Acute Anterior Circulation Large Vessel Occlusion Stroke.
Conditions
Interventions
Methylprednisolone Treatment Group:Intraoperative first recanalization followed by intra-arterial injection of Methylprednisolone (produced by *Mei Pharmaceutical Co., Ltd., 40mg) at a dose of 0.5mg/k
Saline Treatment Group:After the first recanalization during surgery, an equivalent volume of methylprednisolone placebo (saline) was injected through the arterial catheter and administered over 3-5 m
Sponsors
Xuzhou Mining Group General Hospital
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Age >= 18 years; 2. Time from symptom onset to randomization within 24 hours; 3. Anterior circulation LVO confirmed by clinical and imaging findings; 4. Baseline NIHSS >= 6; 5. Baseline ASPECTS >= 3; 6. Occlusion of intracranial ICA, MCA M1/M2 segment confirmed by CTA/MRA/DSA with mTICI >= 2b reperfusion and absence of severe operator-judged procedure-related complications; 7. Written informed consent from patient or legal representative.
Exclusion criteria
Exclusion criteria: 1. Premorbid mRS >= 2; 2. Pregnant or lactating female; 3. Hypersensitivity to glucocorticoids; 4. SBP > 185 mmHg or DBP > 110 mmHg uncontrolled by oral antihypertensives; 5. Inherited or acquired bleeding diathesis, anticoagulant deficiency, or oral anticoagulants with INR > 1.7; 6. Glucose 22.2 mmol/L; platelet count 220 µmol/L); 9. Life expectancy < 6 months due to comorbidities; 10. Unlikely to complete follow-up; 11. Intraoperative discovery of intracranial aneurysm or AVM; 12. Intraoperative findings prior to randomization: vascular perforation, severe dissection, or inability to administer IA therapy; 13. Brain tumor with mass effect on imaging; 14. Severe systemic infectious disease; 15. Participation in another clinical trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| All-cause mortality within 90±7 days after randomization;Symptomatic intracranial hemorrhage (sICH) within 72 h after randomization;Severe hyperglycemia within 72 h after randomization;Post-stroke pneumonia during the index hospitalization (up to 7 days);Gastrointestinal hemorrhage within 7 days after randomization;Ordinal distribution of the modified Rankin Scale (mRS) score at 90±7 days after randomization.(1)90-day favorable outcome (mRS 0–1); | — |
Secondary
| Measure | Time frame |
|---|---|
| 90-day favorable outcome (mRS 0–1);90-day functional independence (mRS 0–2);Final infarct volume on follow-up CT/MRI at 24–72 h.; | — |
Countries
China
Contacts
Public ContactWei Xiu E
Xuzhou Mining Group General Hospital
Outcome results
None listed