on-randomised, open-label, single-arm, prospective clinical investigation to assess the safety and performance of the Organox Metra, for normothermic perfusion of livers, prior to transplantation and to compare with retrospective data from matched controls

OrganOx Ltd (UK)0 个研究点目标入组 20 人开始时间: 2012年11月27日最近更新: 2018年6月18日

试验速览

•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)

•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 <18 years.
•5. Donors with high donor serum Na+ (> 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

发起方

OrganOx Ltd (UK)