Seizure Prophylaxis in Aneurysm Repair
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 82
- 试验地点
- 1
- 主要终点
- Incidence of Seizure
研究概览
简要总结
After a thorough review of the existing literature as well as a review of our own practice, the investigators have concluded that the decision to treat patients undergoing aneurysm repair with levetiracetam has reached true clinical equipoise. In other words, the investigators cannot favor a decision to either administer or not administer this drug in these patients based on the existing information. The utility of anti-epileptic prophlaxis in the perioperative period for patients undergoing intracranial aneurysm repair remains a common practice that is not supported by the current literature that includes retrospective analyses as well as prospective trials for similar but not identical types of patients. The investigators propose to settle this dilemma by performing a prospective randomized trial in patients undergoing aneurysm repair in order to definitively determine if the common practice of perioperative antiepileptic drug administration has any utility. The study will be extended to June 2024 to allow for a 5 year follow up of the last enrolled patient in June, 2019.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult (≥18 years)
- •Presence of intracranial aneurysm (with or without rupture)
- •Treating surgeon has recommended surgical repair of the aneurysm
排除标准
- •History of seizures within last 10 years
- •History of epilepsy
- •History of prior stroke
- •Currently prescribed medication with anti-epileptic activity (keppra, dilantin, tegretol, lamictal, topamax, etc.)
- •Brain tumor
- •Pregnant or nursing woman
- •Known levetiracetam allergy
研究组 & 干预措施
Levetiracetam
500 mg intravenous dose during the operative case then 500 mg orally twice a day for a total of seven days.
干预措施: Levetiracetam (Drug)
结局指标
主要结局
Incidence of Seizure
时间窗: 5 years from procedure
Incidence of seizure reported as number of participants who had at least one seizure within the relevant date range. Data collected at hospital discharge, 1-2 months, 4-6 months, 6-12 months, and 5 years. Data is not cumulative. Counts reflect the number of participants who experienced a seizure since their previous check-in.
次要结局
- Duration of Seizure(To compare duration of seizure in each randomization group)
研究者
Aditya S. Pandey, MD
Professor of Neurosurgery, Chair, Department of Neurosurgery, Professor of Radiology
University of Michigan