Assessing Declined Liver Grafts With Normothermic Machine Perfusion to Reduce Transplant Waiting Time

NARecruitingINTERVENTIONAL
Enrollment

186

Participants

Timeline

Start Date

June 2, 2025

Primary Completion Date

May 31, 2029

Study Completion Date

December 31, 2030

Conditions
Liver TransplantationLiver DiseasesSurgery
Interventions
DEVICE

Quality Assessment with Normothermic Machine Perfusion (NMP)

"Quality assessment using NMP in the experimental arm is performed according to previously published viability criteria for initially declined liver grafts, which are mandatory for all participating study centers, with minor device-specific modifications. These criteria are based on the Birmingham criteria used in the VITTAL trial for viability assessment of DBD and DCD grafts with the OrganOx Metra device and are comparable to the Groningen criteria previously established with the LiverAssist device, with the exception of biliary viabilit~These criteria are: Lactate clearance \< 2.5 mmol/L, And two or more of the following: Evidence of bile production, maintenance of a perfusate pH \>7.30 (without correction for at least one hour), glucose metabolism (falling perfusate glucose value with consistent downward trend), maintenance of stable arterial and portal venous flows (OrganOx Metra: 150 and 500 mL/min respectively), homogeneous perfusion with soft consistency of the parenchyma."

Trial Locations (1)

State of Berlin

RECRUITING

"Department of Surgery Campus Charité Mitte , Campus Virchow-Klinikum, Charité - Universitätsmedizin Berlin"

Sponsors
All Listed Sponsors
collaborator

German Research Foundation

OTHER

lead

Charite University, Berlin, Germany

OTHER