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NCT07899853
In-situ vs Ex-situ Liver Preservation
Conditions: Liver Disease (Alcoholic or Not), Transplantation
Sex: All
Ages: 16 Years – N/A
Healthy volunteers: No
Phase: NA
Enrollment: 752
Sponsor: Leiden University Medical Center
Location: University Medical Center Groningen Groningen
Summary
The goal of this Randomized Controlled Trial is to learn what machine preservation method is most clinically effective for liver transplantation (LTx) after donation after circulatory death (DCD). The main questions it aims to answer are:
* What perfusion method has the lowest death censored biliary complication rate at 1-year post LT?
* Are there differences in the Core Outcome Set of liver transplantation outcomes?
* Are there any differences in utilization outcomes?
* Are there any differences in cost effectiveness?
* Are there any differences in patient quality of life?
* Are there any differences in resource utilization?
Researchers will compare preservation using in-situ abdominal normothermic regional perfusion (aNRP) to (dual) hypothermic oxygenated perfusion (DHOPE) or DHOPE followed by controlled oxygenated rewarming and normothermic machine perfusion (DHOPE-COR-NMP).
Nothing will change from clinical practice for the liver recipients.
Eligibility Criteria
Inclusion Criteria:
* All DCD donor livers (donor=\>16 years) accepted for transplantation in the Netherlands
Exclusion Criteria:
* HU recipients
* Logistical or technical constraints for machine perfusion
Source: ClinicalTrials.gov (NCT07899853). StuddyBuddy aggregates publicly available trial information.