Ischemic Stroke
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. Aged 18-80 years; 2.Time from symptom onset to randomization =6; 5. ASPECTS <6 core ; 6. Underwent endovascular therapy achieving eTICI 2b-3 reperfusion; 7. Written informed consent obtained from patient or legal guardian.
Exclusion criteria
Exclusion criteria: 1.Pregnancy or lactation confirmed, or positive pregnancy test prior to randomization; 2. Documented severe contrast allergy (excluding mild rash reactions); 3. Refractory hypertension uncontrolled by medication (persistent SBP >185 mmHg or DBP >110 mmHg); Note: Patients may be enrolled if antihypertensives successfully maintain BP within acceptable thresholds; 4. Hemorrhagic diathesis meeting any criteria: Platelet count =35 seconds; Warfarin use with INR >1.7;Direct thrombin/Xa inhibitor use within 48h (apixaban, rivaroxaban, dabigatran, etc.);Exception: No routine coagulation testing required for patients without coagulopathy history/suspicion. 5. Major organ surgery/biopsy within past 1 month; 6. Active bleeding (e.g., gastrointestinal, genitourinary) within past 1 month; 7. Current hemodialysis/peritoneal dialysis; severe renal insufficiency (GFR 220 µmol/L) 8. History of intracranial/subarachnoid hemorrhage or space-occupying brain tumors; 9. Life expectancy <3 months (e.g., advanced malignancy, severe cardiopulmonary disease); 10. Concurrent enrollment in other interventional trials affecting outcome assessment; 11. Investigator-determined ineligibility (e.g., psychiatric/cognitive impairments compromising protocol adherence); 12. Radiological evidence of midline shift/heralding cerebral herniation signs; 13. Intracranial hemorrhage confirmed on imaging; 14. Acute bilateral strokes or multivessel occlusion involving multiple territories; 15. Anatomical constraints precluding head elevation protocol.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 90d mRS ordinal shift; | — |
Secondary
| Measure | Time frame |
|---|---|
| The proportion of 90-day mRS Scores 0-2;The proportion of 90-day mRS Scores 0-3;Proportion of subjects with NIHSS reduction >=4 points at D7/discharge;Incidence of aspiration pneumonia within 72 hours;Incidence of symptomatic intracranial hemorrhage within 36 hours;All-cause mortality at 90days;Probability of any intracranial hemorrhage within 36 hours ;Rate of decompressive craniectomy during hospitalization; | — |
Countries
China
Contacts
Baotou Central Hospital