NCT05327478

NRP vs DHOPE vs COR-NMP in ECD-DCD Donation

Recruiting now Last updated 14 April 2022

What this trial tests

trial testing NRP in Liver Transplant in 150 participants. Currently enrolling.

Timeline

1 January 2022

Primary endpoint
1 May 2024

1 May 2029

Quick facts

Lead sponsor	Erasmus Medical Center
Status	Recruiting now
Study type	OBSERVATIONAL
Enrollment	150
Start date	1 January 2022
Primary completion	1 May 2024
Estimated completion	1 May 2029
Sites	1 location across Netherlands

Drugs / interventions tested

• NRP
• DHOPE
• COR-NMP

Conditions studied

• Liver Transplant — all drugs for Liver Transplant →
• Organ Perfusion — all drugs for Organ Perfusion →
• Complication of Surgical Procedure — all drugs for Complication of Surgical Procedure →

Sponsor

Erasmus Medical Center

Who can join

Adults 50 to 75, any sex, with Liver Transplant or Organ Perfusion. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

There is still a discrepancy between the number of liver transplant candidates and the availability of liver grafts, resulting in waiting list mortality. To increase the supply of suitable liver grafts, extended-donor criteria allografts can be used. However, in the case of donation after cardiac death this is not without a risk. Donor after cardiac death (DCD) grafts have increased risk of primary non function and biliary complications, resulting in either retransplantation, patient morbidity or patient death. Due to uncertainty of their quality DCD grafts can be discarded. However, normothermic machine perfusion (NRP) has the potential to overcome these disadvantages of DCD liver grafts. In DCD livers the physiological abdominal circulation is simulated with in vivo, normothermic, oxygenated perfusion during the first two hours after cardiac death. With this perfusion technique, early ischemia can be reversed, surgical damage due to a hasty procedure can be prevented and organs can be tested on viability. In many countries, NRP is obligatory, however this is not the current golden standard in the Netherlands. The primary objective of this study is the utilization of livers after NRP. Secondary study parameters are reasons for graft discard or rejection at proposal, patient- and graft survival, biliary complications, cost assessment of NRP and outcomes of kidney and pancreas transplants. This multicenter, observational study will be performed on adult liver transplant recipients who have been allocated a DCD liver graft (Maastricht type III and V) of a donor above fifty years old. According to current national procurement protocol, grafts procured in region west will be retrieved with NRP followed by dual hypothermic oxygenated perfusion (DHOPE). Grafts retrieved in region East/North will be retrieved using standard rapid retrieval followed by DHOPE, if the donor is aged 50-60. Grafts from donors aged above 60 will undergo controlled oxygenated rewarming normothermic machine perfusion (COR-NMP) after DHOPE.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. The Current Role and Future Applications of Machine Perfusion in Liver Transplantation.
   Staubli SM, Ceresa CDL, Pollok JM. · · 2023 · cited 9× · PMID 37237663 · DOI 10.3390/bioengineering10050593