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临床试验/NCT02451046
NCT02451046Unknown不适用

Predictive Ability of Alpha-GST to Detect Graft Primary Dysfunction After Liver Transplantation

Beaujon Hospital1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2014年3月最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
100
试验地点
1
主要终点
Primary dysfunction (PDF) of liver graft

研究概览

简要总结

The primary objective of this study was to evaluate the ability of plasma alpha-GST measurements in liver donor (at the time of organ removal) to predict primary dysfunction in liver recipient. The secondary objective was to study the relationship between alpha-GST levels in the plasma of the liver transplant recipient and early graft function recovery.

详细描述

Graft primary dysfunction (PDF) after liver transplantation is enhanced by the increasing use of extended-criteria allografts. This complication is burdened with high mortality and morbidity rates among liver transplant recipients. Alpha-GST is a short-life hepatocyte enzyme that may be an interesting biomarker for liver injury. A recently developped ELISA technique may allow fast and easy measurement of alpha-GST plasma concentration (Fastpack IP α-GST Immunoassay, Qualigen Inc., Carlsbad, CA). This study aims to evaluate the ability of plasma alpha-GST measurements in liver donor to predict PDF in liver recipient. Methods: Observational study conducted in one center (Beaujon hospital, APHP, Clichy, France). Measurements of plasma levels of alpha-GST using Fastpack IP α-GST Immunoassay (Qualigen Inc., Carlsbad, CA) at the time of organ removal in liver donor and daily from day 0 to day 7 after liver transplantation in recipients.

研究设计

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

入排标准

年龄范围
18 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • age > 18 years
  • undergoing liver transplantation at Beaujon hospital (APHP, Clichy, France )

排除标准

  • age >70 years and <18 years

结局指标

主要结局

Primary dysfunction (PDF) of liver graft

时间窗: First week

To evaluate the ability of plasma alpha-GST measurements in liver donor (at the time of organ removal) to PDF in liver recipient.

次要结局

  • Early graft function recovery.(First week)

研究者

发起方
Beaujon Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Paugam-Burtz

Professor

Beaujon Hospital

研究点 (1)

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