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临床试验/NCT03275883
NCT03275883已完成不适用

Retrospective Analysis to Identify Independent Predictive Risk Factors for Early and Late Arterial Occlusion in Liver Transplantation and Compare Short and Long-term Outcomes for Aorto-hepatic Conduits in Liver Transplantation

University of Zurich1 个研究点 分布在 1 个国家目标入组 567 人开始时间: 2017年9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
567
试验地点
1
主要终点
Placement sites

研究概览

简要总结

The aim of this study is to determine the risk profile of hepatic artery occlusion in liver transplant recipients who received an aortohepatic conduits, analyzing all consecutive cadaveric liver transplantations from July 2007 to 31st December 2016. Medical records will be examined and adverse events will be analyzed and categorized using the Clavien-Dindo classification and Comprehensive Complication Index.

详细描述

BACKGROUND

Arterial conduits in liver transplantation are almost as old as the procedure itself. First described by Starzl in 1984, the knowledge remains superficial. Although rarely performed, there is no doubt that thousands of patients' lives were saved because of the use of arterial grafts. However, arterial grafts are known to be associated with a higher rate of occlusion and a lower patient and graft survival when compared to conventional end-to-end anastomosis. In our recent retrospective study, the investigators showed that retransplantation procedure and aspirin in patients' medication are independent risk factors for the need of an arterial conduit. The investigators assume that aspirin could be a surrogate marker for vascular and metabolic status. Furthermore, in a meta-analysis the investigators found a four times higher occlusion rate compared to non-conduits.

Whether the site of conduit placement or certain types of material have an impact on occlusion and graft survival remains unknown. In addition, several studies discuss that antiaggregation or anticoagulation might be protective for occlusion of arterial conduits. Currently, there is no study that investigated this problem, most probably because of low case numbers.

STUDY OBJECTIVES

The primary goal of this study is to conduct a multicenter cohort analysis to define the outcome of different types of conduits and to investigate whether antiplatelet / anticoagulantion has an impact on patency rates.

研究设计

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

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 transplantation requiring aorto-hepatic or iliac-hepatic conduits
  • Deceased donor after brain death (DBD) or deceased donor after circulatory death (DCD)
  • Whole organ as well as split allografts
  • Primary liver transplantation as well as liver retransplantation
  • Recipient age ≥18 years

排除标准

  • Living donor liver transplantation
  • Pediatric liver transplantation (recipient age <18 years)
  • Arterial reconstruction other than aorto-hepatic or iliac-hepatic conduits
  • Multivisceral transplantations

结局指标

主要结局

Placement sites

时间窗: June 2007 til 31st December 2016

To compare different placement sites (infrarenal, supraceliac, iliacal, etc.) of arterial conduits in terms of occlusion rates and graft survival

Patency Rates

时间窗: June 2007 til 31st December 2016

To investigate whether antiplatelet therapy is protective in terms of arterial patency.

Independent risk factors

时间窗: June 2007 til 31st December 2016

To identify independent risk factors for early and late occlusion of arterial conduits in liver transplantation.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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