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临床试验/NCT01434056
NCT01434056Unknown不适用

Prediction of Mortality in Patients Waiting for Liver Transplantation Through Brain Magnetic Resonance Imaging

Hospital Israelita Albert Einstein1 个研究点 分布在 1 个国家目标入组 400 人开始时间: 2011年11月最近更新:
适应症

试验速览

阶段
不适用
入组人数
400
试验地点
1
主要终点
Mortality

研究概览

简要总结

The purpose of this study is to determine whether hepatic encephalopathy, measured through magnetic resonance imaging, electroencephalogram and neuropsychological evaluation adds prognostic information to patients who are waiting for liver transplantation. If this model improves mortality prediction this might be used in the future for organ allocation.

详细描述

The only current definitive treatment for end-stage liver disease is transplantation. Due to the scarcity of organs available, the correct prioritization of patients for liver transplantation has a crucial importance. Nowadays, patients are ranked according to severity of liver disease, measured by the MELD score. This index is only derived from objective measures (serum concentration of bilirubin, creatinine and INR). Hepatic encephalopathy (HE) is a serious and progressive disorder in patients with end-stage liver disease. The severity of HE has prognostic implications in those waiting for liver transplantation. However, the prognosis of HE is independent and not correlated to the MELD score. Hepatic encephalopathy triggers multiple changes in brain magnetic resonance imaging (MRI) providing an objective way to evaluate it. Also electroencephalogram and neuropsychological evaluation might increase mortality prediction.

Adding the information provided by MRI, electroencephalogram and neuropsychological evaluation to the MELD score model might increase the prediction of mortality. Increase mortality's prediction has a fundamental importance because in organ allocation.

We will evaluate the predictive value of these variables in predicting mortality of those patients waiting for liver transplantation.

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

  • Man or woman over 18 years old
  • Listed in liver transplantation waiting line
  • Patient able and willing to participate in the evaluations of this study

排除标准

  • Acute liver failure
  • Serious structural brain anomalies
  • Condition or situation in which, in the opinion of the investigator, put the patient at significant risk

结局指标

主要结局

Mortality

时间窗: Three months

次要结局

未报告次要终点

研究者

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

Ellison Fernando Cardoso

MD, PhD

Hospital Israelita Albert Einstein

研究点 (1)

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