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临床试验/NCT03396016
NCT03396016进行中(未招募)不适用

Plasmatic Factor V as a Predictor of Graft Dysfunction After Liver Transplantation

University Health Network, Toronto1 个研究点 分布在 1 个国家目标入组 140 人开始时间: 2018年4月18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
140
试验地点
1
主要终点
Factor V plasma level

研究概览

简要总结

Factor V is a coagulation cofactor that is primarily produced by the liver. Previous data has suggested a correlation between factor V levels and graft dysfunction. The investigators hypothesize that Factor V may be a reliable biomarker for hepatic function after LT. Therefore, the aim of this study is to validate the use of Factor V as a predictor of graft dysfunction after LT. This is a single-center prospective validation study. Patients undergoing LT at the University Health Network will have plasmatic Factor V levels measured during postoperative week 1. Patients will be followed up to 12 months. The study outcomes will be early graft dysfunction, and graft and patient survival. Graft loss will be defined as need for retransplantation in the study period.

详细描述

There is no widely accepted biomarker to assess hepatic function after Liver Transplantation (LT). Factor V is a coagulation cofactor that is primarily produced by the liver. Factor V has a short half-life and its production does not depend on vitamin K, relying mainly on liver function. These singular characteristics make Factor V plasmatic levels strictly linked to liver function. Previous data has suggested a correlation between factor V levels and graft dysfunction. The investigators hypothesize that Factor V may predict graft dysfunction after LT, and become a reliable biomarker for hepatic function after LT. Therefore, the aim is to validate the use of Factor V as a predictor of graft dysfunction after LT. This is a single-center prospective validation study. Participants (patients undergoing LT at the University Health Network) will have plasmatic Factor V levels measured on postoperative days (POD) 1º, 2º, 3º, 5º and 7º. Participants will be followed up to 12 months. The study primary outcome will be early graft dysfunction as defined by Olthoff et al. Secondary outcomes will be 3-, 6- and 12-months graft and patient survival. Graft loss will be defined as need for retransplantation in the study period. Potential confounders will be assessed in a multivariate regression model. No other intervention will be done to the patients. The results of this study may validate the use of this biomarker for graft dysfunction and mortality after LT. These results will impact LT research and direct patient care.

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 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Listed for a deceased donor liver transplant at University Health Network
  • Able and willing to provide informed consent

排除标准

  • Patients unable to provide informed consent
  • Recipients of live donor liver transplantation
  • Re-transplants
  • Recipients of multiple organs

结局指标

主要结局

Factor V plasma level

时间窗: Day 5

Factor V plasma level

次要结局

  • Graft survival(12 months)
  • Patient survival(12 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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