A Trial of Adacolumn on Cerebral Edema After Anterior Circulation Ischemic Stroke

Ki vehet részt

• Age 18-80 years, regardless of gender
• A clinical diagnosis of acute ischemic stroke
• Proven large vessel occlusion in ICA or MCA-M1 occlusion (carotid occlusions can be cervical or intracranial, with or without tandem MCA lesions) determined by MRA or CTA or DSA
• NIHSS score ≥10 at screening
• Pre-stroke mRS score <2 (independent in all activities of daily living)
• Time from stroke onset to initiation of the first Adacolumn treatment is ≤24 hours, stroke onset is defined as the last time the patient was known to be at their neurological baseline (wake-up strokes qualify if within this time window)
• All endovascular thrombectomy and/or intravenous thrombolysis must strictly adhere to the "2024 Chinese Stroke Association Guidelines for Reperfusion Therapy in Acute Ischemic Stroke" and the latest prescribing information regarding indications, contraindications, and procedural standards
• Written informed consent obtained from the patient or legally authorized representative

Ki nem vehet részt

• Intracranial or spinal surgery or severe head trauma within the past 3 months
• After endovascular thrombectomy: extensive contrast extravasation (diffuse subarachnoid high density or parenchymal high density not consistent with hematoma), new subarachnoid hemorrhage（SAH）, or symptomatic intracranial hemorrhage (sICH)
• Intracranial lesions conferring markedly increased bleeding risk (known brain tumor, arteriovenous malformation, aneurysm)
• Refractory hypertension (persistent systolic blood pressure >185 mmHg or diastolic >110 mmHg)
• Known allergy to components of the blood purification system (including adsorption membrane, anticoagulants)
• Body temperature >38°C or active infection
• Active autoimmune disease or immunodeficiency
• Any other condition deemed unsuitable for participation by the investigator
• Absolute neutrophil count <1.5×10⁹/L or >15×10⁹/L
• Absolute monocyte count > 1.0 ×10⁹/L
• Red blood cells <3.0×10¹²/L
• Active internal bleeding or bleeding tendency (such as platelet count <100×10⁹/L, INR >1.7, PT >15 seconds)
• Marked hypercoagulability (fibrinogen >700 mg/dL)
• Acute ST-segment elevation myocardial infarction and/or acute decompensated heart failure and/or corrected QT interval >520 ms and/or history of cardiac arrest within the past 6 months(pulseless electrical activity, ventricular tachycardia, ventricular fibrillation, or asystole)
• Decompressive craniectomy performed before enrollment or between enrollment and initiation of study treatment
• Large-vessel occlusion is attributed to other determined etiologies per TOAST classification, such as tumor-related, dissection-related, or other clearly identifiable non-LAA/non-CE causes
• Clinical signs of brain herniation, such as unilateral or bilateral fixed dilated pupils and/or other loss of brainstem reflexes attributable to cerebral edema or herniation in the investigator's opinion
• Inability to undergo MRI
• Participation in another interventional clinical trial within the past 30 days