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 @ 9:36 PM
Ignite Modification Date:
2025-12-24 @ 9:36 PM
NCT ID:
NCT01841632
Eligibility Criteria:
Inclusion Criteria:
* Patients ≥18 years of age undergoing allogeneic liver transplantation
* Absence of any familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule
* Written informed consent prior to any study procedures
Exclusion Criteria:
* Known allergies to bovine or porcine products or any other ingredients of the product
* Patients older than 65 years of age
* Patients listed in a high-urgency status that would not allow proper preparation of the study interventions
* Patients receiving a secondary liver graft (Re-Transplantation)
* Double organ transplant recipients
* Pre-existing renal failure that requires or has required hemodialysis within the last year
* Pulmonary function: FEV1, FVC, DLCO ≤50% predicted
* Cardiac function: left ventricular ejection fraction ≤50%
* HIV seropositive, varicella virus active infection or any other clinically relevant infection
* History of any malignancy (including lymphoproliferative disease and hepatocellular carcinoma) except for squamous or basal cell carcinoma of the skin that has been treated with no evidence of recurrence
* Unstable myocardium (evolving myocardial infarction), cardiogenic shock
* Females of childbearing potential (hormonal status and gynecological consultation required)
* Patients with portal vein thrombosis
* Patients with a history of pulmonary embolism
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT01841632
Study Brief:
Protocol Section:
NCT01841632