The Level of Blood Brain Barrier Damage Biomarker Predicting Hemorrhagic Transformation Following Acute Ischemic Stroke
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 1,000
- 试验地点
- 1
- 主要终点
- The change of serum biomarkers within 72h in ischemic stroke patients
研究概览
简要总结
Hemorrhagic transformation is a common complication of acute ischemic stroke patients . BBB damage is regarded as a major pathophysiological mechanism of hemorrhagic transformation. So, the investigators hypothesis the level of BBB damage biomarker is predictor of intracranial hemorrhage following ischemic stroke.
详细描述
Hemorrhagic transformation is a common complication of acute ischemic stroke patients . BBB injury often occurs in the early stage of ischemic stroke, leading brain tissue edema or even hemorrhagic transformation with the development of ischemic injury. The biomarker of BBB damage, such as the level of serum occludin, can reflect the extent of BBB injury. So, the investigators hypothesis the level of BBB damage biomarker is predictor of intracranial hemorrhage following ischemic stroke.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 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
- •Enrolled patients aged 18-80years.
- •Acute ischemic stroke
- •Informed consent obtained.
排除标准
- •Tumor stroke or hemorrhagic stroke or hemorrhagic cerebral infarction on admission.
- •Stroke or serious head trauma within the previous 3 months
- •inflammatory or infectious diseases, cancer, coagulation disturbance disease and severe renal and liver failure
- •blood sample occurred hemolysis or cloudy.
- •Incomplete clinical data
- •Platelet count of less than 100,000 per cubic millimeter
- •Received oral anticoagulation therapy preceding the onset of stroke and INR greater than 1.7 or prothrombin times greater than 15 seconds
- •Pregnant or breast-feeding women
- •Patients being enrolled or having been enrolled in other clinical trial -
结局指标
主要结局
The change of serum biomarkers within 72h in ischemic stroke patients
时间窗: Day 0, Day 1, Day 2, Day 3.
The level of biomarkers are detected using Elisa(Enzyme Linked Immunosorbent Assay)，biomarkers including Occludin(ng/mL), Claudin-5(ng/mL), MMP-2/9(ng/mL)，c-Fn(ug/mL), ZO-1(pg/mL), vWF(ng/mL), IL-2RA(ng/mL), CCL16(ng/mL), CNTN(ng/mL), SELE(ng/mL) and PGLYRP1(ng/mL).
次要结局
未报告次要终点
研究者
Ji Xunming,MD,PhD
Professor of Neurosurgery, Vice-President of Xuan Wu Hospital
Capital Medical University