Albumin for Patients With Acute Large Vessel Occlusive Stroke Undergoing Endovascular Therapy -2
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 1,192
- 试验地点
- 56
- 主要终点
- Proportion of patients with mRS 0-2 or return to baseline mRS (if the baseline premorbid mRS =3-4) at 90 days.
研究概览
简要总结
This study is a prospective, multicenter, open-label, randomized controlled clinical trial. The investigators will apply albumin to the reperfusion treatment of patients with acute ischemic stroke in the anterior circulation. This study aims to verify the efficacy and safety of albumin combined with endovascular treatment in patients with anterior circulation acute ischemic stroke.
详细描述
This study investigates the application of albumin in reperfusion therapy for patients with acute ischemic stroke in the anterior circulation. Patients who met all inclusion criteria and none of the exclusion criteria will be randomly assigned in a 1:1 ratio to either the Albumin combined with Endovascular Therapy group or the Endovascular Therapy group. All subjects in both groups received acute stroke treatment and secondary prevention therapy according to current American stroke guidelines, aside from our intervention. At baseline, subjects underwent non-contrast cranial computed tomography (CT) or magnetic resonance angiography (MRA) to identify the occlusion site and presence of hemorrhage; relevant laboratory tests and mRS, NIHSS, and ASPECTS scores were also completed. Furthermore, vital signs were recorded. A 90-day post-randomization telephone follow-up was conducted to assess patients using several quality of life scales.
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
- None
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 between 18 and 80 years;
- •Acute ischemic stroke with indications for endovascular treatment within 24 hours of onset;
- •Anterior circulation acute ischemic stroke, with acute occlusion of the responsible vessel located in the intracranial segment of the internal carotid artery, or the M1 or M2 segment of the middle cerebral artery;
- •National Institute of Health Stroke Scale (NIHSS) score >=6;
- •Alberta Stroke Program Early CT Score (ASPECTS) >=3 points;
- •Modified Rankin Scale (mRS) score ≤4 before onset of the disease;
- •Written informed consent provided by the patients or their legal relatives.
排除标准
- •Evidence of intracranial hemorrhage (intracerebral hematoma (ICH), subarachnoid hemorrhage (SAH), epidural hemorrhage, acute or chronic subdural hematoma (SDH)) on the baseline CT or MRI scan;
- •History of congenital or acquired bleeding disorders, coagulation factor deficiency diseases, thrombocytopenic diseases, etc;
- •Anticipated difficulty in completing endovascular treatment due to vascular tortuosity;
- •Known severe allergy (more severe than skin rash) to contrast agents uncontrolled by medications;
- •Pregnancy, breastfeeding;
- •An episode or exacerbation of congestive heart failure from any cause in the past 6 months;
- •History of heart valve disease complicated by congestive heart failure within the past 6 months;
- •Cardiac surgery with thoracotomy (eg. coronary artery bypass grafting or valve replacement surgery) within the past 6 months;
- •Acute myocardial infarction in the past 6 months;
- •Signs or symptoms of acute myocardial infarction upon admission, including electrocardiographic findings;
- •Elevated serum troponin concentration upon admission (>0.1 μg/L) ;
- •Acute arrhythmia (including any tachycardia or bradycardia) with hemodynamic instability (systolic blood pressure <100 mm Hg) upon admission;
- •Acute or chronic lung diseases requiring long-term or intermittent oxygen therapy;
- •Findings on physical examination of any of the following abnormalities: (1) Jugular venous distension (jugular venous pulsation >4 cm above the sternal angle); (2) Resting tachycardia due to congestive heart failure (heart rate > 100 per/min); (3) Third heart sound; (4) Abnormal hepatic jugular venous reflux; (5) Pitting edema of the lower extremities attributable to congestive heart failure or without apparent cause; (6) Rales in both lungs; (7) Or evidence of pulmonary edema, pleural effusion, or pulmonary vascular redistribution on chest X-ray;
- •Severe chronic anemia (hemoglobin < 75 g/L);
- •Known recent or current serum creatinine exceeding 1.5 times the upper limit of normal, or estimated glomerular filtration rate (eGFR) < 60 mL/min;
- •Refractory hypertension that is difficult to control by medication (defined as systolic blood pressure > 220 mmHg, or diastolic blood pressure > 110 mmHg);
- •Serum alanine aminotransferase (ALT) or aspartate aminotransferase (AST) is greater than 1.5 times the upper limit of the normal value.
- •History of albumin allergy or known allergy to albumin;
- •Patients with severe mental disorders or dementia who are unable to cooperate in completing informed consent and follow-up content;
- •The expected survival time is less than 90 days (such as comorbidity with malignant tumor or severe systemic diseases etc.);
- •Patients who have participated in other interventional clinical studies within 30 days before randomization or are currently participating in other interventional clinical studies.
- •The investigator believes that the subject has other conditions making it unsuitable for participating in this study.
研究组 & 干预措施
Albumin combined with endovascular treatment group
Albumin combined with recommended endovascular treatment will be applied.
干预措施: Albumin (Drug)
Endovascular treatment group
Recommended endovascular treatment will be applied.
干预措施: Endovascular treatment (Procedure)
Albumin combined with endovascular treatment group
Albumin combined with recommended endovascular treatment will be applied.
干预措施: Endovascular treatment (Procedure)
结局指标
主要结局
Proportion of patients with mRS 0-2 or return to baseline mRS (if the baseline premorbid mRS =3-4) at 90 days.
时间窗: 90 days
Scores on the modified Rankin scale range from 0 (no neurologic deficit) to 6 (death)
Proportion of patients with functional independence at 90 days (mRS 0-2)
时间窗: 90 days
次要结局
- Distribution of mRS scores(90 days and 1 year)
- Proportion of patients with mRS score 0-1(90 days and 1 year)
- EuroQol Five-Dimension Five-Level Questionnaire (EQ-5D-5L)(90 days and 1 year)
- Proportion of Barthel Index (BI) ≥95(90 days and 1 year)
- Distribution of mRS scores at 90 days(90 days)
- Proportion of patients with mRS score 0-1 at 90 days(90 days)
- 24h National Institutes of Health Stroke Scale (NIHSS)(24 hours)
- National Institutes of Health Stroke Scale (NIHSS) at 7 days(7 days)
- EuroQol Five-Dimension Five-Level Questionnaire (EQ-5D-5L) at 90 days(90 days)
- Proportion of Barthel Index (BI) ≥95 at 90 days(90 days)
研究者
Ji Xunming,MD,PhD
Professor of Neurology, Xuanwu Hospital, Capital Medical University
Capital Medical University