NCT03904017终止不适用
The Role of Hyperoxia in the Emergency Department Treatment of Acute Ischemic Stroke
适应症
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 13
- 试验地点
- 4
- 主要终点
- Mean Time to Randomization and Initiation of Intervention
研究概览
简要总结
This study is being conducted to evaluate the potential therapeutic role of hyperoxia when applied in the immediate ischemic period following a stroke in the controlled Emergency Department setting. The study will evaluate the effects of hyperoxia in stroke patients on the production of markers of free radical damage and inflammatory markers associated with hyperoxic lung injury.
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
- Double (Participant, Outcomes Assessor)
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
- •Provision of signed and dated informed consent form from patient or legal authorized representative (LAR)
- •Subject or LAR stated willingness to comply with all study procedures and availability for the duration of the study
- •Males and females (of unlikely childbearing capacity) aged over 18 years.
- •Exhibiting signs and physical examination findings suggestive of an acute ischemic infarction (either a or b)
- •A target mismatch profile of CT-perfusion or MRI determined by RAPID automated software to have a ratio of PWITmax>6 lesion volume/DWI lesion volume >1.2 and an NIHSS >/=1
- •A RAPID automated software calculated non-contrast CT-head ASPECT score of 10 and LKW ≤12 hours (in patients with symptoms discovered upon waking, the LKW is defined at the midpoint between going to sleep and awakening based on previous studies that suggest most strokes during sleep occur close to awakening)
- •Normoxic; a pulse oximetry of 94% or greater at time of screening without the use of supplemental oxygen
排除标准
- •Current use of supplemental oxygen
- •Documented blood glucose <70mg/dL
- •Concurrent treatment with another investigational drug or other intervention
- •Documented history of any of the following chronic respiratory illness that require pulmonary vasodilators or supplemental oxygen at baseline: Chronic Obstructive Pulmonary Disorder (COPD), Emphysema, Interstitial Lung Disease, Restrictive Lung Disease, Pulmonary Hypertension
- •Documented history of any of the following autoimmune diseases: systemic lupus erythematosus, rheumatoid arthritis, scleroderma, primary biliary cholangitis, multiple sclerosis, inflammatory bowel disease
- •Currently being treated for an acute myocardial infarction and/or decompensated heart failure at the onset of initial ED presentation as reported by the ED provider
- •Plans for treatment with either IV tPA (alteplase) or endovascular therapy
结局指标
主要结局
Mean Time to Randomization and Initiation of Intervention
时间窗: baseline
Patient arrival to the emergency department will be documented and recorded. They will be screened for participation by study personnel. Once consented and randomized, the time of initiation of intervention will be recorded. The mean time from emergency department presentation to initiation of therapy will be determined.
次要结局
- Mean Ratio of the Volume of Initial Hypoperfused Tissue to Final Infarct Volume(one week)
- Change in Mean NIHSS(baseline to 24-hours)
研究者
研究点 (4)
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