Comparing techniques for preserving liver grafts from deceased donors
Direct Comparison of NRP With DHOPE and COR-NMP to Maximize the Use of ECD After DCD Donation in the Netherlands
This study is testing three different ways to keep liver donations from deceased donors in good shape to see if any of them can improve their quality and help more patients receive successful transplants.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 150 (estimated) |
| Ages | 50 Years to 75 Years |
| Sex | All |
| Sponsor | Erasmus Medical Center Academic / other |
| Locations | 1 site (Rotterdam, South Holland) |
| Trial ID | NCT05327478 on ClinicalTrials.gov |
What this trial studies
This observational study aims to evaluate the effectiveness of three different organ preservation techniques—Normothermic Regional Perfusion (NRP), Dual Hypothermic Oxygenated Perfusion (DHOPE), and Controlled Normothermic Machine Perfusion (COR-NMP)—in improving the quality of liver grafts from donors after cardiac death (DCD). The study addresses the critical shortage of suitable liver grafts by exploring how these techniques can mitigate the risks associated with DCD grafts, such as primary non-function and biliary complications. By simulating physiological conditions during the initial hours post-cardiac death, the study seeks to enhance graft viability and reduce the need for retransplantation or patient morbidity.
Who should consider this trial
Good fit: Ideal candidates for this study are deceased donors aged between 50 and 75 years who meet specific criteria for DCD.
Not a fit: Patients with active infections, malignancies, or certain health conditions such as high BMI or elevated transaminases may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could significantly increase the availability of viable liver grafts for transplantation, potentially saving lives.
How similar studies have performed: Previous studies have shown promise in using machine perfusion techniques for organ preservation, indicating potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Rotterdam, South Holland
- Erasmus MC — Rotterdam, South Holland, Netherlands (Recruiting)
Study contacts
- Principal investigator: Jeroen de Jonge, Dr. — Erasmus Medical Center
- Study coordinator: Jeroen de Jonge, Dr.
- Email: j.dejonge.1@erasmusmc.nl
- Phone: +31643904182
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.