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临床试验/NCT01221142
NCT01221142Unknown3 期

Pilot Study of Hypothermia for Intracerebral Hemorrhage in Croatia

University of Rijeka2 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2011年1月最近更新:
适应症

试验速览

阶段
3 期
入组人数
20
试验地点
2
主要终点
Neurological outcome

研究概览

简要总结

In this pilot study the researchers will investigate efficacy of hypothermia in the early stage of treatment patients with primary intracerebral hemorrhage.

详细描述

The purpose of this pilot trial is to determine whether hypothermia improves neurological outcome (measured as 3 and 6 months after the onset of symptoms using mRS, GOS and BI) in patients who has suffered a primary intracerebral hemorrhage. The patients with primary intracerebral hemorrhage presented with coma (GCS ≤ 8) and ICH score 2-4 will be included. Induction of hypothermia will be initiated within 6 hours of symptoms onset. Patients will be cooled to core temperature of 34°C during 24 hours using non-invasive temperature management (Cincinnati Sub-Zero). The temperature will be measured continuously by esophageal system. After 24 hours of successful cooling, the target temperature will be gradually raised to achieve slow re-warming of 0.5°C / 2 h until the core temperature reaches 36,5°C.

During hypothermia ECG, blood pressure, oxygen saturation and intracranial pressure will be measured continuously and registered every 30 min. The first CT scan of the brain, after initial, will be done early after normothermia is reached.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
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

入选标准

  • ICH score 2-4
  • symptom onset within 6 hours
  • ages 18 - 80

排除标准

  • pregnancy
  • hemodynamical unstability
  • recent myocardial infarction
  • systolic blood pressure < 90 mm Hg

结局指标

主要结局

Neurological outcome

时间窗: 6 months after the onset

次要结局

  • Mortality(6 months)
  • The incidence of significant cardiac arrhythmias, infections, severe disturbances of electrolytes(3 days)

研究者

申办方类型
Other

研究点 (2)

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