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临床试验/NCT02894034
NCT02894034Unknown不适用

Is the Measured Diameter of the Optic Nerve Sheath by Cerebral Scan in Patients With Early Phase Meningeal Hemorrhage Due to a Ruptured Aneurysm a Prognostic 6-month Mortality Factor?

Centre Hospitalier Universitaire, Amiens2 个研究点 分布在 1 个国家目标入组 114 人开始时间: 2013年8月19日最近更新:
适应症

试验速览

阶段
不适用
入组人数
114
试验地点
2
主要终点
patient survival

研究概览

简要总结

Sub Arachnoid Hemorrhage (SAH) is a public health concern because of its high incidence (7/100 000 inhab.), its mortality rate (25%), and its morbidity rate (50%).

详细描述

Sub Arachnoid Hemorrhage (SAH) is a public health concern because of its high incidence (7/100 000 inhab.), its mortality rate (25%), and its morbidity rate (50%).

Prognostic tools are indispensable in guiding and optimizing the care of these patients.

Some diagnostic factors have been identified (e.g. age, comorbidities, ACSOS , GCS, ICP, occurrence of complications) as well as some classification schemes used for grading seriousness of the disease (Hunt and Hess, World Federation of NeuroSurgery).

A tool that is simple, reliable, reproducible, non costly, non invasive, and simple to perform (including remote methods and without changing planned patient care) would be ideal.

The measurement of the Optic Nerve Sheath Diameter (ONSD,) correlated by MRI and ultrasound in previous studies, with intra-cranial pressure (ICP: a fundamental prognostic factor for SAH) could be one of these tools.

研究设计

研究类型
Observational
观察模型
Case Only
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

  • Patients 18 years or older
  • Patient admitted to the Neurosurgical Urgent Care Unit for SAH following a ruptured aneurysm
  • Patients or one of their loved ones providing written informed consent
  • Patients with healthcare coverage

排除标准

  • Unavailability of a CTc in the initial phase (within the first 12 hours) or absence of 1-mm slices from the scan
  • Trauma to the optic globe or optic nerve pathology
  • Preexisting anomalies of ICP or history of neurosurgical cerebral pathologies
  • SAH of non aneurysm origin (e.g. arterio-venous malformation (AVM), tumor, trauma, sepsis)
  • Patients under legal protection

结局指标

主要结局

patient survival

时间窗: month 6

patient survival

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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