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

Starting soon · Not applicable

Conditions studied: Cerebral Edema, Ischemic Stroke, Acute, Malignant Cerebral Edema, Anterior Circulation Brain Infarction

In brief

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.

Key facts

Study ID

NCT07386262

Run by

Second Affiliated Hospital, Zhejiang University, School of Medicine

People needed

10

Starts

2026-08-10

Expected to finish

2028-12-31

Last updated by the study team

2026-08-07

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• Decompressive craniectomy performed before enrollment or between enrollment and initiation of study treatment;
• 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);
• 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;
• Intracranial lesions conferring markedly increased bleeding risk (known brain tumor, arteriovenous malformation, aneurysm);
• Inability to undergo MRI;
• 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);
• Intracranial or spinal surgery or severe head trauma within the past 3 months;
• 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);
• 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);
• Body temperature >38°C or active infection;
• Active autoimmune disease or immunodeficiency;
• Participation in another interventional clinical trial within the past 30 days;
• Any other condition deemed unsuitable for participation by the investigator.

Where it is running

• The Second Affiliated Hospital of Zhejiang University School of Medicine — Hangzhou, Zhejiang, China

Full record on ClinicalTrials.gov

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