Comparing Normothermic Regional Perfusion, Dual Hypothermic Oxygenated Perfusion, and Controlled Oxygenated Rewarming in Using Extended Criteria Donor Livers After Circulatory Death in Adults
Led by Erasmus Medical Center · Updated on 2022-04-14
150
Participants Needed
1
Research Sites
260 weeks
Total Duration
AI-Summary
What this Trial Is About
This research aims to improve the use of liver grafts from donors after circulatory death DCD, particularly those with extended donor criteria ECD such as older age or certain medical conditions. There is a shortage of suitable liver grafts for transplantation, leading to patient deaths while waiting. The study evaluates different perfusion techniques to better preserve and test these donor livers, potentially increasing their successful use and improving patient and graft survival.
The study compares three perfusion methods used in the Netherlands for DCD liver grafts from donors over 50 years old normothermic regional perfusion NRP, dual hypothermic oxygenated perfusion DHOPE, and controlled oxygenated rewarming normothermic machine perfusion COR-NMP. In the western region, NRP followed by DHOPE is used, while in the eastern and northern regions, standard rapid retrieval followed by DHOPE is done for donors aged 50-60, and COR-NMP is added for donors over 60. These techniques aim to restore blood flow, reduce organ damage, and assess organ viability before transplantation.
Participants are adult liver transplant recipients who receive DCD liver grafts from donors aged 50 to 75 years. Researchers will track organ utilization rates, patient and graft survival, biliary complications, and cost-effectiveness over one year after transplantation. They will also monitor complications, waiting list times, and mortality. Data will be collected from multiple centers to compare outcomes between the perfusion techniques and improve organ preservation and transplant success.
CONDITIONS
Brief Title
NRP vs DHOPE vs COR-NMP in ECD-DCD Donation
Research Team
J
Jeroen de Jonge, Dr.
F
Fenna J van der Heijden, Drs.
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Donor after circulatory death (Maastricht type III and V)
Donor age above 50 years and below 75 years
You will not qualify if you...
Malignancy except for certain cured or non-metastatic tumors
Active infection such as sepsis, meningitis, HIV, rubella, rabies, herpes zoster, or tuberculosis
History of intravenous drug abuse
Unknown cause of donor death
For normothermic regional perfusion: donor BMI above 35 or transaminases above 1000 U/I not decreasing prior to donation
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Monitoring
Duration - Up to 1 year post transplantation
Participants who undergo routine liver transplant procedures including different perfusion techniques are observed to assess organ utilization, survival, and complications.
Periodic visits during the first year after transplantation
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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Published Research Related To This Trial
Pretransplant sequential hypo- and normothermic machine perfusion of suboptimal livers donated after circulatory death using a hemoglobin-based oxygen carrier perfusion solution.
Yvonne de Vries, Alix P M Matton, Maarten W N Nijsten...