Continued Access Protocol Study for The Use of the OrganOx Metra Normothermic Machine Perfusion Device in Human Liver Transplantation
Recruiting
99 years or below
All
12 participants needed
1 Location
Brief description of study
The primary objective of the study is to assess the effect of preventing preservation-related graft injury with the use of the metra® device in enrolled subjects. The single-arm continued access phase will be used to collect additional effectiveness and safety data to support the objectives and outcomes of the original IDE pivotal study under IDE G140243. The secondary objectives include: To report graft and subject survival in enrolled subjects, to report evidence of post-reperfusion syndrome in enrolled subjects, to report biochemical liver function of all enrolled subjects, to report evidence of biliary complications in enrolled subjects, to assess the safety of the metra® device as a method of organ storage and transportation, to report organ utilization with NMP livers, to assess the health economic implications of normothermic liver perfusion and to report evidence of post-reperfusion ischemia-reperfusion injury following NMP. The primary outcome variable is to note severity of immediate graft injury as measured by early allograft dysfunction (EAD). The severity of immediate graft injury as measured by early allograft dysfunction (EAD) [40]. The continued access phase is non-randomized and therefore not powered. Descriptive statistics will be used to analyze the endpoint data. The secondary outcome variables include: Primary non-function rates: irreversible graft dysfunction requiring emergency liver replacement during the first 10 days after liver transplantation, graft survival rates at 30 days, 3 months, and 6 months following transplantation and subject survival rates at 30 days, 3 months, and 6 months following transplantation.
Eligibility of study
You may be eligible for this study if you meet the following criteria:
- Conditions: Medical Research
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Age: 99 years or below
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Gender: All
Updated on
12 Oct 2022.
Study ID: 849803