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Developing Viability Index for Machine Perfused Livers

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合作者:
信息的提供 (责任方):
Heidi Yeh,Massachusetts General Hospital
September 26, 2018
October 3, 2018
October 5, 2018
October 1, 2018
October 1, 2021   (主要结果测量的最终数据收集日期)
Peak transaminase value post transplant[ Time Frame: 1 Year ]
The primary endpoint is peak transaminase values since transaminase elevation is a marker of hepatocyte injury

与当前相同
  • Acute Liver Rejection[ Time Frame: 1 Year ]
  • Incidence of major Infection[ Time Frame: 1 Year ]
  • Hepatitis C Recurrence (in Hepatitis C positive recipients)[ Time Frame: 1 Year ]
  • Kidney Failure[ Time Frame: 1 Year ]
  • Biliary Complications[ Time Frame: 1 Year ]
  • Liver Graft Failure[ Time Frame: 1 Year ]
  • Death[ Time Frame: 1 Year ]
 
Developing Viability Index for Machine Perfused Livers
Development of a Liver Viability Index for Transplantation

Machine perfusion technology is nearing the point of rescuing discarded liver grafts in the hope of proving them to be or improving them to the point of being transplantable. However, there are no validated metrics to determine transplantability after machine perfusion. This study involves collecting biopsies from transplanted livers before and after implantation to correlate metabolite and gene expression with post-transplant function. This data will help develop a viability index for machine perfused livers.

Interventional
N/A
分配:
干预模型: Single Group Assignment
干预模型描述:
盲法: Interventional
盲法描述:
主要目的: Diagnostic
  • Diagnostic Test: Liver Biopsy
    For measurement of tissue co-factor levels, we will take needle biopsies of transplanted livers immediately after procurement, immediately prior to implantation (at the end of preservation), 30 minutes after portal vein reperfusion, and 30 minutes after hepatic artery reperfusion. For those livers that have more than 60 minutes between portal vein and hepatic artery reperfusion, an additional biopsy will be performed at 60 minutes after portal vein reperfusion. Post-procurement biopsies will be collected regardless of where the liver was obtained.
  • Experimental: Biopsy
    Biopsies taken at protocol specified time points
 
Not yet recruiting
60
与当前相同
October 1, 2023
October 1, 2021   (主要结果测量的最终数据收集日期)
Inclusion Criteria: - Male or female 18-75 years of age. - Candidate for a deceased-donor liver allograft. Exclusion Criteria: - Seropositivity for HIV-1.
参与研究的性别: All
最小年龄:18 Years ,最大年龄:75 Years  
没有
 
No
研究美国FDA监管的药品: No
研究涉及美国FDA监管的设备产品: No
计划分享 IPD: No
Heidi Yeh,Massachusetts General Hospital
Massachusetts General Hospital
:
Massachusetts General Hospital
October 2018

ICMJE     国际医学期刊编辑委员会和 世界卫生组织 ICTRP 要求的元素
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