A Pilot Study of NSICU Assessment of Seizure Prophylaxis With Lacosamide
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 11
- 试验地点
- 3
- 主要终点
- Number of Adverse Events
研究概览
简要总结
Trial to determine if seizure prophylaxis with IV LCM in NSICU patients experiencing mental status changes due to severe traumatic brain injury (sTBI) will result in improved short- and long-term outcomes and better immediate adverse effects when compared to the current standard of care anticonvulsant (IV fPHT) and will be at least as effective as IV fPHT in preventing clinical and sub-clinical seizure activity.
详细描述
The goals are to compare IV LCM and IV fPHT for seizure prophylaxis in the neuro-critical care setting in terms of the following outcome measures:
- The short- and long-term incidence of adverse events related to the anticonvulsant medication
- The frequency of clinically-evident and sub-clinical seizures, as demonstrated by continuous EEG monitoring for the first three days and by clinical assessment for up to 6 months after initial admission.
- Intermediate and long-term outcomes as measured by standard outcome measures including Extended Glasgow Outcome Scale, Disability Rating Scale, and Resource Utilization Questionnaire
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
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
- •Subject with traumatic brain injury admitted to the hospital less than 24 hours prior to randomization
- •GCS score 3-8 (inclusive) or GCS motor score of 5 or less and abnormal admission CT scan showing intracranial pathology
- •Hemodynamically stable with a systolic BP > 90 mmHg
- •At least one reactive pupil
- •Age at least 18 years
- •Signed informed consent and HIPAA authorization for research form
- •Patients will not be excluded because of race, gender, educational status or occupation
排除标准
- •No venous access
- •Spinal cord injury
- •History of or CT confirmation of previous brain injury such as brain tumor, cerebral infarct, or spontaneous intracerebral hemorrhage
- •Hemodynamically unstable
- •Suspected anoxic events
- •Other peripheral trauma likely to result in liver failure
- •Age less than 18 years of age
- •Known hypersensitivity to any anticonvulsant
- •Any treatment, condition, or injury that contraindicates treatment with Lacosamide (LCM) or fos-phenytoin (fPHT)
- •Inability to obtain signed informed consent or HIPAA authorization for research
研究组 & 干预措施
IV LCM (lacosamide)
Patients with severe traumatic brain injury (TBI) or subarachanoid hemorrhage (SAH) randomized to seizure prophylaxis with either lacosamide.
干预措施: lacosamide (Drug)
IV fPHT (fos-phenytoin)
Patients with TBI or SAH randomized to seizure prophylaxis with fos-phenytoin
干预措施: Fosphenytoin (Drug)
结局指标
主要结局
Number of Adverse Events
时间窗: baseline to 7 days
The primary outcome measure is the incidence of clinical adverse events. These will be followed by daily clinical observations during the hospital stay. Subjects will be evaluated for e.g., seizures, fever, neurological changes, cardiovascular, hematologic and dermatologic abnormalities, liver failure, renal failure, and death; EKGs will be requested as per ICU routines through day 7.
次要结局
- Number of Participants With Seizures(baseline to 72 hours)
研究者
Jerzy P Szaflarski
Professor
University of Alabama at Birmingham