NCT02974283Unknown不适用
The Effect of Normobaric Hyperoxia on Blood Brain Barrier in AIS Patients Based on a Blood Marker for the Evaluation of Blood Brain Barrier Damage From Animal Experiments
Capital Medical University0 个研究点目标入组 40 人开始时间: 2016年12月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 40
- 主要终点
- Scores assessed by National Institutes of Health Stroke Scale(NIHSS)
研究概览
简要总结
The purpose of this study is to find out a serum marker for the evaluation of blood brain barrier damage based on animal experiments and investigate the effect of NBO（Normobaric hyperoxia）on blood brain barrier in the acute ischemic stroke patients who received r-tPA thrombolytic therapy.
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 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female with age from 18 to 85;
- •Acute ischemic stroke;
- •National Institutes of Health Stroke Scale (NIHSS) score of 4-25
- •mRS score less than 1 before onset of stroke symptom;
- •Onset of stroke symptoms within 4.5h before initiation of intravenous r-tPA thrombolytic therapy;
- •Informed consent obtained
排除标准
- •Stroke or serious head trauma within the previous 3 months
- •Major surgery or severe trauma with in the preceding 3 months
- •Intracranial hemorrhage
- •Systolic pressure greater than 185 mm Hg or diastolic pressure greater than 110 mm Hg, or aggressive treatment intravenous medication) necessary to reduce blood pressure to these limits
- •Symptoms rapidly improving
- •Symptoms suggestive of subarachnoid hemorrhage, even if CT scan was normal
- •Gastrointestinal hemorrhage or urinary tract hemorrhage within the previous 21 days
- •Arterial puncture at a noncompressible site within the previous 7 days
- •Seizure at the onset of stroke
- •Platelet count of less than 100,000 per cubic millimeter
- •Received heparin within the 48 hours preceding the onset of stroke and had an elevated partial-thromboplastin time
- •Received oral anticoagulation therapy preceding the onset of stroke and INR greater than 1.7 or prothrombin times greater than 15 seconds
- •CT showed a multiple infarction (low density area greater than 1/3 cerebral hemisphere)
- •severe hepatic or renal dysfunction
- •active and chronic obstructive pulmonary disease or acute respiratory distress syndrome;
- •>3 L/min oxygen required to maintain peripheral arterial oxygen saturation (SaO2)﹥95% as per current stroke management guidelines; 17 medically unstable;
- •inability to obtain informed consent.
- •Life expectancy<1 years
- •Pregnant or breast-feeding women
- •Unwilling to be followed up or poor compliance for treatment
- •Patients being enrolled or having been enrolled in other clinical trial within 3 months prior to this clinical trial
结局指标
主要结局
Scores assessed by National Institutes of Health Stroke Scale(NIHSS)
时间窗: 7days
levels of blood biomarkers
时间窗: 7days
a serum marker for the evaluation of blood brain barrier damage based on animal experiments
次要结局
- Number of participants with adverse events that are related to treatment(7days)
研究者
Ji Xunming
professor
Capital Medical University
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