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临床试验/NCT05160610
NCT05160610招募中不适用

Improving Thrombolysis Implementation Based on Electronic Monitoring in Acute Ischemic Stroke (ITEM): a Cluster Randomized Controlled Trial

Second Affiliated Hospital, School of Medicine, Zhejiang University1 个研究点 分布在 1 个国家目标入组 2,720 人开始时间: 2022年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
2,720
试验地点
1
主要终点
Thrombolysis rate within 4.5 hours

研究概览

简要总结

A cluster randomized controlled trial will be conducted. Hospitals in Zhejiang Province, China, will be randomized into two arms (1:1): an intervention arm and a control arm.

Hospitals in the intervention arm will receive a multilevel intervention based on the AACTT theory, whereas hospitals in the control arm will receive no intervention and maintain routine care. All the hospitals will receive electronic monitoring. Hospitals with no stroke center or with <20 cases received thrombolysis per year will be excluded from the study.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
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

入选标准

  • Patients presented with clinical signs of acute ischemic stroke within 4.5 hours of stroke onset
  • Patient's age is >18 years

排除标准

  • Contraindication for intravenous thrombolysis

结局指标

主要结局

Thrombolysis rate within 4.5 hours

时间窗: Up to 4.5 hours

The proportion of acute ischemic stroke patients within 4.5 hours of onset

次要结局

  • Excellent neurological outcomes(At 90 days)
  • modified Rankin Scale score(At 90 days)
  • Favorable neurological outcomes(At 90 days)
  • All-cause death rate(At 90 days)
  • Symptomatic intracranial hemorrhage(At 7 days)
  • Thrombolysis rate within 3 hours(Up to 3 hours)
  • Hemorrhagic transformation(At 7 days)
  • Door-to-image time(Up to 4.5 hours)

研究者

发起方
Second Affiliated Hospital, School of Medicine, Zhejiang University
申办方类型
Other
责任方
Sponsor

研究点 (1)

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