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

Korábbi kezelés

• Intracranial or spinal surgery or severe head trauma within the past 3 months;

Más betegség

• 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.

Laborértékek

• 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);

Egyéb

• 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;

• 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.