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

Not Applicable

Recruiting

• Conditions: Thrombolysis Rate
• Interventions: Behavioral: Multilevel intervention

• Registration Number: NCT05160610
• Lead Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-11-16
• Study First Submitted QC: 2021-12-06
• Study First Posted: 2021-12-16
• Study Start: 2022-01-01
• Status Verified: 2023-01
• Last Update Submitted: 2023-02-16
• Last Update Posted: 2023-02-17
• Primary Completion: 2023-03-31
• Study Completion: 2023-06-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 2720

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention group	Multilevel intervention	receiving multilevel intervention, electronic monitoring and stroke registry participation

Primary Outcome Measures

Name	Time	Method
Thrombolysis rate within 4.5 hours	Up to 4.5 hours	The proportion of acute ischemic stroke patients within 4.5 hours of onset

Secondary Outcome Measures

Name	Time	Method
Excellent neurological outcomes	At 90 days	Score of 0 to 1 on the modified Rankin Scale, on which scores range from 0 (no neurologic deficit) to 6 (death)
modified Rankin Scale score	At 90 days	The distribution of modified Rankin Scale score at 90 days, on which scores range from 0 (no neurologic deficit) to 6 (death)
Favorable neurological outcomes	At 90 days	Score of 0 to 1 on the modified Rankin Scale, on which scores range from 0 (no neurologic deficit) to 6 (death)
All-cause death rate	At 90 days	All-cause death rate at 90 days
Symptomatic intracranial hemorrhage	At 7 days	Intracranial hemorrhage at 24 hours associated with an increase of ≥4 points of NIHSS score from baseline, according to European Cooperative Acute Stroke Study (ECASS) II trial
Thrombolysis rate within 3 hours	Up to 3 hours	The proportion of acute ischemic stroke patients within 3 hours of onset
Hemorrhagic transformation	At 7 days	the presence of hemorrhagic transformation is defined according to European Cooperative Acute Stroke Study (ECASS) II trial
Door-to-image time	Up to 4.5 hours	The time between hospital arrival and the initiation of image

Trial Locations

Locations (1)

Second Affiliated Hospital, School of Medicine, Zhejiang University; 🇨🇳 Hangzhou, Zhejiang, China