NCT03578107已完成不适用
Improve Acute Reperfusion Treatment Quality for Stroke in China
Beijing Tiantan Hospital1 个研究点 分布在 1 个国家目标入组 15,895 人开始时间: 2018年7月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 15,895
- 试验地点
- 1
- 主要终点
- The adherence rate of guidelines for IV-tPA and/or endovascular treatment in eligible patients.
研究概览
简要总结
In order to bridge the great gaps, Chinese Stroke Association (CSA) and American Heart Association (AHA) sought to develop, conduct, and assess a multifaceted quality improvement intervention to increase the adherent rate of IV tPA and ET and improve 3-month clinical outcomes for these patients through our cluster-randomized stepped-wedge IMPROVE: Stroke in China trial.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Hospitals from CSCA.
- •Secondary or tertiary public hospitals with an emergency department and neurologic wards that receive patients with AIS.
- •Have a 24*7 on-call stroke team.
- •Have the capacity of IV rt-PA thrombolytic therapy or/and endovascular treatment.
- •Implement at least 10 patients' rt-PA or/and endovascular treatment during the last year.
- •Admit at least 5 patients of acute ischemic stroke within 24 hours after onset each month.
- •Have full desire to improve the procedure of treatment of acute ischemic stroke.
- •Have good cooperation among Neurology department, Emergency department, Interventional department, Neurosurgery department, Laboratory and Radiology department.
- •Patients： Patients who are ≥18 years old were eligible for inclusion if they presented with acute ischemic stroke diagnosed by CT and/or MRI and arrived at hospital within 6 hours after symptom onset.
排除标准
- •Hospitals that can not comply with the protocol and finish the research.
- •Grade-one hospitals and non cerebral vascular disease specialized hospitals.
- •Hospitals involved in other stroke care quality improvement projects or relevant clinical trials.
- •1）Patients refuse to participate in this study
结局指标
主要结局
The adherence rate of guidelines for IV-tPA and/or endovascular treatment in eligible patients.
时间窗: participants will be followed for the duration of hospital stay, an expected average of 2 weeks
次要结局
- in-hospital mortality(participants will be followed for the duration of hospital stay, an expected average of 2 weeks)
- 3-month disability（mRS≥3 ）(patients will be followed up at 3 months)
- proportional change of intravenous thrombolytic therapy in eligible patients 4.5h after the onset(participants will be followed for the duration of hospital stay, an expected average of 2 weeks)
- proportional change of endovascular treatment in eligible patients 6h after the onset(participants will be followed for the duration of hospital stay, an expected average of 2 weeks)
- door-to-puncture time(participants will be followed for the duration of hospital stay, an expected average of 2 weeks)
- time from arrival to hospitals to intravenous thrombolytic therapy(participants will be followed for the duration of hospital stay, an expected average of 2 weeks)
研究者
Yongjun Wang
Executive Vice-President
Beijing Tiantan Hospital
研究点 (1)
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