Abdominal Regional Perfusion in Donation After Cardiac Death for Multi-Organ Transplantation

Launched by LONDON HEALTH SCIENCES CENTRE · May 9, 2019

Keywords

ClinConnect Summary

This clinical trial is exploring a new method called Abdominal Regional Perfusion (ARP) to improve the quality of organs donated after cardiac death for liver transplants. The goal is to increase the number of available organs by reconditioning them before transplantation. Researchers will compare the results of liver transplants using ARP with historical data from standard liver transplants to see how well this method works. They will also collect and analyze biological samples from both donors and recipients to find potential markers that could predict how well the transplanted liver will function.

To be eligible for this trial, participants must need a liver transplant due to severe liver disease, such as cirrhosis or liver cancer, and meet certain health criteria. For donors, age, body weight, and health conditions are important factors to determine if their organs are suitable for donation. Participants can expect to undergo standard transplant evaluations, and those selected for the trial will have their liver function closely monitored during the ARP process. This innovative approach aims to enhance the success of liver transplants and ultimately save more lives.

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ALL

Eligibility criteria

• Recipient Criteria:
• • Inclusion Criteria- Indications for Liver transplant include decompensated Cirrhosis of any etiology Model for End-Stage Liver Disease (MELD) score \> 15 with no contraindications to liver transplant as per conventional clinical practice.
• • Acute or fulminant liver failure Advanced malignancy such as HCC, cholangiocarcinoma, neuroendocrine tumor, or other cancer meeting criteria for listing and exception points as per current clinical guidelines.
• • Exclusion Criteria-
• • Inadequate social support for liver transplant
• • Non-compliance with alcohol or narcotic cessation
• • Evidence of uncontrolled infection
• • Other untreated malignancy aside from those listed above
• • Physiologic evidence of frailty based on timed up and go, grip strength, 6 minute walk test, and cognitive testing.
• Donor Criteria:
• • DCD donors offered via TGLN will be considered for assessment via abdominal regional perfusion based on the following parameters. These are in keeping with current criteria for abdominal organ donors.
• • Age: Up to 70 years of age within the initial evaluation period, with plans to expand to 75 y/o if initial results are favourable.
• • BMI: Donor BMI must be less than 30 for consideration
• • DCD donation criteria: Conventional criteria for DCD donation must be met, including no expectation for viable recovery, without meeting criteria for brain death, and expressed desire by family for organ donation.
• • Comorbidity: In the opinion of the on-call transplant surgeon, there should not be excessive comorbidity to exclude organ donation
• • Active infection: There should be no untreated infection.
• • Malignancy: Donors should have no evidence of active malignancy, or in the case of a treated malignancy there should be sufficient interval to rule out recurrence. In select cases, donors with tumors known to be indolent may be considered on a case by case basis.
• Liver transplant release Criteria:
• • One of the major advantages of ARP beyond reconditioning the organ prior to cold storage and transplant, is an opportunity to assess graft function in-situ prior to transplant. The existing literature supports the use of multiple readily available laboratory tests to evaluate graft function prior to transplant. Donor labs will be drawn every 30 minutes from the perfusion circuit to evaluate organ function.
• • Transaminase: Initial transaminases (AST and ALT) drawn at the start of perfusion must be less than 4 times the upper limit of normal and stay below this threshold throughout the reperfusion process to be considered for use with an absolute cut-off of 500
• • Lactate: Grafts will only be used if lactate levels do not rise during perfusion, ideal organs will have a decrease in serum lactate levels by 1.11 mmol/L per hour
• • Macroscopic appearance: On clinical evaluation, there should be no evidence of fibrosis or cirrhosis and organs should not have a macroscopically steatotic appearance.