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临床试验/NCT02515903
NCT02515903Unknown不适用

Comparison Between Stereotactic Aspiration and Intra-endoscopic Surgery to Treat Intracerebral Hemorrhage

Nanfang Hospital, Southern Medical University1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2015年5月最近更新:
适应症

试验速览

阶段
不适用
入组人数
100
试验地点
1
主要终点
Mortality rate

研究概览

简要总结

Views for surgery method selection of intracerebral hemorrhage are still controversial. Since the application of neuroendoscopic technique in intraventricular hemorrhage was confirmed effective and safe, some investigators have attempted to use endoscopic strategies to evacuate intracerebral hematomas. Some significant advances have also been reported in endoscopic hematoma evacuation when compared to conventional craniotomy. However, it is still crucial to implement a prospective and controlled study to evaluate the efficiency and safety of endoscopic technique in the treatment of intracerebral hemorrhage. In this study, the investigators will exclusively select some patients with intracerebral hemorrhage in the basal ganglia region. This study will compare the efficacy and safety of endoscopic surgery versus stereotactic aspiration on neurologic outcomes for patients with intracerebral hemorrhage.

详细描述

Although the incidence and mortality of spontaneous intracerebral hemorrhage (ICH) have been decreased with the improved management of high blood pressure, ICH may induce serious disability for the patients and continue to be a major socioeconomic problem. The evacuation of ICH using open craniotomy or computer tomography (CT)-guided stereotaxy may improve the survival rate of these patients but failed to prove efficacy in improving patients' functional outcome despite numerous efforts. Endoscopy-guided evacuation of ICH provides a less invasive and quicker surgical decompression, which may potentially improve the functional outcome for patients. In previous studies, endoscope-guided evacuation of ICH is often referred to as that an endoscope only provides an illuminating system while the operating channel is independent from the endoscope (endoscopy-controlled microneurosurgery or endoscopy-assisted microneurosurgery). In recent years, authors have been committed to explore the procedure of intra-endoscopy-guided evacuation of ICH, which means that the illuminating channel, the irrigation-aspiration channel and the working channel are all located in the endoscope. This kind of procedure can be called as real endoscopic neurosurgery (EN), which may potentially decrease the operative concomitant injuries at the most extent. However, the inherent drawbacks of intra-endoscopic procedures, including the limited visualization of the surgical field and the difficult maintenance of patency of the aspiration wand, can offset the advantages in some instances. The authors exclusively invented a special endoscopic transparent sheath for guiding hematoma puncture and an agitation-aspiration system (AAS) for keeping patency of the aspiration wand. Detailed procedures of their application will be implemented and verified in a series of patients with intracerebral hemorrhage. Meanwhile, the mortality rate, complications and other outcome parameters between this procedure and CT-guided procedures will be compared.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
18 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • primary basal ganglion region intracerebral hemorrhage
  • older than 18 years
  • admitted within 6 h after onset of ICH

排除标准

  • other type of ICH than acute primary intracerebral hemorrhage
  • patients who need neurosurgery
  • life expectancy less than 3 months due to comorbid disorders
  • confirmed malignant disease (cancer)
  • confirmed acute myocardial infarction
  • hepatitis and/liver cirrhosis
  • renal failure
  • infectious disease (HIV, endocarditis etc.)
  • current or previous hematologic disease
  • women of childbearing age if pregnant
  • participation in another study within the preceding 30 days

结局指标

主要结局

Mortality rate

时间窗: 90-day

all-cause motality rate within 90 days after the surgery

次要结局

  • operative time(24 h)
  • days of ICU stay(14 day)
  • Glasgow coma score(28 day)
  • intracranial infection(14 day)
  • In-hospital cost(28 day)
  • remnant blood in the hematoma after surgery(12 hour)
  • Glasgow outcome score(90-day)
  • rehemorrhage rate(3 day)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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