Does Short-Term Anti-Seizure Prophylaxis After Traumatic Brain Injury Decrease Seizure Rates?
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 2,300
- 试验地点
- 1
- 主要终点
- Seizures (count of seizures)
研究概览
简要总结
The primary objective of this study is to prospectively assess in randomized fashion whether short term anti-seizure prophylaxis in traumatic brain injured patients decreases the incidence of seizures in the early post-injury period. A secondary objective is to evaluate whether there are differences in mortality, hospital length of stay, functional outcome at hospital discharge, hospital cost, discharge status (home, rehabilitation facility, etc.) for patients who receive and do not receive anti-seizure prophylaxis.
详细描述
The efficacy of anti-seizure prophylaxis in head injury patients remains controversial. Current recommendations for the use of anti-seizure prophylaxis are based upon a single institution study that has not been reproduced with other studies contradicting their conclusions. The proposed study will be a randomized prospective study at Loyola University Medical Center to assess the efficacy of anti-seizure prophylaxis in patients who have suffered traumatic brain injury (TBI). Patients with suspected TBI will undergo computed tomographic (CT) scan of the head. Following identification of TBI on CT scan, patients will be randomized to one of two study groups. Patients will be randomized to receive a seven-day course of anti-seizure prophylaxis with levetiracetam (UCB Pharma Inc.; Keppra) or randomized to a study group that will not receive anti-seizure prophylaxis. Patients will be consented prior to entry in the study. Patients will be followed for a total of seven days post injury for clinical signs of seizure activity. Additionally, patients will be assessed at one month post injury for clinical signs of seizure activity.
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
- •Patients who have suffered intracranial injury identified by CT Scan
排除标准
- •Age less than 18
- •Pregnant patients
- •Death in ED
- •Seizure history or use of antiepileptic medication prior to admission
- •Contraindication to study drug
- •Any post-injury seizures prior to randomization
研究组 & 干预措施
Seizure Prophylaxis
Participants randomized to this arm will receive the anti-seizure prophylaxis drug Levetiracetam for seven days post traumatic brain injury.
干预措施: Levetiracetam (Drug)
结局指标
主要结局
Seizures (count of seizures)
时间窗: 30 days
For all patients, the count of seizures will be recorded and compared between the two arms
次要结局
- Mortality(30 days)
研究者
Richard Gonzalez
Professor
Loyola University