Project Details
Projekt
Pilot, open, prospective, randomized, multicenter trial on quality assessment of declined liver grafts by normothermic Ex vivo machine perfusion for decreasing time to Transplantation [ExTra trial]
Applicant
Professor Dr. Nathanael Raschzok
Subject Area
General and Visceral Surgery
Term
since 2024
Project identifier
Deutsche Forschungsgemeinschaft (DFG) - Project number 543051616
Liver transplantation in Germany is characterized by a critical shortage of acceptable grafts and a high mortality on the waiting list, while a significant number of organs are declined due to quality concerns. As shown in pilot studies in the UK, Netherlands, Australia, and the United States, declined liver grafts could potentially be used for transplantation after quality assessment by normothermic ex vivo liver machine perfusion (NMP). The ExTra trial is designed as randomized controlled trial (RCT) with a specific focus on patients with a model for end-stage liver disease (MELD) score ≤25 that are not eligible for (non)standard MELD exceptions. This cohort of patients suffers from a significantly extended waiting time to transplantation with inherent increased mortality while on the waitlist (own unpublished data). The aim of the ExTra trial is to show that ´time-to-transplant´ of these patients is shortened through use of grafts which were initially declined for transplantation but fulfil specified quality criteria on normothermic ex vivo machine perfusion assessment. A total of 186 patients will be randomized in a 1:1 fashion to the experimental arm, which consists of a 12-months option to receive a liver graft that was declined by all German transplant centers but meets specified quality criteria, in addition to listing for liver transplantation through the standard allocation process, or the control arm (i.e., waitlist registration for liver transplantation through the standard allocation process). Death, MELD>25 or recovery are considered competing events, patients remaining on the waiting list will be censored. Declined liver grafts considered for quality assessment must not have macrovesicular steatosis >60%, fibrosis >stage F3 or cirrhosis, and a graft weight between 1 - 2.5 kg. The decision to use or decline the graft will be made at least 4 hours after the start of perfusion, depending on previously published viability criteria for initially declined liver grafts (lactate clearance, bile production, ect.).
DFG Programme
Clinical Trials
