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:
2025-12-24 @ 9:43 PM
Ignite Modification Date:
2025-12-24 @ 9:43 PM
NCT ID:
NCT02327832
Eligibility Criteria:
Inclusion Criteria:
* Patients eligible for this study include those with decompensated liver cirrhosis with a Child-Pugh score ≥7 (Child-Pugh B) in whom further improvement with current medical treatment is not expected. Other inclusion criteria are age 20 to 75 years and a serum total bilirubin of 3.0 to 5.0 mg/dL, or if the total bilirubin is \<3.0 mg/dL,
* Patients who are still deemed unsuitable as a candidate for general anesthesia.
* Patients must provide informed consent for study participation.
Exclusion Criteria:
* Patients with a current history of malignant neoplasm.
* Patients with gastroesophageal varices at risk of rupture.
* Patients with renal insufficiency and a serum creatinine ≥2 mg/dL.
* Patients with a hemoglobin \<8 g/dL, a platelet count \<50,000/μL, or a prothrombin time \<40%.
* Patients with a performance status of 3 or 4.
* Patients who refuse to consent to allogeneic blood transfusion.
* Women who are pregnant.
* Patients whom their attending physician deems are not suitable candidates for general anesthesia.
* Patients with a current or previous severe allergic reaction to a contrast agent, beef, cow milk, and anesthesia.
* Any patient deemed unsuitable for study inclusion by their attending physician.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
20 Years
Maximum Age:
75 Years
Study:
NCT02327832
Study Brief:
Protocol Section:
NCT02327832