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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age50-75
SponsorErasmus Medical Center

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 volunteers

Qualifiers

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

Design model

Case-control

Time perspective

Prospective

Treatments tested in this trial

  • NRP

    Procedure/Surgery

    Normothermic Regional Perfusion

  • DHOPE

    Procedure/Surgery

    Dual Hypothermic Oxygenated Perfusion

  • COR-NMP

    Procedure/Surgery

    Controlled Oxygenated Rewarming Normothermic Machine Perfusion

Treatment groups

150 Participants
are divided into 2 treatment groups
Group A: Non ECD2 interventions
Group B: ECD3 interventions

Trial outcomes

Primary outcomes

1

Organ utilization rate in percentage

Number of transplanted organs divided by number offered organs

Time frame
01-01-2022 to 01-05-2023
2

Survival in days

Patient and graft survival

Time frame
1 year post transplantation
3

Cost effectiveness in difference between treatments in euro's

All medical costs resulting from treatment

Time frame
One year post transplantation

Secondary outcomes

1

Cumulative complications summarized by the comprehensive complication index (CCI)

Complications will be ranked by the CCI

Time frame
One year post transplantation
2

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.

Time frame
One year post transplantation
3

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.

Time frame
During peritransplant admission, up to discharge.
4

Number of patients with Early allograft dysfunction (EAD)

EAD is defined as patient or graft death before the post-operative day (POD) 90

Time frame
Post operative day 90

Other outcomes

Sponsors and contacts

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Erasmus Medical Center

Lead sponsor

University Medical Center Groningen

Collaborator

Leiden University Medical Center

Collaborator