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Clinical Trials/NCT05160610
NCT05160610
Recruiting
Not Applicable

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 site in 1 country2,720 target enrollmentJanuary 1, 2022
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ConditionsThrombolysis Rate

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Thrombolysis Rate
Sponsor
Second Affiliated Hospital, School of Medicine, Zhejiang University
Enrollment
2720
Locations
1
Primary Endpoint
Thrombolysis rate within 4.5 hours
Status
Recruiting
Last Updated
3 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSitesSimilar Trials

Overview

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.

Registry
clinicaltrials.gov
Start Date
January 1, 2022
End Date
June 30, 2023
Last Updated
3 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Second Affiliated Hospital, School of Medicine, Zhejiang University
Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

  • •Contraindication for intravenous thrombolysis

Outcomes

Primary Outcomes

Thrombolysis rate within 4.5 hours

Time Frame: Up to 4.5 hours

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

Secondary Outcomes

  • 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)

Study Sites (1)

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