Background
Methods
Aim of the trial
Study description and study design
Arms and intervention
Eligibility criteria
Inclusion criteria: | |
1. | Suspected acute stroke according to the dispatcher stroke identification algorithm [8] during MSU hours and within the MSU catchment area |
2. | Age ≥ 18 years |
Inclusion criteria for the primary study population: | |
3. | Final diagnosis of ischemic stroke (ICD-10: I63) or TIA (G45 except G45.4) |
4. | Pre-stroke mRS ≤ 3 (able to ambulate without assistance) |
5. | Confirmed onset-to-alarm time ≤ 4 h |
Exclusion criteria: | |
1. | Symptom remission until arrival of MSU or regular ambulancea |
2. | Malignant or other severe primary disease with life expectancy < 1 year |
Exclusion criteria for the primary study population: | |
3. | Major surgery within last 4 weeks |
4. | Confirmed stroke within last 3 months |
5. | Absolute contraindication for both thrombolysis and endovascular treatment |
Outcome measures
Primary outcome measure: | |
1. | Primary outcome: assessment of functional outcome over the entire range of the mRS |
2. | Co-primary outcome: assessment of functional outcome including the following range of outcomes: mRS 0–3 if available, mRS 4–5 or (if mRS is missing) living in institution (information according registration office at 4 months after stroke), and death |
Secondary outcome measures: | |
1. | Thrombolysis rate |
2. | Endovascular thrombectomy rate |
3. | Onset-to-treatment time |
4. | Onset-to-reperfusion time (for endovascular thrombectomy, Charité centers only) |
5. | Alarm-to-imaging time |
6. | Alarm-to-treatment time |
7. | Imaging-to-treatment time |
8. | Cost effectiveness (additional costs due to implementation and running of STEMO, duration of hospital stay regarding acute treatment and rehabilitation, hospital related costs, costs of long-term care, and combination of above mentioned) |
9. | Quality of life (EQ-5D) |
10. | Shift analyses for mRS ≤ 1 at 3 months in patients ≤80 years of age living at home without disability and mRS ≤ 2 at 3 months in patients > 80 years of age living at home with help or living in an institution |
11. | Secondary ICH after thrombolysis or thrombectomy |
12. | Symptomatic secondary ICH according to the discharge letter |
13. | In-hospital mortality |
14. | Death rate over time (Kaplan-Meier plot) |
15. | Discharge status (including in-hospital mortality among patients not included in the primary study population, especially patients with ICH) |
16. | Functional outcome among patients with ICH |
17. | Rate of emergency medical service deliveries to specialized facilities (patients with large vessel occlusion to endovascular thrombectomy capable facility, patients with ICH to neurosurgery department) |