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

Официальное название

Efficacy and Safety of the Adacolumn® Granulocyte and Monocyte/Macrophage Apheresis Device for Cerebral Edema After Acute Anterior Circulation Occlusive Cerebral Infarction: A Prospective, Randomized, Controlled Clinical Trial

Обзор

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.

Подробное описание

This is a prospective, randomized, controlled trial evaluating Adacolumn therapy in patients with acute ischemic stroke due to anterior circulation large-artery occlusion presenting within 24 hours of stroke onset. Eligible patients who meet all inclusion and no exclusion criteria will be randomized in a 1:1 ratio to the Adacolumn group or the control group, with 5 patients enrolled in each arm (total n=10).

All participants will receive guideline-based standard reperfusion therapy (endovascular thrombectomy and/or intravenous thrombolysis, as appropriate) together with standard medical management. In the Adacolumn group, each patient will undergo four scheduled Adacolumn treatment sessions in addition to standard reperfusion and medical therapy. Patients in the control group will receive standard reperfusion therapy and standard medical treatment alone. Each participant will be followed for 90 days after enrollment.

The objective of the trial is to evaluate the effect of Adacolumn therapy on cerebral edema in patients with anterior circulation large-artery occlusion stroke. The primary endpoint is the change in net water uptake (NWU) measured on CT at 72-78 hours post reperfusion, compared to the immediate post-reperfusion CT.

Вмешательства

• Устройство 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.
• Процедура 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.
• Препарат Standard Medical Management
  Standard medical management for ischemic stroke.

Первичные конечные точки

• The change in net water uptake (NWU) on CT between the immediate post-reperfusion and 72-78 hours post-reperfusion [Срок оценки: 72 hours]

Вторичные конечные точки (12)

• Serious adverse events (SAEs) related to Adacolumn treatment (Primary Safety Outcome) [Срок оценки: Randomization to Day 90]
• The number of discontinuation of Adacolumn therapy due to adverse events (Safety Outcome) [Срок оценки: Randomization up to Day 3]
• The change in midline shift on CT between the immediate post-reperfusion and 72-78 hours post-reperfusion [Срок оценки: 72 hours]
• Change in National Institutes of Health Stroke Scale (NIHSS) score on day 7 post-treatment compared to immediate post-operative baseline [Срок оценки: Day 7]
• Number of participants who developed brain herniation after treatment [Срок оценки: Baseline up to Day 14]
• Number of participants who underwent decompressive craniectomy (DC) [Срок оценки: Baseline up to Day 14]
• modified Rankin Scale (mRS) Score [Срок оценки: Day 90]
• Number of participants who achieved mRS 0-2 [Срок оценки: Day 90]
• Number of participants who achieved mRS 0-3 [Срок оценки: Day 90]
• Number of participants with death [Срок оценки: Baseline up to Day 90]
• The relative percentage change in DWI edema volume at day 4 post-reperfusion compared to the immediate post-reperfusion DWI [Срок оценки: Day 4]
• The relative percentage change in DWI infarct volume at day 4 post-reperfusion compared to the immediate post-reperfusion DWI [Срок оценки: Day 4]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• The Second Affiliated Hospital of Zhejiang University School of Medicine — Ханчжоу

Публикации

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• Sheth KN, Petersen NH, Cheung K, Elm JJ, Hinson HE, Molyneaux BJ, Beslow LA, Sze GK, Simard JM, Kimberly WT. Long-Term Outcomes in Patients Aged </=70 Years With Intravenous Glyburide From the Phase II GAMES-RP Study of Large Hemispheric Infarction: An Exploratory Analysis. Stroke. 2018 Jun;49(6):1457-1463. doi: 10.1161/STROKEAHA.117.020365. Epub 2018 May 22. PMID 29789393
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Идентификаторы

NCT: NCT07386262 · 2025-1867

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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