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临床试验/EUCTR2019-001542-17-FI
EUCTR2019-001542-17-FI进行中(未招募)1 期

Effect of xenon on brain injury, neurological outcome and survival in patients after aneurysmal subarachnoid hemorrhage - Xe-SAH

Timo Laitio0 个研究点目标入组 160 人开始时间: 2020年7月8日最近更新:
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试验速览

阶段
1 期
状态
进行中(未招募)
发起方
入组人数
160

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional clinical trial of medicinal product

入排标准

性别
All

入选标准

  • 1. Aneurysmal subarachnoid hemorrhage visible on CTA or DSA.
  • 2. Hunt-Hess 3-5
  • 3. Age of = 18 years
  • 4. Intubated.
  • 5. GCS 3–12 obtained off neuromuscular blocking agents
  • 6. Xenon treatment started within 6 hours after onset of SAH symptoms
  • Are the trial subjects under 18? no
  • Number of subjects for this age range:
  • F.1.2 Adults (18-64 years) yes
  • F.1.2.1 Number of subjects for this age range 140
  • F.1.3 Elderly (>=65 years) yes
  • F.1.3.1 Number of subjects for this age range 20

排除标准

  • 1.Acute traumatic brain injury
  • 2.Maximum diameter of intracerebral hemorrhage > 2.5 cm
  • 3.Pneumothorax or pneumomediastinum,
  • 4.Acute lung injury requiring = 60% FIO2 (fraction of inspired oxygen).
  • 5.Systolic arterial pressure < 80 mmHg or mean arterial pressure < 60 mmHg for over 30 min period
  • 6.Bilaterally fixed and dilated pupils
  • 7.Positive pregnancy test, known pregnancy, or current breast-feeding
  • 8.Chronic neurological deficiency due to chronic traumatic brain injury or other neurological illness
  • 9.Imminent death or current life-threatening disease
  • 10.Current enrollment in another interventional study
  • 11.The subject is known to have a clinically significant laboratory abnormality, medical condition (such as decompensated liver disease or severe chronic obstructive pulmonary disease), or social circumstance that, in the investigator’s opinion, makes it inappropriate for the subject to participate in this clinical trial.
  • 12.Presence of implants or foreign bodies which are not known to be MRI safe

研究者

发起方
Timo Laitio

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