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临床试验/NCT07585890
NCT07585890招募中不适用

Establishing a Reference Framework for Outcomes After Machine-Preserved Liver Transplantation in Europe (REFRAME-MP)

University Medical Center Groningen14 个研究点 分布在 8 个国家目标入组 10,000 人开始时间: 2026年4月21日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
10,000
试验地点
14

研究概览

简要总结

Machine perfusion (MP) has become routine clinical practice in liver transplantation. However, as the field has matured, direct randomized comparisons between distinct MP modalities have become increasingly impractical, given that donor and graft characteristics often predetermine the optimal preservation strategy. Consequently, many studies continue to reference historical benchmark cohorts from the pre-perfusion era, or use risk scores developed before routine utilization of MP. These cohorts, while once valuable, fail to account for the paradigm shift that MP has introduced. Likewise, commonly used donor- and recipient-based risk scores were developed prior to the adoption of MP. While these scores aim to assess survival or morbidity after transplantation, none of them guide decisions about MP use or the most suitable perfusion protocol. As MP technologies continue to evolve there is a critical need for an updated reference framework that accurately reflects current clinical practice and captures the best achievable outcomes across all MP modalities.

详细描述

The aim of this study is to establish a reference framework for liver transplantation outcomes in the era of routine clinical machine perfusion. In addition, based on the collected real-world observational data, a target trial emulation approach will be applied.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • All postmortal livers accepted (transplanted and not-transplanted after machine perfusion) upon organ offer for patients >18 years at the time of liver transplantation.
  • All donor types (DBD, DCD)
  • Preservation either with static cold storage alone or combined with machine perfusion (MP).
  • Donor livers underwent MP as part of routine clinical practice and the choice of perfusion protocol was made according to institutional standard practice.
  • Eligible MP protocols are:
  • end-ischemic single- or dual hypothermic oxygenated MP [e(D)HOPE],
  • end-ischemic (back-to-base) normothermic MP [eNMP],
  • continuous (device-to-donor) normothermic MP [cNMP],
  • e(D)HOPE followed by controlled oxygenated rewarming and normothermic MP [e(D)HOPE-COR-NMP)],
  • e(D)HOPE followed by normothermic MP [e(D)HOPE-NMP], or
  • Normothermic regional perfusion followed by SCS or an ex situ MP protocol.
  • A minimum follow-up of 12 months after liver transplantation is required.

排除标准

  • Livers that were allocated to a MP protocol as part of a prospective randomized or interventional clinical trial comparing different preservation techniques or any other invention.
  • Living donor liver transplantation

研究者

申办方类型
Other
责任方
Sponsor

研究点 (14)

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