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临床试验/NCT03815864
NCT03815864进行中(未招募)不适用

Role of Donor Specific Antibodies, Other Anti-human Leucocyte Antibodies and Autoantibodies in the Outcome of Liver Retransplantation

London Health Sciences Centre0 个研究点目标入组 200 人开始时间: 2019年1月24日最近更新:
适应症

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
200
主要终点
Retransplant graft survival

研究概览

简要总结

Despite reports that associate donor specific antibody (DSA) with rejection after liver transplantation, grafts are still allocated according to blood group (ABO) but not human leukocyte antigen (HLA) compatibility, possibly due to the absence of an easily discernible clinical association between adverse recipient outcome and DSA. Re-transplantation provides a test environment where the presence of preformed DSA or other antibodies is prevalent and events (graft loss) more common so that the effect of these antibodies on outcome should be apparent. This is an observational study of routine clinical care to determine these effects on our own patients. The goal is to perfect donor-recipient matching to attain the best outcome. In addition, we may develop hypotheses and potential treatments that would be tested in further clinical trials

详细描述

Despite reports that associate donor specific antibody (DSA) with rejection after liver transplantation, grafts are still allocated according to blood group (ABO) but not human leukocyte antigen (HLA) compatibility, possibly due to the absence of an easily discernible clinical association between adverse recipient outcome and DSA. Re-transplantation provides a test environment where the presence of preformed DSA or other antibodies is prevalent and events (graft loss) more common so that the effect of these antibodies on outcome should be apparent. This is an observational study of routine clinical care to determine these effects on our own patients.

In phase 1, we will examine the effect of antibodies specifically directed against the second donor in liver retransplantation. Other factors known to effect the outcome will be checked to allow for risk adjustment.

In phase 2, we will examine the role played by specific auto-antibodies such as angiotensin II receptor type 1 antibodies and endothelin-1 type A receptor antibodies on the outcome of liver retransplantation.

The goal of these observational study is to perfect donor-recipient matching to attain the best outcome. In addition, we may develop hypotheses and potential treatments that would be tested in further clinical trials.

研究设计

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

入排标准

性别
All
接受健康志愿者

入选标准

  • Recipients of a second liver transplantation performed at LHSC

排除标准

  • Recipients of ABO incompatible second liver transplantation
  • Recipients of multiple organs

结局指标

主要结局

Retransplant graft survival

时间窗: From date of transplantation until the date of next transplantation or date of death from any cause, whichever came first, assessed up to 240 months

Average length of time the second liver graft remains in a living recipient regardless of function

次要结局

  • Patient survival(From date of transplantation until the date of death from any cause assessed up to 240 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Vivian McAlister

Professor of Surgery

London Health Sciences Centre

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