Immunometabolism of Machine Perfusion Strategies

Launched by KING'S COLLEGE HOSPITAL NHS TRUST · Apr 12, 2024

Keywords

ClinConnect Summary

This clinical trial is studying different methods of preserving donated livers, particularly those from donors who have died from cardiac arrest, to improve their chances of functioning well after transplantation. Many of these livers are currently discarded due to concerns about their quality, but researchers believe that using machine-based techniques to preserve them could make a significant difference. The trial will compare three preservation methods: traditional cold storage, a process called normothermic regional perfusion where blood is pumped through the liver while it's still in the donor's body, and a method called hypothermic machine perfusion that uses cold fluid to help preserve the liver outside the body. The goal is to find out which method works best and to better understand how these techniques improve liver quality.

To participate in the trial, donors must meet certain criteria, such as being at least 18 years old and having consent from their family for the liver to be used for research. The trial is also looking for transplant recipients who are 18 or older, are on the waiting list for their first liver transplant, and are willing to participate. Participants can expect to have their livers preserved using one of the methods being studied before they are evaluated for suitability for transplantation. This research is important as it could help increase the number of usable livers available for those in need of a life-saving transplant.

Gender

ALL

Eligibility criteria

• • Inclusion Criteria Donor inclusion criteria
• • 1. DCD category III donors considered for abdominal organs-only retrieval.
• • 2. Donor age ≥18 years.
• • 3. Retrieval procedure allocated to KCH or UHB NORS teams.
• • 4. Donor liver accepted for a patient at KCH or UHB transplant waiting list via the standard offering process.
• • 5. Functional donor warm ischaemia (defined as a period between the systolic blood pressure \<50mmHg and aortic cold flush) ≤30 minutes.
• • 6. Donor BMI \<35kg/m2.
• • 7. Predicted cold ischaemic time \<8 hours.
• • 8. Donor family has given consent to use donated liver for research.
• • Transplant recipient inclusion criteria
• • 1. Recipients 18 years of age or older.
• • 2. Listed on an elective transplant waiting list.
• • 3. First liver transplantation.
• • 4. Suitable to receive a DCD graft based on the liver listing MDT.
• • 5. Willingness to consent for the study participation.
• • Exclusion Criteria Donor exclusion criteria
• • 1. Donor is HIV, hepatitis B (HBV HbsAg) or hepatitis C (HCV RNA) positive. HBV anti-Hbc positive donors are acceptable.
• • 2. Macroscopic evidence of fibrosis.
• • 3. Liver weight \>2.5 kg.
• • 4. Retrieval of cardiothoracic organs intended for transplantation.
• • 5. Any medical condition that, in the opinion of the principal investigator, would interfere with safe completion of the trial.
• • Transplant recipient exclusion criteria
• • 1. High-risk surgical candidates (i.e. presence of extensive portomesenteric thrombosis, previous complex upper abdominal surgery).
• • 2. Patients undergoing liver re-transplantation or multi-organ transplantation.
• • 3. Patients receiving super-urgent transplantation for acute and acute-on-chronic liver failure.
• • 4. Patients unable to give full informed consent.