Improving liver transplant outcomes using machine perfusion techniques

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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
• Email: sanchez_fueyo@kcl.ac.uk
• Phone: 02078485883

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.