About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
DCD donor (Maastricht type III and V)
Age above 50 years old and below 75 years old
Disqualifiers
Malignancy (except for primary non-metastatic central nervous system tumors, non-melanoma skin tumors or cured malignancies)
Active infection (sepsis, meningitis, human immune deficiency virus, rubella, rabies, herpes zoster, tuberculosis)
Intravenous drug abuse
Unknown cause of death
Trial population
All potential DCD (Maastricht type III and V) donors above 50 years old and below 75 years old are screened for participation in the national protocol.
Trial design
Case-control
Prospective
Treatments tested in this trial
NRP
Procedure/SurgeryNormothermic Regional Perfusion
DHOPE
Procedure/SurgeryDual Hypothermic Oxygenated Perfusion
COR-NMP
Procedure/SurgeryControlled Oxygenated Rewarming Normothermic Machine Perfusion
Treatment groups
Trial outcomes
Primary outcomes
Organ utilization rate in percentage
Number of transplanted organs divided by number offered organs
Survival in days
Patient and graft survival
Cost effectiveness in difference between treatments in euro's
All medical costs resulting from treatment
Secondary outcomes
Cumulative complications summarized by the comprehensive complication index (CCI)
Complications will be ranked by the CCI
Number of patients with Ischemic cholangiopathy (IC) and anastomotic strictures (AS)
IC is also referred to as non-anastomotic strictures (NAS) or ischemic type biliary lesions (ITBL). IC is defined as a symptomatic patient (e.g., jaundice or cholangitis) with radiological proven irregularity or lumen narrowing in the intra- or extrahepatic donor bile duct in absence of hepatic artery thrombosis. Isolated strictures at the anastomosis are anastomotic strictures.
Length of stay
Length of stay in the hospital during the peritransplant admission, measured in days after the transplantation excluding readmission. Also, length of stay on the intensive care unit during the peritransplant admission, including readmission.
Number of patients with Early allograft dysfunction (EAD)
EAD is defined as patient or graft death before the post-operative day (POD) 90
Sponsors and contacts
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Erasmus Medical Center
Lead sponsor
University Medical Center Groningen
Collaborator
Leiden University Medical Center
Collaborator