Adacolumn®Standard Reperfusion TherapyStandard Medical Management
Adacolumn®: Adacolumn treatment :once a day for 4 consecutive days after enrollment (60 minutes each time, blood flow rate 30 mL/min, total blood volume processed 1800 mL); the treatment was performed by establishing extracorporeal circulation through bilateral arm veins, and a total of 4 adsorption treatments were completed.
Standard Reperfusion Therapy: Endovascular thrombectomy and/or intravenous thrombolysis will be performed in strict accordance with the indications, contraindications, and operational specifications outlined in the Chinese Stroke Society Guidelines for Reperfusion Therapy in Acute Ischemic Stroke (2024) and the latest official prescribing information for the relevant pharmaceuticals.
Standard Medical Management: Standard medical management for ischemic stroke.
Study summary
The primary objective is to investigate whether treatment with Adacolumn can ameliorate the progression of cerebral edema within 72 hours in patients with anterior circulation ischemic stroke. The secondary objective is to explore if Adacolumn could improve acute neurologic status, functional outcomes, treatment requirements and safety in patients with anterior circulation ischemic stroke.
Eligibility
Sex
ALL
Min age
18 Years
Max age
80 Years
Healthy volunteers
No
Inclusion Criteria:
1. Age 18-80 years, regardless of gender;
2. A clinical diagnosis of acute ischemic stroke;
3. 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;
4. NIHSS score ≥10 at screening;
5. Pre-stroke mRS score \<2 (independent in all activities of daily living);
6. 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);
7. 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;
8. Written informed consent obtained from the patient or legally authorized representative.
Exclusion Criteria:
1. Decompressive craniectomy performed before enrollment or between enrollment and initiation of study treatment;
2. 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);
3. 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.
4. 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;
5. Intracranial lesions conferring markedly increased bleeding risk (known brain tumor, arteriovenous malformation, aneurysm);
6. Inability to undergo MRI;
7. Absolute neutrophil count \<1.5×10⁹/L or \>15×10⁹/L
8. Absolute monocyte count \> 1.0 ×10⁹/L;
9. Red blood cells \<3.0×10¹²/L ;
10. Active internal bleeding or bleeding tendency (such as platelet count \<100×10⁹/L, INR \>1.7, PT \>15 seconds);
11. Marked hypercoagulability (fibrinogen \>700 mg/dL);
12. Intracranial or spinal surgery or severe head trauma within the past 3 months;
13. Refractory hypertension (persistent systolic blood pressure \>185 mmHg or diastolic \>110 mmHg);
14. Known allergy to components of the blood purification system (including adsorption membrane, anticoagulants);
15. 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);
16. Body temperature \>38°C or active infection;
17. Active autoimmune disease or immunodeficiency;
18. Participation in another interventional clinical trial within the past 30 days;
19. Any other condition deemed unsuitable for participation by the investigator.
Primary outcome measure(s)
The change in net water uptake (NWU) on CT between the immediate post-reperfusion and 72-78 hours post-reperfusion — 72 hours The change in net water uptake (NWU) measured on CT at 72-78 hours post-reperfusion, compared to the immediate post-reperfusion CT
Trial sites (1)
Facility
City
Region
Status
The Second Affiliated Hospital of Zhejiang University School of Medicine
Hangzhou
Zhejiang
More Second Affiliated Hospital, Zhejiang University, School of Medicine trials in China
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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