Actively Recruiting
NRP vs DHOPE vs COR-NMP in ECD-DCD Donation
Led by Erasmus Medical Center · Updated on 2022-04-14
150
Participants Needed
1
Research Sites
382 weeks
Total Duration
On this page
Sponsors
E
Erasmus Medical Center
Lead Sponsor
U
University Medical Center Groningen
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
NRP vs DHOPE vs COR-NMP in ECD-DCD Donation
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Donor after circulatory death (Maastricht type III and V)
- Donor age above 50 years and below 75 years
You will not qualify if you...
- Any malignancy except primary non-metastatic central nervous system tumors, non-melanoma skin tumors, or cured cancers
- Active infections including sepsis, meningitis, HIV, rubella, rabies, herpes zoster, or tuberculosis
- Intravenous drug abuse
- Unknown cause of death
- For NRP: donors with BMI above 35 or transaminases above 1000 U/I not decreasing before donation
AI-Screening
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Trial Site Locations
Total: 1 location
1
Erasmus MC
Rotterdam, South Holland, Netherlands
Actively Recruiting
Research Team
J
Jeroen de Jonge, Dr.
CONTACT
F
Fenna J van der Heijden, Drs.
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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