Sivelestat Sodium as an Adjunct to Endovascular Thrombectomy for Acute Anterior Circulation Large-Vessel Occlusion

Korábbi kezelés

• 7．Systolic blood pressure >185 mmHg or diastolic blood pressure >110 mmHg that cannot be controlled with antihypertensive therapy;
• 21．Current treatment with chemotherapy or other immunomodulatory agents (e.g., recombinant human granulocyte colony-stimulating factor, Xuebijing, or ulinastatin);

Más betegség

• 2．Failure to obtain a baseline NIHSS score before sedation or intubation by a neurologist or emergency physician;
• 3．Seizure at stroke onset that precludes assessment of the baseline NIHSS score;
• 6．Severe allergy or absolute contraindication to iodinated contrast agents;
• 15．Evidence of intracranial tumor (except small meningioma), acute intracranial hemorrhage, tumor, or arteriovenous malformation;
• 18．Neurological disease or psychiatric disorder that may interfere with evaluation of the patient's condition;
• 20．Confirmed rheumatic or autoimmune disease with long-term use of immunosuppressants or corticosteroids;
• 23．Any other condition that, in the opinion of the investigator, would make the patient unsuitable for participation or may pose a significant risk to the patient.

Laborértékek

• 5．Known allergy to sivelestat sodium or any of its excipients;
• 8．Blood glucose <50 mg/dL (2.8 mmol/L) or >400 mg/dL (22.2 mmol/L);
• 9．Platelet count <50 * 10⁹/L;
• 10．Hereditary or acquired bleeding tendency, coagulation factor deficiency, current oral anticoagulant use with INR >1.7, or oral anticoagulant treatment within the previous 48 hours;
• 11．Severe renal failure, defined as serum creatinine >3.0 mg/dL (265.2 μmol/L), glomerular filtration rate (GFR) <30 mL/min, or requirement for hemodialysis or peritoneal dialysis;

Egyéb

• 1．Simultaneous acute occlusion of both the anterior and posterior circulation, or bilateral acute large-vessel occlusion in the anterior circulation;
• 4．Bilateral dilated pupils;
• 12．Inability to complete the 90-day follow-up (e.g., no fixed residence or overseas patients);
• 13．Suspected vasculitis or septic embolism;
• 14．Suspected aortic dissection;
• 16．Significant mass effect with midline shift;
• 17．Evidence of internal carotid artery dissection causing flow limitation;
• 19．Pregnant or breastfeeding women;
• 22．Participation in another clinical trial that may interfere with the results of this study;

• 1.Symptoms and signs consistent with focal ischemia in the anterior circulation;
• 2.Large vessel occlusion of the anterior circulation (internal carotid artery, M1/M2 segment of the middle cerebral artery) confirmed by CTA/MRA/DSA;
• 3.Undergoing mechanical thrombectomy;
• 4.Age between 18-80 years, both male and female;
• 5.Pre-stroke modified Rankin Scale (mRS) score ≤1;
• 6.Time from symptom onset to thrombectomy ≤24 hours, including wake-up stroke or unwitnessed stroke; symptom onset is defined as the "last known well" (LKW);
• 7.National Institutes of Health Stroke Scale (NIHSS) score ≥6 at admission;
• 8.ASPECTS ≥3 for anterior circulation occlusion;
• 9.Written informed consent provided by the patient or their legal representative.