NCT01836848Unknown不适用
Continuous, Non-invasive Monitoring of Cerebral Oxygenation and Perfusion Using Near-infrared Spectroscopy With Indocyanine Green Perfusion Measurement in Patients With Traumatic Brain Injury, Intracerebral or Subarachnoid Hemorrhage
适应症
试验速览
- 阶段
- 不适用
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- with near-infrared-spectroscopy detected cerebral perfusion deficit
研究概览
简要总结
The purpose of this study is to show if it is possible to detect secondary ischemic events in patients with severe brain injury or cerebral haemorrhage with the help of non-invasive near-infrared spectroscopy (NIRS) by using the indocyanine green measuring of cerebral perfusion.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients over 18 years
- •onset of clinical symptoms of subarachnoid or intracranial haemorrhage or trauma suffered less than 72h
- •indication for implanting a tissue oxygen and intracranial pressure probe
- •A signed informed consent by the patient or legal guardian
排除标准
- •Persistent epidural, subdural or subcutaneous hematoma in planned area of the NIRS optode
- •Open injuries in the area of the planned optodes
- •Malignant primary disease under chemotherapy
- •pregnancy
- •bleeding disorder
- •In the short term unfavorable prognosis (eg, bilateral wide and light-fixed pupils)
- •Patients with pacemakers or where no MRI compatibility is due to non- removable metal parts
- •contraindications for contrast media in CT (eg, iodine allergy)
- •Untreated hyperthyroidism
- •End Stage Renal Disease
- •severe psychomotor agitation
结局指标
主要结局
with near-infrared-spectroscopy detected cerebral perfusion deficit
时间窗: 15 days after ictus
次要结局
- Determining a threshold value for cerebral autoregulation measured with near-infrared-spectroscopy as a predictive value for the clinical outcome(15 days after ictus and follow up 6 month later)
研究者
Gerrit Brinker
senior physician
University of Cologne
研究点 (2)
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