Field Administration of Stroke Therapy-Magnesium Trial: A Randomized, Double-Blind, Placebo Controlled Trial of Neuroprotective Magnesium Sulfate Therapy for Acute Stroke Initiated Within 2 Hours of Onset by Paramedics in the Field
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 1,700
- 试验地点
- 1
- 主要终点
- Modified Rankin Scale
研究概览
简要总结
The goal of this study is to evaluate the effectiveness and safety of field-initiated magnesium sulfate in improving the long-term functional outcome of patients with acute stroke.
详细描述
Stroke is the third leading cause of death and the leading cause of adult disability in the United States. Each year, more than 750,000 Americans suffer a symptomatic stroke.
Currently, tissue plasminogen activator (rt-PA) is the only approved treatment for acute ischemic stroke; however, its usefulness is limited because most patients cannot reach medical attention within the necessary 3-hour time window. In addition, rt-PA cannot be given in the field because it is contraindicated for treatment of patients with brain hemorrhage.
The purpose of this multi-center, randomized, double-blind trial is to demonstrate that paramedic initiation of the neuroprotective agent magnesium sulfate in the field is an effective and safe treatment for acute stroke. This study will analyze magnesium sulfate, an experimental therapy for stroke, versus placebo among ambulance-transported patients with acute stroke. This trial will also demonstrate that paramedics can safely, effectively, and rapidly start neuroprotective therapies for stroke.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 40 Years 至 95 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Suspected stroke identified by the Los Angeles Prehospital Stroke Screen
- •Age 40-95, inclusive
- •Last known well time within 2 hours of treatment initiation
- •Deficit present for >/= 15 minutes
排除标准
- •Rapidly improving neurologic deficit
- •Pre-existing neurologic, psychiatric, or advanced systemic disease that would confound the neurological or functional outcome evaluations
- •Systolic Blood Pressure (SBP) < 90 or > 220
- •Known severe renal dysfunction (on dialysis or known chronic creatinine > 3.0)
- •Severe respiratory distress (O2 sat < 90% or respiratory rate < 12 or >/= 24)
- •Known second or third degree heart block with no pacemaker in place
- •Major head trauma in the last 24 hours
- •Recent stroke within prior 30 days
- •Patient unable to give informed consent and no available on scene consent or assent provider
研究组 & 干预措施
Magnesium Sulfate
Magnesium sulfate (Mg) was administered intravenously with a 15 minute bolus load followed by a 24 hour infusion. The bolus-loading dose consisted of 4 grams Mg in 54 ml normal saline. The maintenance infusion contained 16 grams Mg diluted in 240 ml 0.9% normal saline, infused at 10 ml/hr for 24 hours. Paramedics in the field initiated the bolus-loading dose, administered at 216 ml/hr over 15 minutes through a rate controlled IV infusion set. The maintenance infusion was initiated in hospital immediately upon completion of the loading dose.
干预措施: Magnesium Sulfate (Drug)
Normal saline
Normal saline was administered intravenously with a 15 minute bolus load followed by a 24 hour infusion. Paramedics in the field initiated the bolus-loading dose of 54 ml normal saline, administered at 216 ml/hr over 15 minutes through a rate controlled IV infusion set. The maintenance infusion was initiated in hospital immediately upon completion of the loading dose at 10 ml/hr for 24 hours.
干预措施: Normal Saline (Drug)
结局指标
主要结局
Modified Rankin Scale
时间窗: 3 months after stroke onset
Modified Rankin Scales (mRS) is a measure of global disability. Total Scale range is 0-6, with lower values indicating better outcomes. 0 No symptoms at all 1. No significant disability despite symptoms; able to carry out all usual duties and activities 2. Slight disability; unable to carry out all previous activities, but able to look after own affairs without assistance 3. Moderate disability; requiring some help, but able to walk without assistance 4. Moderately severe disability; unable to walk without assistance and unable to attend to own bodily needs without assistance 5. Severe disability; bedridden, incontinent and requiring constant nursing care and attention 6. Dead
次要结局
- Modified Rankin Score of 0 or 1(3 months)
- Modified Rankin Score ≤2(3 months)
- NIH Stroke Scale(3 months)
- Barthel Index(3 months)
- Stroke Impact Scale(3 months)
- Serious Adverse Events(3 months)
- Symptomatic Intracranial Hemorrhage(3 month)
- Mortality(3 months)
研究者
Jeffrey L. Saver
Professor of Neurology
University of California, Los Angeles