Liver transplant Surgery
Conditions
Interventions
Treatment arm 1: livers transplanted after preservation on the OrganOx metra device, the methodology for current clinical practice for liver transplantation is observed.
Treatment arm 2: Retrospecti
Sponsors
OrganOx Ltd (UK)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Organ inclusion criteria 1. Livers from male or female adult donors (18 years or greater) 2. Accepted for transplantation using current (standard and extended) criteria 3. Both heart-beating (DBD) and non-heart-beating (DCD) donor organs may be included Recipient Inclusion criteria 1. Male or female, aged 18 years or older 2. On the waiting list for liver transplantation at King?s College Hospital, London. 3. Provided informed consent for participation in the study 4. Able and willing to comply with all study requirements (in the opinion of the investigator or nominated deputy)
Exclusion criteria
Exclusion criteria: Organ exclusion criteria 1. Livers offered from a donor hospital that is located more than 3 hours travelling time (by road) of both King?s College Hospital and Oxford. 2. Donors in whom the liver is planned to be split. 3. Donor livers that would not be accepted under current (King?s College Hospital) criteria. 4. Livers taken from donors aged 160 mmol/litre) at the time of liver retrieval. Recipient Exclusion criteria The participant may not enter the study if ANY of the following apply: 1. Not willing to, unable or not capable to provide informed consent 2. Recipients aged less ?18 years 3. Undergoing transplant for fulminant hepatic failure 4. Undergoing re-transplantation. 5. Undergoing transplantation of other organ(s) in addition to the liver 6. Any other significant disease or disorder which, in the opinion of the Investigator, may either put the participant at risk by participating in the study, or may influence the result of the study, or the participant?s ability to participate in the study. 7. Not suitable for any other reason, in the opinion of the Investigator, to take part in the study. 8. Enrolled in clinical studies of other unlicensed therapy. 9. Participated in another research study involving an investigational product in the previous 12 weeks. 10. Pregnant or nursing mothers
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Graft survival at 30 days | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Histological post-reperfusion biopsies (H&E and immunohistochemistry) 60 minutes after arterial reperfusion (before abdominal closure) 2. Markers of endothelial damage and pro-inflammatory cytokines (TNF, IL-6, vWF) (postoperative) 3. Markers of liver function (Bilirubin, Alkaline phosphatase, GGT, AST, creatinine (postoperative) 4. Six month magnetic resonance cholangiopancreatography (MRCP) appearances 5. Six month graft survival 6. Six month patient survival | — |
Countries
United Kingdom
Outcome results
None listed