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Immunometabolism of Machine Perfusion Strategies

RecruitingNAAges 18 Years - anyAllKing's College Hospital NHS Trust
NCT06371924 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

There are not enough donated livers for everybody who needs one, and as a result, thousands of patients worldwide are waiting for liver transplants, with many dying while waiting for a life-saving organ. One reason for this shortage is that some usable livers from donors who are considered of high risk are being thrown away out of concern that they might not work well after transplantation due to a problem called ischaemia reperfusion injury (IRI). The discarded organs are mostly those coming from donors who have died due to cardiac arrest (called 'donation after circulatory death' or DCD), with only 27% of them being used in the UK. The quality of these DCD organs could be improved by changing how they are preserved after being removed from the donor. The most commonly used strategy is still to remove the livers and put them in an icebox ('static cold storage' or SCS). The alternative

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📋 Eligibility rules (as published)
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.
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What it tests

  • Machine Perfusion
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Where

2 sites
University Hospitals Birmingham NHS Foundation Trust
Birmingham, United Kingdom
Royal Free London NHS Foundation Trust
London, United Kingdom
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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