The Feasibility and Outcome of Intravenous Thrombolysis for Stroke Patients in the 3-4.5 Hour Time Window in China
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 200
- 主要终点
- National Institute of Health Stroke Scale score and modified Rankin Scale
研究概览
简要总结
The time window for intravenous recombinant tissue plasminogen activator treatment in ischemic stroke patients has been extended to 4.5h. Little is known about intravenous recombinant tissue plasminogen activator use in the 3-4.5 hour time window among Chinese stroke patients. This exploratory study was to describe the feasibility and outcome of treatment with intravenous recombinant tissue plasminogen activator in the expanded time window, and to offer suggestions for future clinical work in China.
详细描述
Favorable clinical outcome of intravenous recombinant tissue plasminogen activator was assessed by absolute changes in the National Institute of Health Stroke Scale score at 24 hours and by the improvement of modified Rankin Scale score at discharge or 6-month follow-up. The safety of intravenous recombinant tissue plasminogen activator was assessed by the rate of mortality, intracerebral hemorrhage and other common complications. Multivariate logistic regression models were used to evaluate factors associated with favorable clinical outcome.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 40 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •stroke patients in the 3-4.5 hour time window -
排除标准
- •stroke patients in more than 4.5 hour time window
研究组 & 干预措施
recombinant tissue plasminogen activator
Stroke patients with rt-PA treatment in the 3-4.5 hour time window were compared with those within 3h.
干预措施: IV rt-PA (Drug)
rt-PA
One group of was treated with standard recombinant tissue plasminogen activator therapy in 3h and the other group of stroke patients was treated within 3-4.5h.
干预措施: IV rt-PA (Drug)
结局指标
主要结局
National Institute of Health Stroke Scale score and modified Rankin Scale
时间窗: Outcome measure will be assessed at 24 weeks
Favorable clinical outcome of intravenous recombinant tissue plasminogen activator was assessed by absolute changes in the National Institute of Health Stroke Scale score at 24 hours and by the improvement of modified Rankin Scale score at discharge or 6-month follow-up
次要结局
未报告次要终点
研究者
zhipeng xu
Wuhan General Hospital of Guangzhou Military Command
Wuhan General Hospital of Guangzhou Military Command