NCT01974700终止4 期
Seizure Prophylaxis in Aneurysm Repair
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 入组人数
- 17
- 试验地点
- 1
- 主要终点
- Incidence of Seizure
研究概览
简要总结
Seizures are a potential complication of surgical repair of intracranial aneurysms. In order to prevent seizures, many surgeons administer prophylactic anti-epileptic medication during the intra-operative and post-operative period, however, such practice is not supported by clinical data. Retrospective review found the incidence of postoperative seizures was higher in those who received anti-epileptics versus those who did not. The goal is to examine the utility of levetiracetam (Keppra) for seizure prophylaxis in patients undergoing surgical repair of unruptured intracranial aneurysms.
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
- 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 (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
Active Comparator
干预措施: Levetiracetam (Drug)
结局指标
主要结局
Incidence of Seizure
时间窗: 6 mo - 1 Year from Operative Procedure
Reported via patient in follow-up phone call.
次要结局
- Number of Participants Who Returned to Daily Activities.(6 months - 12 months)
- Number of Participants Who Returned to Work(6 months - 12 months)
研究者
研究点 (1)
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