DCN for ECD Livers

Erasmus University

Status: Completed

Conditions: Liver Transplantation

Treatments: Procedure: DHOPE-COR-NMP

Study type: Observational

Funder types: Other

Identifiers

NCT06804746

MEC-2024-0738

Details and patient eligibility

About

The goal of this observational study is to learn whether extended criteria donor livers can be safely transplanted after sequential hypo- and normothermic machine perfusion in recipients requiring a liver transplant for end-stage liver disease, including a long-term follow-up. The main questions it aims to answer are:

• Death censored graft-survival
• Overall patient survival
• Frequency of frequent post-transplant complications (e.g. non-anastomotic biliary strictures)

Full description

With the increasing shortage of suitable donor livers for transplantation, extended criteria donor (ECD) livers may bridge the gap between available donor organs and donor livers needed. However, these ECD livers are associated with a higher risk of posttransplant complications. With the development of machine perfusion (MP) strategies over the recent years, (dual) hypothermic oxygenated perfusion ((D)HOPE) is established as a safe and effective way to reduce ischemia reperfusion injury. This leads to a decrease in early allograft dysfunction and non-anastomotic biliary strictures (NAS). On the other hand, normothermic machine perfusion (NMP) is mainly used for hepatobiliary functional assessment of liver grafts prior to transplantation. Combining both perfusion techniques through 1 hour of controlled oxygenated rewarming (COR), enables safe selection and transplantation of ECD livers after DHOPE-COR-NMP. Long-term outcomes are now available from two centers.

Enrollment: 143 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Adult patients (>18 years old)
• Donor livers that required resuscitation and viability assessment through the previously published sequential hypo- and normothermic liver machine perfusion (DHOPE-COR-NMP) protocol based on a blood-based perfusate.

Exclusion criteria

• Multiorgan transplantation
• Split liver transplant
• Living donor liver transplantation
• Previous donor organ perfusion (e.g. Normothermic Regional Perfusion)

Trial design

143 participants in 1 patient group

Group 1

Description:

Adult patients (\>18 years) who underwent liver transplantation of donor livers that required resuscitation and viability assessment through the previously published protocol for sequential hypo- and normothermic liver machine perfusion with controlled oxygenated rewarming (DHOPE-COR-NMP) based on a blood-based perfusate.

Treatment:

Procedure: DHOPE-COR-NMP