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临床试验/NCT02045407
NCT02045407已完成不适用

Computed Tomography Angiography Accuracy in Brain Death Diagnosis

Sergio Brasil, MD MSc1 个研究点 分布在 1 个国家目标入组 106 人开始时间: 2014年1月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
106
试验地点
1
主要终点
Assess the presence or absence of contrast medium filling of the intracranial vessels in comatose patients.

研究概览

简要总结

The purpose of this study is to assess the reliability of computed tomography angiography (CTA) to diagnose brain death, face of several conditions that make impossible to define such diagnosis using clinical criteria exclusively.

详细描述

Critically ill patients, presenting Glasgow Coma Score 5 or lower, will be submitted to the Computed Tomography Angiography (CTA) of the skull assessment, and follow a clinical evaluation for brain death, additionally, transcranial Doppler would be applied as the gold standard for brain death.

We will exclude patients whose do not can be submitted to contrast injection, or if a brain death clinical evaluation has been performed prior the CTA.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

入排标准

性别
All
接受健康志愿者

入选标准

  • Individuals of any age or sex with brain death suspicion raised, before clinical test.
  • Comatose patients presenting Glasgow Coma Score as or under 5 points, under sedative agents or not.

排除标准

  • Brain dead patients clinically confirmed.
  • Contraindications to the use of contrast medium (renal failure or allergy).

结局指标

主要结局

Assess the presence or absence of contrast medium filling of the intracranial vessels in comatose patients.

时间窗: 1 year

After excluding confounding factors, we will submit comatose patients to CTA. Immediately after the exam, we will perform clinical evaluation for brain death and calculate CTA sensibility and specificity for this diagnosis. Time between these two interventions will be measured.

次要结局

未报告次要终点

研究者

发起方
Sergio Brasil, MD MSc
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Sergio Brasil, MD MSc

MD

University of Sao Paulo

研究点 (1)

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