Improving liver transplant outcomes using machine perfusion techniques

Mechanistic Evaluation of Machine Perfusion Strategies in Donation After Circulatory Death Liver Transplantation

This study is testing different machine methods to see if they can better preserve livers from high-risk donors who died from cardiac arrest, with the goal of improving liver transplant success for patients.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 36 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: King's College Hospital NHS Trust (other)
• Locations: 2 sites (Birmingham and 1 other locations)
• Trial ID: NCT06371924 on ClinicalTrials.gov

What this trial studies

This study aims to address the shortage of viable liver transplants by investigating the effectiveness of different machine perfusion strategies for preserving livers from high-risk donors, specifically those who have died from cardiac arrest. The research will compare three machine perfusion methods: normothermic regional perfusion, normothermic perfusion, and hypothermic perfusion, to determine their impact on liver cell health and function. By enhancing the preservation of these livers, the study seeks to reduce the incidence of ischaemia reperfusion injury, which often leads to organ discard. The findings could provide valuable insights into optimizing liver transplant protocols and improving patient outcomes.

Who should consider this trial

Good fit: Ideal candidates include adult patients on the liver transplant waiting list who are suitable to receive a liver from a donation after circulatory death.

Not a fit: Patients who are not on the transplant waiting list or those requiring a second liver transplant will not benefit from this study.

Why it matters

Potential benefit: If successful, this study could significantly increase the number of usable livers for transplantation, potentially saving many lives.

How similar studies have performed: While machine perfusion techniques have been explored, this study represents a novel approach by directly comparing multiple strategies in a controlled setting.

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 receiving super-urgent transplantation for acute and acute-on-chronic liver failure.
3. Patients unable to give full informed consent.

Where this trial is running

Birmingham and 1 other locations

• University Hospitals Birmingham NHS Foundation Trust — Birmingham, United Kingdom (RECRUITING)
• Royal Free London NHS Foundation Trust — London, United Kingdom (RECRUITING)

Study contacts

• Principal investigator: Alberto Sanchez-Fueyo — King's College London
• Study coordinator: Alberto Sanchez-Fueyo

Conditions: Liver Transplantation