The Neuroendoscopic, Trans-occipital Approach Evacuation of Acute Hypertensive Cerebral Hemmorrhage Combined Low-drainage Surgery: a Multi-center Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 1,000
- 试验地点
- 1
- 主要终点
- Clinical remission rate
研究概览
简要总结
The Neuroendoscopic, Trans-occipital Approach Evacuation of Acute Hypertensive Cerebral Hemmorrhage Combined Low-drainage Surgery: a Multi-center Clinical Trial
详细描述
To evaluate the effect of different surgical approaches on the prognosis of patients with hypertensive intracerebral hemorrhage, hypertensive patients who met the diagnostic criteria of American guidelines for the treatment of adult spontaneous intracerebral hemorrhage (2015) were selected. The time from onset to admission was less than 8 hours. Blood routine examination, liver and kidney function, coagulation system, infectious diseases and other examinations were performed before operation, with emergency surgical indications, They were divided into two groups: transfrontal keyhole approach and transoccipital keyhole approach. Emergency endoscopic hematoma removal was performed. The patients were systematically evaluated and followed up at 1 week, 1 month, 3 months, 6 months and 12 months after operation to observe the improvement of consciousness, GCS score, postoperative rebleeding (appearance, bleeding volume, location, broken into ventricle, etc.), The prognosis was evaluated by ADL score, GCS score, gos score, modified Rankin scale, Mrs scale and ICH Score (GCS, hematoma volume, intraventricular hemorrhage, infratentorial source, patient age, etc.).
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
- None
入排标准
- 年龄范围
- 15 Years 至 75 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosed patients with spontaneous cerebral hemorrhage in the basal ganglia (in line with the diagnostic criteria of the American Adult Spontaneous Cerebral Hemorrhage Treatment Guidelines (2015)).
- •Head CT showed; hematoma volume ≥ 30ml, intraventricular hemorrhage is not counted as hemorrhage volume.
- •Time from onset to hospital admission ≤8h.
- •The age of the patient is 15-75 years old.
- •Glasgow Coma Score (GCS)> 5 points.
- •The patient/family knows and signs the informed consent form.
- •Have a clear history of hypertension in the past.
排除标准
- •Bleeding caused by aneurysm, vascular malformation or tumor stroke.
- •Combined with a history of head injury or trauma.
- •There is more blood in the skull.
- •Past mental disorders or neurological dysfunction.
- •A history of procoagulant dysfunction or anticoagulant drugs.
- •Patients with complications such as liver and kidney dysfunction.
- •Those with poor compliance.
- •Pregnant patients.
- •With massive hemorrhage of the ventricle (the area of the hematoma in the CT side is larger than 1/2 of the transverse section), hemorrhage in the third and fourth ventricles with enlarged ventricles.
- •With late-stage cerebral herniation (bilateral dilated pupils, central respiratory and circulatory failure).
- •Severe cardiovascular and cerebrovascular diseases: such as myocardial infarction, cerebral infarction, coronary heart disease, myocarditis, malignant arrhythmia, etc.
- •Participate in other clinical research 3 months before enrollment.
- •The doctor in charge believes that the study plan cannot be followed.
- •Those who are or plan to become pregnant or breastfeeding.
- •Those who are known to be allergic to test drugs or related products.
结局指标
主要结局
Clinical remission rate
时间窗: 1 month postoperation
The evaluation criteria of complete remission: more than 85% of intracranial hematoma was cleared, mild brain edema, and the postoperative hospital stay was less than 2 weeks. The evaluation criteria of partial remission: the clearance rate of intracranial hematoma was 60% - 85%, the postoperative brain edema was obvious, and the postoperative hospital stay was less than 4 weeks.
次要结局
未报告次要终点
研究者
Hou Lijun
Professor
Shanghai Changzheng Hospital