NCT05327478 NRP vs DHOPE vs COR-NMP in ECD-DCD Donation
| NCT ID | NCT05327478 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Erasmus Medical Center |
| Condition | Liver Transplant |
| Study Type | OBSERVATIONAL |
| Enrollment | 150 participants |
| Start Date | 2022-01-01 |
| Primary Completion | 2024-05-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 150 participants in total. It began in 2022-01-01 with a primary completion date of 2024-05-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
Inclusion criteria: * DCD donor (Maastricht type III and V) * Age above 50 years old and below 75 years old Exclusion criteria: * 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
Contact & Investigator
Jeroen de Jonge, Dr.
PRINCIPAL INVESTIGATOR
Erasmus Medical Center
Frequently Asked Questions
Who can join the NCT05327478 clinical trial?
This trial is open to participants of all sexes, aged 50 Years or older, up to 75 Years, studying Liver Transplant. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05327478 currently recruiting?
Yes, NCT05327478 is actively recruiting participants. Contact the research team at j.dejonge.1@erasmusmc.nl for enrollment information.
Where is the NCT05327478 trial being conducted?
This trial is being conducted at Rotterdam, Netherlands.
Who is sponsoring the NCT05327478 clinical trial?
NCT05327478 is sponsored by Erasmus Medical Center. The principal investigator is Jeroen de Jonge, Dr. at Erasmus Medical Center. The trial plans to enroll 150 participants.