Intravenous ThrombolysisRegistry for Acute Ischemic Stroke in China
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- 试验地点
- 1
- 主要终点
- mRS of 90 days after thrombolysis
研究概览
简要总结
To analyze the real situation of intravenous thrombolysis in acute ischemic stroke in China
详细描述
Compare the efficacy and safety of different thrombolytic drugs; Analysis of patients during hospital treatment of adverse events and complications; Analysis of factors that affect the effectiveness of treatment; Evaluate the pharmacological benefits of different thrombolytic drugs
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •age> 18 years old;
- •meet the diagnostic criteria of China 2014 guidelines for the diagnosis and treatment of acute ischemic stroke;
- •no history of first sepsis or previous cerebral infarction sequelae (mRS ≤ 1);
- •within 3 hours of onset;
- •Have measurable neurological deficits;
- •Patients or legal guardians can understand and sign informed consent.
排除标准
- •Absolute exclusion criteria:
- •history of head trauma or stroke within the last 3 months;
- •suspected subarachnoid hemorrhage;
- •history of previous intracranial hemorrhage;
- •intracranial tumor, arteriovenous malformation or aneurysm ;
- •recent intracranial or intraspinal surgery;
- •arterial puncture at an incurable site within the last 7 days;
- •elevated blood pressure: systolic blood pressure ≥180 mm Hg, or diastolic blood pressure ≥100 mm Hg;
- •Internal bleeding;
- •acute bleeding tendency, including platelet count less than 100 × 109 / L or other conditions;
- •heparin treatment within 48 h (APTT is outside the upper limit of normal range);
- •oral anticoagulant, INR> 1.7 Or PT> 15S;
- •are currently using thrombin inhibitors or factor Xa inhibitors, various sensitive laboratory abnormalities (such as APTT, INR, platelet count, ECT; TT or appropriate factor Xa activity assays) ;
- •Blood glucose <50 mg / dl (2.7 mmol / L);
- •CT suggestive of multiple cerebral infarction (low density range> 1/3 of the cerebral hemispheres) ;
- •Other conditions considered unsuitable for inclusion in this clinical study;
- •3 months or are participating in other clinical trials;
- •combined with severe systemic disease is expected to survive less than three months.
- •Relative exclusion criteria:
- •severe stroke (NIHSS> 25 points);
- •pregnancy;
- •neurological deficits after epileptic seizures;
- •major surgery or severe trauma within the last 14 days;
- •Urethral hemorrhage;
- •Myocardial infarction within the last 3 months;
研究组 & 干预措施
Alteplase group
According to 0.6-0.9mg / kg alteplase (maximum can not exceed 90mg), of which 10% intravenous injection, the remaining 60 minutes intravenous infusion
干预措施: Alteplase (Drug)
Urokinase group
1.2-1.5 million U dissolved in 100ml sodium chloride injection, 30 minutes intravenously End
干预措施: Urokinase (Drug)
结局指标
主要结局
mRS of 90 days after thrombolysis
时间窗: Month 3
Proportion of patients with mRS = 0-1 points 90 days after thrombolysis
次要结局
- Evaluation of Adverse events(Year 1)
研究者
Hui-Sheng Chen
Neurology Chief
General Hospital of Shenyang Military Region