Actively Recruiting

Age: 50Years - 75Years
All Genders
ID05327478

Direct Comparison of Normothermic Regional Perfusion, Dual Hypothermic Oxygenated Perfusion, and Controlled Oxygenated Rewarming NMP to Maximize Use of Extended Criteria Donor Livers After Donation After Circulatory Death in the Netherlands

Led by Erasmus Medical Center · Updated on 2022-04-14

150

Participants Needed

1

Research Sites

260 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

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

Who Can Participate

Age: 50Years - 75Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Donor after circulatory death (Maastricht type III and V)
  • Donor age above 50 years and below 75 years
Not Eligible

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

AI-Screening

AI-Powered Screening

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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

Trial Site Locations

Total: 1 location

1

Erasmus MC

Rotterdam, South Holland, Netherlands

Actively Recruiting

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Research Team

J

Jeroen de Jonge, Dr.

F

Fenna J van der Heijden, Drs.

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...

https://pubmed.ncbi.nlm.nih.gov/30588774

Abdominal Normothermic Regional Perfusion in Donation After Circulatory Death: A Systematic Review and Critical Appraisal.

Fenna E M van de Leemkolk, Ivo J Schurink, Olaf M Dekkers...

https://pubmed.ncbi.nlm.nih.gov/32541563