive drugs (Epinephrine, Norepinephrine, Vasopressin, Dopamine, terlipressin)
* Type-1 (acute) hepatorenal syndrome
* Levels of serum creatinine \>150 µmol/ml and/or creatinine clearance \<30 ml/min (as calculated by MDRD system)
* Documented or suspected ongoing infection
* Active or recent gastrointestinal bleeding episode (in the previous 4 weeks)
* Active alcohol abuse extending to within the previous six months
* Pulmonary hypertension (PAP \> 35 mmHg), porto-pulmonary hypertension or hepatopulmonary syndrome
* Pregnancy
* HIV infection
* Active or past drug addiction within the preceding 6 months
* History of serious or uncontrolled psychiatric disease or depression
* Contraindications to the angiography procedures (e.g. arterial aneurysm, kinking, thrombosis)
* Contraindications for bone marrow biopsy (e.g. bleeding diathesis)
* Prior shunt operative shunt procedure
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT01412593
Study Brief:
Protocol Section:
NCT01412593