Safety of Intravenous Thrombolytics in Stroke on Awakening
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Number of Participants With Symptomatic Intracerebral Hemorrhage Within 36 Hours of Treatment
研究概览
简要总结
The primary objective of this study is to evaluate the safety of intravenous tissue plasminogen activator (IV tPA) in patients waking up with symptoms of acute stroke and presenting to the Emergency Department (ED) within 4.5 hours from awakening, and meeting standard criteria for treatment with IV tPA for acute stroke.
The hypothesis is that patients that wake up with stroke symptoms may have developed the stroke at the time of awakening, and may be within the 4.5 hour window if they arrive to the ED within that time, therefore IV tPA should be safe and effective in this population.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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 greater or equal to 18 years, and lower or equal to 80 years.
- •Signs and symptoms of acute ischemic stroke.
- •Symptoms present upon awakening.
- •Arriving to the Emergency Department within 4.5 hours of awakening. Treatment with IV tPA must be initiated prior to 4.5hours from waking up.
- •NIHSS >3
- •A non-contrast head CT without hemorrhage and without hypodensity more than 1/3 of the middle cerebral artery (MCA) territory; or MRI demonstrating no hemorrhage, and with a diffusion-weighted imaging (DWI) lesion no greater than 70 mL and FLAIR without a well defined hyperintense lesion that is more than 1/3 of the MCA territory.
- •Pre-morbid modified Rankin score of 0 or 1.
排除标准
- •Rapidly improving deficit to an NIHSS less than
- •Sustained systolic blood pressure greater than 185 mmHg or diastolic blood pressure greater than 110 mmHg despite treatment.
- •Glucose less than 50 mg/dL.
- •Stroke or head trauma within last 3 months.
- •History of intracranial hemorrhage. Symptoms of subarachnoid hemorrhage.
- •Major surgery within 14 days.
- •Gastrointestinal (GI)/Genito-urinary (GU) hemorrhage within 21 days.
- •International normalized ratio (INR) > 1.
- •Heparin within 48 hours with an elevated activated partial thromboplastin time (aPTT).
- •Platelet count less than 100,
- •Presumed septic embolus or suspicion of bacterial endocarditis.
- •Suspicion of aortic dissection.
- •Use of anticoagulants such as dabigatran, rivaroxaban, apixaban, enoxaparin.
- •Pregnant or lactating women.
- •Known allergy or sensitivity to tPA.
研究组 & 干预措施
IV tPA
Treatment will be initiated within 4.5 hours of awakening, for patients who meet inclusion criteria
干预措施: tPA (Drug)
结局指标
主要结局
Number of Participants With Symptomatic Intracerebral Hemorrhage Within 36 Hours of Treatment
时间窗: within 36 hours of treatment
Symptomatic intracerebral hemorrhage by using the European Cooperative Acute Stroke Study (ECASS) 3 criteria as well as the original National Institutes of Neurological Disorders and Stroke (NINDS) Intravenous tissue plasminogen activator (IV tPA) trial criteria for comparison. ECASS 3 criteria: hemorrhage in brain imaging, and an increase of 4 or more points on the National Institutes of Health Stroke Scale (NIHSS) from baseline. NINDS IV tPA trial criteria: a hemorrhage not seen in previous brain imaging, associated with a neurological decline attributable to the hemorrhage.
次要结局
- Functional Outcome by the Modified Rankin Scale at 90 Days(90 days)
研究者
Victor C Urrutia, MD
Associate Professor
Johns Hopkins University