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 @ 4:29 AM
Ignite Modification Date:
2025-12-25 @ 4:29 AM
NCT ID:
NCT01201720
Eligibility Criteria:
Inclusion Criteria:
* Age between 18 and 80 years old
* Hepatic cirrhosis diagnosed by biopsy or clinical, analytic and ultra sound data.
* acute on chronic liver failure: defined by an acute deterioration in hepatic function produced in 2-4 weeks with jaundice (total serum bilirubin ≥ 5 mg/dl ) and hepatic encephalopathy (≥ grade 2) and/or renal insufficiency (serum creatinine ≥ 2 mg/dl)
Exclusion Criteria:
* Neoplasm disease including hepatocarcinoma which exceed Milan criteria (1 tumour \> 5cm, up to 3 tumours \<3 cm)
* Active bacterial or fungal infection with hemodynamic instability which require the utilization of vasoactive drugs at moderate dose (\>0,5 μg/Kg/min of noradrenaline)
* Structural moderate to severe cardiopathy (Cardiac Index \<2l/min/m2)
* Chronic renal insufficiency in treatment with haemodialysis
* Chronic moderate o severe pulmonary disease (maximum expiratory volume in a second \<50%)
* Active transplant
* human immunodeficiency virus infection
* Pregnancy or lactation
* Acute respiratory distress syndrome (P02/Fi02\< 200mm Hg) or acute lung injury (P02/Fi02\< 300mm Hg)
* Hemodynamic instability (\>0,5 μg/Kg/min of noradrenaline)
* Bleeding in the digestive tract in the previous 72h to the treatment
* Severe coagulopathy: INR ≥ 3.0 (Quick ≤ 20%) and/or platelets \< 30000//mm3
* Extrahepatic cholestasis
* Hepatobiliary surgery in the last 6 months (except laparoscopic Cholecystectomy)
* Concentrations bilirubin ≥ 5mg/dl during the period above 4 weeks previous to inclusion
* Concomitant participation in an other clinical trial
* Drug addiction
* Mental status which does not allow the patient to understand the trial, with the exception of hepatic encephalopathy.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT01201720
Study Brief:
Protocol Section:
NCT01201720