Developing Viability Index for Machine Perfused Livers
追踪信息 | |||
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首次提交日期 ICMJE | September 26, 2018 | ||
首次发布日期e ICMJE | October 3, 2018 | ||
最后更新发布日期 | October 5, 2018 | ||
预计研究开始日期 ICMJE | October 1, 2018 | ||
预计主要完成日期 | October 1, 2021 (主要结果测量的最终数据收集日期) | ||
目前主要观察指标 ICMJE |
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 |
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原始主要观察测量 ICMJE | 与当前相同 | ||
目前的二级观察 ICMJE |
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描述性信息 | |||
简略标题 ICMJE | Developing Viability Index for Machine Perfused Livers | ||
正式标题 ICMJE | Development of a Liver Viability Index for Transplantation | ||
简要概况 | 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. |
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详细说明 | |||
研究类型 ICMJE | Interventional | ||
研究阶段 | N/A | ||
研究设计 ICMJE | 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 |
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适用条件 ICMJE | |||
干预项目 ICMJE |
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研究工具 |
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招募信息 | |||
招募状态 ICMJE | Not yet recruiting | ||
预计入组 ICMJE |
60 | ||
原始预计入组 ICMJE | 与当前相同 | ||
预计研究完成日期 | October 1, 2023 | ||
预计主要完成日期 | October 1, 2021 (主要结果测量的最终数据收集日期) | ||
合格标准 ICMJE | Inclusion Criteria: - Male or female 18-75 years of age. - Candidate for a deceased-donor liver allograft. Exclusion Criteria: - Seropositivity for HIV-1. | ||
性别 |
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年龄 | 最小年龄:18 Years ,最大年龄:75 Years | ||
接受健康的志愿者 | 没有 | ||
可入组国家 ICMJE | |||
管理信息 | 数据检测委员会 | No | |
研究涉及美国FDA监管的产品 |
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 |
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IPD 共享声明 |
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责任方 | Heidi Yeh,Massachusetts General Hospital | ||
研究赞助商 ICMJE | Massachusetts General Hospital | ||
合作者 ICMJE | |||
研究员 ICMJE |
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PRS 账户 | Massachusetts General Hospital | ||
验证日期 | 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 |