The Preliminary Efficacy and Safety of Intra-Arterial Albumin as Adjunct to Mechanical Thrombectomy in Acute Ischemic Stroke：Dual-Center, Prospective, Open-Label, Endpoint-Blinded, Randomized Controlled Clinical Trial
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 60
- 主要终点
- Growth in infarct volume at 24 (±6) hours after randomization compared to baseline
研究概览
简要总结
Albumin-assisted therapy has demonstrated good safety and potential neuroprotective effects following mechanical thrombectomy. To further systematically evaluate its efficacy and safety, we are conducting a Phase IIa clinical trial of intra-arterial albumin administration combined with mechanical thrombectomy in patients with acute ischemic stroke. This is a double-center, prospective, open-label, endpoint-blinded, randomized controlled trial designed to preliminarily assess the efficacy and safety of intra-arterial infusion of 20% human albumin after successful recanalization in patients with acute ischemic stroke caused by anterior circulation large-vessel occlusion who undergo mechanical thrombectomy. A total of 60 patients will be enrolled and randomized in a 1:1 ratio by dynamic minimization into two groups: the albumin group (0.6 g/kg of 20% human albumin solution plus mechanical thrombectomy) and the control group (mechanical thrombectomy alone).
The primary objective of this study is to preliminarily evaluate whether intra-arterial infusion of 0.6 g/kg of 20% human albumin via the internal carotid artery immediately after achieving successful recanalization (eTICI ≥ 2b) can reduce infarct volume compared with mechanical thrombectomy alone in patients with anterior circulation large-vessel occlusion who undergo standard mechanical thrombectomy. The secondary objective is to assess the safety and feasibility of intra-arterial infusion of 0.6 g/kg of 20% human albumin immediately after successful recanalization in this patient population.
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)
盲法说明
independent Imaging Core Laboratory
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •1.Age ≥ 18 years; 2.ICA or MCA-M1 occlusion, confirmed by preoperative CTA/MRA/DSA. ICA occlusion can be cervical or intracranial, with or without tandem MCA lesions; Treated with EVT resulting in recanalization ((expanded Thrombolysis in Cerebral Infarction [eTICI] 2b-3); 3.Baseline NIHSS scores ≥ 6; 4.Baseline ASPECTS ≥6 on non-contrast CT; 5.The time from stroke onset/last seen well to arterial puncture is within 24 hours; 6.No significant pre-stroke disability (pre-stroke mRS ≤2); 7.Signed informed consent from the patient or the legally authorized representative
排除标准
- •1.Presence of intracranial hemorrhage on head CT or MRI； 2.Midline shift with significant mass effect on head CT or MRI； 3.History of heart failure or severe cardiovascular disease, including but not limited to pulmonary hypertension, pericardial effusion, etc； 4.Arrhythmia accompanied by hemodynamic instability； 5.Symptoms or electrocardiographic evidence of acute myocardial infarction upon admission； 6.Acute or chronic renal failure (serum creatinine >2.0 mg/dL)； 7.Severe anemia (hematocrit <32%)； 8.Known allergy to albumin or blood products； 9.Pregnant women； 10.Persistent blood pressure ≥180/100 mmHg prior to albumin infusion； 11.Concurrent participation in another clinical trial； 12.Life expectancy of less than 3 months； 13.Coexisting severe pulmonary diseases such as Chronic Obstructive Pulmonary Disease, pulmonary fibrosis, pleural effusion, pulmonary hypertension, or acute respiratory distress syndrome； 14.Any other condition that, in the opinion of the investigator, makes the patient unsuitable for participation in this study.
研究组 & 干预措施
Albumin Group
Subjects assigned to the albumin treatment group after achieving successful recanalization (eTICI ≥ 2b) confirmed by DSA post-thrombectomy will receive a 20% human albumin solution at a dose of 0.60 g/kg. The solution will be administered as a constant-rate infusion into the proximal internal carotid artery over 20 minutes. Vital signs and potential infusion-related reactions must be closely monitored throughout the procedure.
干预措施: Human serum albumin infusion 20% (Drug)
结局指标
主要结局
Growth in infarct volume at 24 (±6) hours after randomization compared to baseline
时间窗: at 24 (±6) hours after randomization
MRI-DWI
次要结局
- Proportion of favorable functional outcome at 90 (±14) days, defined as mRS 0-2(at 90 (±14) day after randomizatio)
- Infarct volume at 24 (±6) hours(at 24 (±6) hours after randomization)
- Proportion of excellent functional at 90 (±14) days, defined as mRS 0-1(at 90 (±14) day after randomization)
- mRS score at 90 (±14) days(at 90 (±14) days after randomization)
- Vessel recanalization at 24 (±6) hours(at 24 (±6) hours after randomization)
- NIHSS score at 24 (±6) hours(at 24 (±6) hours after randomization)
- NIHSS score at 7 (±1) days/at discharge(at 7 (±1) days/at discharge after randomization)
- EQ-5D-5L at 90 (±14) days(at 90 (±14) days after randomization)
- Proportion of Barthel Index ≥95 at 90 (±14) days(at 90 (±14) days after randomization)
- Incidence of all-cause death within 90 (±14) days(at 90 (±14) days after randomization)
- Incidence of symptomatic intracranial hemorrhage within 24 (±6) hours(at 24 (±6) hours after randomization)
- Incidence of intracranial hemorrhage within 24 (±6) hours(at 24 (±6) hours after randomization)
- Incidence of serious adverse events within 90 (±14) days(at 90 (±14) days after randomization)
- Incidence of adverse events within 90 (±14) days(at 90 (±14) days after randomization)
- Proportion of early neurological deterioration at 24 hours(at 24 hours after randomization)
- Proportion of severe disability at 90 (±14) days(at 90 (±14) days after randomization)
- Incidence of albumin infusion-associated adverse event within 24 (± 6) hours(at 24 (± 6) hours after randomization)
研究者
Ming Wei
PhD
Tianjin Huanhu Hospital