Early Identification of Malignant Brain Edema in laRge Artery oCclusive Stroke After Endovascular Therapy (EMBRACE Study)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 1,950
- 试验地点
- 1
- 主要终点
- The occurrence of MBE
研究概览
简要总结
To design and validate a predictive model for malignant brain edema after endovascular thrombectomy.
详细描述
Stroke is a significant global cause of death and disability. Endovascular thrombectomy (EVT) is currently the best treatment for acute large vessel occlusion stroke (ALVOS), as it can greatly reduce mortality and improve patient outcomes. However, only half of patients who undergo EVT achieve functional independence, and malignant brain edema (MBE), a severe complication, can occur after the procedure, leading to a poor prognosis. Previous studies have confirmed the effectiveness of early decompressive hemicraniectomy in reducing morbidity and mortality in patients with malignant brain edema. Therefore, identifying high-risk patients for MBE can help clinicians make appropriate triage and early intervention decisions, potentially saving patients' lives.
Predictive factors for post-ischemic stroke brain edema have been widely discussed, and reliable early predictive indicators have been identified, such as age, early consciousness disorders, baseline National Institutes of Health Stroke Scale (NIHSS), atrial fibrillation, hypertension, baseline blood glucose, and the level of reperfusion after EVT. Radiological factors, such as the Alberta Stroke Program Early CT Score (ASPECTS), collateral circulation rating of arteries, venous outflow status, CT perfusion core infarct volume, perfusion-based collateral status, and clot burden, are closely associated with the occurrence of MBE post-EVT. However, due to individual differences and multiple factors affecting MBE, a single factor cannot effectively predict MBE. Establishing a clinical risk prediction model can effectively identify high-risk populations for MBE at an early stage.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
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
- •(1)Age > 18 years old; (2)Onset of stroke to hospital admission < 24 hours; (3)Admission with a head CT scan ruling out hemorrhage; (4)Patients undergoing CT perfusion scan before treatment; (5)Confirmation of internal carotid artery (ICA) or middle cerebral artery (MCA) occlusion or tandem occlusion by Digital Subtraction Angiography (DSA) and subsequent EVT; (6)complete 3-months follow-up.
排除标准
- •(1)Poor quality of preoperative CT perfusion imaging; (2)Posterior circulation occlusion or isolated anterior cerebral artery occlusion; (3)Presence of other severe diseases such as malignant tumors, severe organ failure, or other life-threatening conditions with an expected survival period of less than 90 days; (4)Incomplete imaging and clinical data.
结局指标
主要结局
The occurrence of MBE
时间窗: 3 days post-EVT
Patients developed MBE within 3 days post-EVT
次要结局
- 90 days mRS score(90 days after EVT)
- PH(3-5 days after EVT)
