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
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- The change in net water uptake (NWU) on CT between the immediate post-reperfusion and 72-78 hours post-reperfusion
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Standard Treatment
Conventional Reperfusion and Medical Therapy
干预措施: Standard Reperfusion Therapy (Procedure)
Standard Treatment
Conventional Reperfusion and Medical Therapy
干预措施: Standard Medical Management (Drug)
Device: Adacolumn®
Adacolumn Treatment Combined with Conventional Reperfusion and Medical Therapy.
干预措施: Standard Reperfusion Therapy (Procedure)
Device: Adacolumn®
Adacolumn Treatment Combined with Conventional Reperfusion and Medical Therapy.
干预措施: Standard Medical Management (Drug)
Device: Adacolumn®
Adacolumn Treatment Combined with Conventional Reperfusion and Medical Therapy.
干预措施: Adacolumn® (Device)
结局指标
主要结局
The change in net water uptake (NWU) on CT between the immediate post-reperfusion and 72-78 hours post-reperfusion
时间窗: 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
次要结局
- Serious adverse events (SAEs) related to Adacolumn treatment (Primary Safety Outcome)(Randomization to Day 90)
- The number of discontinuation of Adacolumn therapy due to adverse events (Safety Outcome)(Randomization up to Day 3)
- The change in midline shift on CT between the immediate post-reperfusion and 72-78 hours post-reperfusion(72 hours)
- Change in National Institutes of Health Stroke Scale (NIHSS) score on day 7 post-treatment compared to immediate post-operative baseline(Day 7)
- Number of participants who developed brain herniation after treatment(Baseline up to Day 14)
- Number of participants who underwent decompressive craniectomy (DC)(Baseline up to Day 14)
- modified Rankin Scale (mRS) Score(Day 90)
- Number of participants who achieved mRS 0-2(Day 90)
- Number of participants who achieved mRS 0-3(Day 90)
- Number of participants with death(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(Day 4)
- The relative percentage change in DWI infarct volume at day 4 post-reperfusion compared to the immediate post-reperfusion DWI(Day 4)