Pilot Study of Seizure Prophylaxis With Levetiracetam in Aneurysmal Subarachnoid Hemorrhage
试验速览
- 阶段
- 4 期
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Randomization Yield
研究概览
简要总结
The purpose of this study is to determine the feasibility of prospectively enrolling and randomizing patients with aneurysmal subarachnoid hemorrhage (aSAH) to receive levetiracetam or not to receive levetiracetam, and documenting in-hospital and follow-up clinical variables.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •≥ 18 years of age
- •≤ 75 years of age
- •Newly diagnosed aneurysmal subarachnoid hemorrhage
排除标准
- •One or more antiepileptic medication is taken as a pre-admission medication
- •Seizure occurrence in the field or in the emergency department, or anytime before consent could be obtained
- •Inability to obtain informed consent from the patient, or from the patient's appropriate surrogate
研究组 & 干预措施
Treatment Group
levetiracetam 500mg in adults, twice daily, administered by mouth, per tube, or IV. The route of administration will be dependent upon the patient's clinical status and ability to tolerate each form. In descending order of preference, route of administration will be: oral, per tube, IV.
干预措施: levetiracetam (Drug)
结局指标
主要结局
Randomization Yield
时间窗: 6 months
The primary outcome will be the number of patients randomized to either levetiracetam administration or no administration of levetiracetam divided by the total number of aneurysmal subarachnoid hemorrhage patients who present to the Vanderbilt University Emergency Department or are directly admitted to the Neuro Intensive Care Unit. (Unit of Measure: numeric fraction)
次要结局
- Protocol Adherence Yield(9 months)