Stereotactic Aspiration and Thrombolysis of Intracerebral Hemorrhage: a Prospective Controlled Study（SATIH）
试验速览
- 阶段
- 不适用
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- The rate of rebleeding and mortality, Glasgow Outcome Scale for prognosis
研究概览
简要总结
The purpose of this study is to evaluate the superiority of effect of the modified micro-invasive aspiration and drainage and conservative medical therapy in the treatment of ICH spontaneously hypertensive scientifically.
详细描述
The stereotactic computed tomographic-guided aspiration and drainage is one of the best choices in the treatment of a large-scale deep supratentorial intracerebral hematoma. It uses hardware access technology, in a relatively short time to enter the hematoma center, with suction liquefaction technology. It has the advantage of a higher clearance rate of the hematoma, simple convenience, small trauma and low-cost. We carry on the suitable improvement in this technology's foundation in view of its deficiency, the introduction of the concept of the individual, will further reduce the rate of bleeding and mortality, improve survival, such as long-term quality of life.
We will adopt scales such as the rate of rebleeding, mortality, complication,NIHSS, MRS, BI, GOS scale to analysis and evaluating efficacy and safety of this technology and conservative treatment in the treatment of HICH.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Investigator)
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
- •CT diagnosis of spontaneous supratentorial intracerebral hemorrhage, the amount of bleeding more than 50 ml, and had neurological signs
- •All income groups the incidence of medical records to be random, the time should be < 69 hours to ensure that within 72 hours of the onset of the operation
- •To be random, former GCS score > = 5 points
- •Systolic blood pressure <= 200 mmHg, mean arterial pressure <= 150 mmHg (if higher than this value, but as corresponding to this standard can be dealt with the group, and only reached the standard before they can ask for random)
- •Fasting plasma glucose <= 11.1 mmol / L (if higher than this value, but as corresponding to this standard can be dealt with the group, and only reached the standard before they can ask for random)
- •Patients aged 18 to 80-year-old.
- •Based on China's relevant laws, the patient himself or family members (only in patients with the loss of his ability to judge the acts of circumstances) agreed to participate in this study, a good compliance, to fully comply with random, in accordance with the decision by the treatment, patients himself Or family members must sign informed consent moreover.
- •Patients themselves or their families (only in patients with the loss of his ability to judge the acts of circumstances) have willingness and ability to follow the research program, data collection and preservation of history and follow-up process of informed consent.
排除标准
- •Patients clotting mechanisms are obstacles or having the experience of the use of anticoagulant drug (PT> 15s, APTT> 40s, INR> 1.4, platelet count <100 × 10 9 / L).
- •Cerebral hernia formed more than two hours
- •The merger of other serious system failure (heart, liver and kidney, etc.) or a variety of end-stage disease with cerebral hematoma (such as renal failure late cerebral hemorrhage, blood disease with cerebral hemorrhage)
- •Prior to the onset of a variety of reasons for the defect or neurological movement disorder
- •A clear cause of cerebral hemorrhage such as intracranial aneurysm, or dynamic
- •such as a venous malformation
- •Intracranial or serious systemic infection
- •Marked cognitive impairment or mental abnormality
- •Other such as pregnancy, cancer
研究组 & 干预措施
1
To position haematoma's location, drills several millimeter holes in the localization point of puncture, then insert the drainage tube to inhale haematoma, gives the filament resolver interrupted for liquefication drainage afterward.
干预措施: YL-1 type of intracranial hematoma puncture needle (Device)
2
In the treatment, under the convention we use the dehydrator for patients, the ultra early patient may use anti-filament medicinal preparation 6- amino-caproic acid 6-12g/d, intravenous drip, the period of revolution does not surpass for 24 hours, then just right for the illness treatment.
干预措施: dehydrating agent, haemostatic (Drug)
结局指标
主要结局
The rate of rebleeding and mortality, Glasgow Outcome Scale for prognosis
时间窗: duration of 14 days after operation(rebleeding), duration of hospital stay(mortality), 180 days after onset(mortality and GOS)
次要结局
- Nation of Health Stroke Scale Score , modified Rankin Scale, Barthel Index complications(the moment of admission and post operation(NIHSS), 14 days after admission(NIHSS,MRS), duration of hospital stay(complications), 180 days after onset(BI, MRS))