End-stage liver disease needing liver transplantation
Conditions
Interventions
Prolonged end-ischemic DHOPE (8-12ºC) using a Liver Assist device until implantation the following morning (=4 hours).
Sponsors
UMCG
Eligibility
Inclusion criteria
Inclusion criteria: Given informed consent Adult patients (=18 years old) Donors with a body weight =40 kg DCD (n=6 per arm) or DBD (n=12 per arm) grafts
Exclusion criteria
Exclusion criteria: Simultaneous participation in another trial potentially influencing this trial Simultaneous combined organ transplantation Mental conditions rendering the subject incapable to understand the nature, scope, and consequences of the trial HU status Laboratory MELD score >30 Recipient tested positive for HIV DCD Maastricht category V DCD donors >60 years old Donor with untreated HIV/HBV/HCV Estimated graft steatosis >30% Split or partial liver grafts Domino donor livers Living donor liver grafts
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To study the feasibility and safety of end-ischemic DHOPE-PRO (=4 hours) of donor livers, by assessing the occurrence of preservation-related SAEs and SADEs during machine perfusion (including graft discard during perfusion), and within 30 days after transplantation. | — |
Secondary
| Measure | Time frame |
|---|---|
| • Biliary complications (including anastomotic and non-anastomotic biliary strictures) leading to a surgical or endoscopic intervention within 12 months after liver transplantation. • Actuarial graft and patient survival at 12 months after liver transplantation. • Incidence of acute kidney injury according to the KDIGO criteria27. • Biochemical analysis of graft function and ischemia-reperfusion injury at postoperative day 0-10, and at 1, 3, 6, and 12 months after transplantation, including serum levels of alanine aminotransferase, aspartate aminotransferase, alkaline phosphatase, gamma-glutamyl transferase, total bilirubin, and international normalized ratio, and with the calculation of graft function assessment scores, including Model for Early Allograft Function (MEAF)28 and Liver Graft Assessment Following Transplantation (L-GrAFT).29 • Length of stay at the intensive-care-unit and total hospital length of stay • Perfusion characteristics during DHOPE, including vascular flow, pressure, resistance, and oxygenation and temperature of the perfusate at every 30 minutes • Postoperative complications according to the Clavien-Dindo classification as well as the comprehensive complications index30 within 30 days after liver transplantation. | — |
Contacts
Public ContactVincent de Meijer
University Medical Center Groningen
Outcome results
None listed