Improving Thrombolysis Implementation Based on Electronic Monitoring in Acute Ischemic Stroke (ITEM)

Zhejiang University

Status: Enrolling

Conditions: Thrombolysis Rate

Treatments: Behavioral: Multilevel intervention

Study type: Interventional

Funder types: Other

Identifiers

NCT05160610

ITEM

Details and patient eligibility

About

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.

Enrollment: 2,720 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

Contraindication for intravenous thrombolysis

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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2,720 participants in 2 patient groups

Intervention group

Experimental group

Description:

receiving multilevel intervention, electronic monitoring and stroke registry participation

Treatment:

Behavioral: Multilevel intervention

Control group

No Intervention group

Description:

receiving routine care , electronic monitoring and stroke registry participation