RecruitingNCT05327478

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

Direct Comparison of NRP With DHOPE and COR-NMP to Maximize the Use of ECD After DCD Donation in the Netherlands


Sponsor

Erasmus Medical Center

Enrollment

150 participants

Start Date

Jan 1, 2022

Study Type

OBSERVATIONAL

Conditions

Summary

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

Min Age: 50 YearsMax Age: 75 Years

Inclusion Criteria2

  • DCD donor (Maastricht type III and V)
  • Age above 50 years old and below 75 years old

Exclusion Criteria5

  • 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
  • In the case of a NRP procedure: donors with a BMI above 35 and transaminases above 1000 U/I and not decreasing prior to donation are excluded

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Interventions

PROCEDURENRP

Normothermic Regional Perfusion

PROCEDUREDHOPE

Dual Hypothermic Oxygenated Perfusion

PROCEDURECOR-NMP

Controlled Oxygenated Rewarming Normothermic Machine Perfusion


Locations(1)

Erasmus MC

Rotterdam, South Holland, Netherlands

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NCT05327478


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