AIS
Conditions
Interventions
Intervention group:Immediate intravenous thrombolysis and synchronous transportation at primary medical institutions
Control group:First transfer to county-level hospital followed by routine management
Sponsors
Shanghai East Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 85 Years
Inclusion criteria
Inclusion criteria: 1. Aged 18–85 years (inclusive); 2. Clinically suspected acute stroke: FAST score >=2, including unilateral upper or lower limb weakness; suspected or confirmed acute ischemic stroke by CT in township medical institutions; 3. Time from onset or last known well = 4; 5. Written informed consent has been signed (by the patient or legal representative);
Exclusion criteria
Exclusion criteria: 1.Intracranial hemorrhage demonstrated by CT (parenchymal, intraventricular, subarachnoid hemorrhage, subdural/epidural hematoma, etc.); 2.Known bleeding tendency or severe coagulopathy: platelet count 1.7 or PT > 15 s; novel oral anticoagulants within 48 hours; active visceral bleeding / bleeding diathesis, or significant hemorrhagic disease within the past 6 months, or other bleeding risks; 3.Previous history of intracranial hemorrhage; severe head trauma or stroke within the past 3 months; 4.Intracranial tumor, giant intracranial aneurysm; 5.Intracranial / intraspinal surgery within the past 3 months; major surgery within the past 2 weeks; arterial puncture at a non-compressible site within the past 7 days; 6.Gastrointestinal or urinary tract hemorrhage within the past 3 weeks; 7.High clinical suspicion of aortic arch dissection; 8.Irreversible severe hypertension: SBP > 185 mmHg or DBP > 110 mmHg despite treatment; 9.Blood glucose 1/3 middle cerebral artery territory); 11.Severe stroke with NIHSS score > 25; 12.Stroke onset accompanied by seizure, and the main symptoms are judged clinically more consistent with post-ictal state; 13.Pregnancy or lactation; 14.Any terminal disease with life expectancy = 3 months; 15.Pre-stroke mRS score > 2; 16.Any other physical conditions that, in the investigator’s judgment, may be unfavorable for the patient to participate in the study; 17.Currently participating in other clinical trials of drugs or devices;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Patients' 90-day independence rate (mRS 0–2); | — |
Secondary
| Measure | Time frame |
|---|---|
| Incidence of symptomatic intracranial hemorrhage (sICH);90-day all-cause mortality; | — |
Countries
China
Contacts
Public ContactGang Li
Shanghai East Hospital
Outcome results
None listed