Thrombolysis Rate
Conditions
Keywords
Acute ischemic stroke, Electronic monitoring, Intravenous thrombolysis
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.
Interventions
BEHAVIORALMultilevel intervention
Multilevel intervention based on AACTT theory
Sponsors
Second Affiliated Hospital, School of Medicine, Zhejiang University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Door-to-image time | Up to 4.5 hours | The time between hospital arrival and the initiation of image |
| All-cause death rate | At 90 days | All-cause death rate at 90 days |
| Hemorrhagic transformation | At 7 days | the presence of hemorrhagic transformation is defined according to European Cooperative Acute Stroke Study (ECASS) II trial |
| 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 |
| 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) |
| 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) |
| 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) |
Other
| Measure | Time frame | Description |
|---|---|---|
| Door-to-needle time | Up to 4.5 hours | The time between hospital arrival and the initiation of IVT |
| Onset-to-needle time | Up to 24 hours | The time between the symptom onset and the initiation of IVT |
| the proportion of acute ischemic stroke patients with Door-to-Needle Time≤60min | Up to 4.5 hours | Difference between intervention arm and control arm in the percentage of patients receiving thrombolysis within 60 minutes of stroke onset |
Countries
China
Contacts
Primary ContactMin Lou, PhD
Outcome results
None listed