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 @ 1:34 AM
Ignite Modification Date:
2025-12-25 @ 1:34 AM
NCT ID:
NCT01013194
Eligibility Criteria:
Inclusion Criteria:
* Clinical diagnosis (evidence of chronic liver disease, presence of ascites and/or esophageal varices upon superior digestive endoscopy and/or ultrasound evidence of portal hypertension) or histological diagnosis of liver cirrhosis with any etiology.
* Serious liver failure documented by a score ≥ B8 based on the Child-Pugh-Turcotte classification and/or MELD score ≥ 14.
* Informed consent to the study signed by the patient.
Exclusion Criteria:
* MELD score ≥ 25
* Hepatocellular carcinoma (HCC)
* Portal vein thrombosis
* Serious cardiovascular or respiratory disease, or other medical condition which may threaten patient's life in the subsequent three months
* Admission to the Intensive Care Unit (ICU)
* Hemodynamic instability (MAP \< 55 mmHg)
* Use of vasoactive drugs (Epinephrine, Norepinephrine, Vasopressin, Dopamine, Terlipressine
* Type-1 (acute) hepatorenal syndrome
* Levels of serum creatinine \>2 mg/dl and/or creatinine clearance \<30-40 ml/min
* Sepsis, active infection or spontaneous bacterial peritonitis
* Active gastrointestinal bleeding or recent gastrointestinal bleeding episode (in the previous 4 weeks)
* Active alcohol abuse
* Severe alcoholic hepatitis
* Pulmonary hypertension (PAP \> 35 mmHg)
* History of neoplasia
* Pregnancy
* Non Sicilian residency
* HBV DNA positive
* HIV infection
* Drug addiction
* Age \< 18 years
* Transjugular intrahepatic portosystemic shunt (TIPS) placed in the previous month
* Contraindications to the procedure (e.g., related to the splenic artery: aneurysm, kinking, thrombosis, splenic-renal shunt; related to the spleen: large angioma).
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
70 Years
Study:
NCT01013194
Study Brief:
Protocol Section:
NCT01013194