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临床试验/NCT01537263
NCT01537263Unknown不适用

Ultrasound Perfusion Imaging After Aneurysmal Subarachnoid Hemorrhage

Asklepios Kliniken Hamburg GmbH1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2012年1月最近更新:
适应症

试验速览

阶段
不适用
入组人数
30
试验地点
1
主要终点
Change of perfusion

研究概览

简要总结

The purpose of this study is to examine wether delayed cerebral ischemia can be predicted by ultrasound brain perfusion imaging in patients with aneurysmal subarachnoid hemorrhage (SAH).

详细描述

The delayed cerebral ischemia is a main complication in patient with aneurysmal subarachnoid hemorrhage which causes neurological deficit. So far there is no reliable diagnostic tool to predict the appearance of cerebral ischemia.

The causal correlation between presence of cerebral vasospasm measured daily by transcranial Doppler sonography (TCD) and occurrence of cerebral ischemia detected by cranial computed tomography scan (CCT) is not finally verified.

First studies demonstrated that ultrasound perfusion imaging (UPI) allows the detection of perfusion deficits in middle cerebral artery infarction.

The purpose of our study is to evaluate the diagnostic and prognostic value of UPI to predict delayed cerebral ischemia. In our trial we compare parameters of UPI (b= rise rate, A= plateau of acoustic intensity) in patients with aneurysmal subarachnoid hemorrhage with results of follow-up cranial computed tomography scans (CCT), TCD results and clinical outcome.

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

  • Aneurysmal subarachnoid hemorrhage, Hunt and Hess 0-5
  • Informed consent
  • Sufficient transtemporal acoustic window
  • First examination within 48h after subarachnoid hemorrhage
  • Minimum Age 18 years

排除标准

  • Contraindication against computed tomographic scan
  • Incompatibility against SonoVue™
  • Acute respiratory distress syndrome
  • Uncontrollable hypertensive crisis
  • Severe pulmonary disease(pulmonary hypertension > 90 mmHg)
  • acute severe cardiac insufficiency (New York Heart Association IV)
  • known right-left-shunt
  • pregnancy and breastfeeding
  • Substance dependence

结局指标

主要结局

Change of perfusion

时间窗: Baseline, Day 5

Detection of hypoperfusion (defined by 50% or more reduction in beta-value of comparing day 1. with day 5.) in one or more of four regions in one or both hemispheres before the detection of delayed ischemia after SAH in CCT.

次要结局

  • Change of Perfusion(Baseline, Day 5)
  • Correlation between perfusion parameters, clinical course and flow velocities(Day 1 to 90)

研究者

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

Gunter Seidel, MD

MD, Professor of Neurology

Asklepios Kliniken Hamburg GmbH

研究点 (1)

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