跳至主要内容
临床试验/NCT03371264
NCT03371264已完成不适用

Optimizing Donor-recipient Matching to Improve Survival After Registration on the Waiting List for Liver Transplantation: the OPTIMATCH LT Study

Assistance Publique - Hôpitaux de Paris0 个研究点目标入组 9,000 人开始时间: 2015年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
9,000
主要终点
Decision tree analysis

研究概览

简要总结

A major limitation of liver transplantation is organ shortage. To avoid exposing patients to death on the waiting list, organs are used that would have been discarded few years ago. Graft allocation is regulated by the "agence de biomedecine" which establishes a national score. Each liver graft is proposed to the patient presenting the higher score. Acceptance or rejection of the graft only depends on the decision of each centre. We propose to submit a more efficient allocation model (enabling each proposed liver graft to be transplanted in the candidate whose transplantation will afford the greatest survival benefit after registration), by collecting and analysing variables from donors and candidates/recipients.

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

  • Liver transplant candidates : All adult LT candidates listed on the French wait list between 2009 and 2014 and followed prospectively by the mean yearly follow-up under the control of ABM.
  • Donors : all adults donors registered over the same 2009-2014 period, including donors whose livers were procured and transplanted, whose liver were procured and discarded, and donors in whom liver was not harvested.

排除标准

  • Pediatric recipients
  • Pediatric donors

结局指标

主要结局

Decision tree analysis

时间窗: 5 years

In view of the complexity of our project, different parallel approaches will be performed in order to establish predictive models

Survival analysis

时间窗: 5 years

In view of the complexity of our project, different parallel approaches will be performed in order to establish predictive models

Multi-state models

时间窗: 5 years

In view of the complexity of our project, different parallel approaches will be performed in order to establish predictive models

次要结局

  • drop-outs for worsening (Candidate population)(5 years)
  • number of ECD criteria (Donor population)(5 years)
  • graft failure (Donor population)(5 years)
  • deaths on the waiting list (Candidate population)(5 years)
  • Number of each criterion of ECD (Donor population)(5 years)
  • Percentage of each criterion of ECD (Donor population)(5 years)
  • epidemiological characteristics (Candidate population)(5 years)
  • indication for transplantation (Candidate population)(5 years)
  • number of drop-outs for improvement (Candidate population)(5 years)
  • mean score (Donor population)(5 years)
  • frequency of ECD criteria (Donor population)(5 years)
  • mean age of donors (Donor population)(5 years)
  • grafts with correct primary function (Donor population)(5 years)
  • Proportion of early deaths after transplantation (Candidate population)(5 years)
  • median time of occurrence (Candidate population)(5 years)
  • Donor scores (DRI, ELTR) (Donor population)(5 years)
  • severity of disease (Candidate population)(5 years)
  • comorbidities (Candidate population)(5 years)
  • time on waiting list (Candidate population)(5 years)
  • percentages of drop-outs for improvement (Candidate population)(5 years)

研究者

申办方类型
Other
责任方
Sponsor

相似试验

Data Collection Study From Donors and Recipients to... | 临床试验