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In-situ vs Ex-situ Liver Preservation
Sponsor: Leiden University Medical Center
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.
Official title: IN Situ Versus ex Situ Organ PreservatIon: a Randomized Evaluation in the Netherlands (INSPIRE-NL)
Key Details
Gender
All
Age Range
16 Years - Any
Study Type
INTERVENTIONAL
Enrollment
752
Start Date
2026-11-04
Completion Date
2032-10-01
Last Updated
2026-11-03
Healthy Volunteers
No
Interventions
In-situ perfusion: aNRP
This arm contains of 2 pre-defined strata: SCD-DCD livers: receiving 1 hour of aNRP, ECD-DCD livers: receiving 2 hours of aNRP. Both treatments are standard of care.
Ex-situ perfusion: DHOPE/DHOPE-COR-NMP
This arm contains of 2 pre-defined strata: SCD-DCD livers: receiving DHOPE, ECD-DCD livers: receiving DHOPE-COR-NMP. Both treatments are standard of care.
Locations (3)
University Medical Center Groningen
Groningen, Netherlands
Leiden University Medical Center
Leiden, Netherlands
Erasmus Medical Center
Rotterdam, Netherlands