Assess Safety and Efficacy of Levetiracetam(LEV;Keppra)for Seizure Prevention
Completed · Phase 4
Conditions studied: Traumatic Brain Injury, Subarachnoid Hemorrhage
In brief
To show that the use of intravenous levetiracetam(LEV;Keppra)for seizure prevention in patients in the Neuroscience Intensive Care Unit will result in fewer side effects compared to the current standard of care anticonvulsant and will be at least as effective as the current standard of care in preventing clinical and sub-clinical seizure activity.
Key facts
- Study ID
- NCT00618436
- Run by
- University of Cincinnati
- People needed
- 52
- Starts
- 2007-08-01
- Expected to finish
- 2009-09-01
- Last updated by the study team
- 2014-04-07
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Subjects with traumatic brain injury
- Glasgow Coma Score (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 mm Hg
- At least one reactive pupil
- A negative pregnancy test in females
- Age at least 18 years
- Signed informed consent and Health Insurance Portability and Accountability Act (HIPAA) authorization for research form OR
- Subjects with subarachnoid hemorrhage (SAH)
- SAH documented by CT scan
- Hunt-Hess grade 3-5, inclusive
- Hemodynamically stable with a systolic BP> 90 mm Hg
- At least one reactive pupil
- A negative pregnancy test in females
- Age of at least 18 years
- Signed informed consent and HIPAA authorization for research form
- Exclusion Criteria for enrollment
- 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
- Positive pregnancy test in females
- Age less than 18 years of age
- Known hypersensitivity to any anticonvulsant
Where it is running
- University of Cincinnati Hospital — Cincinnati, Ohio, United States
Full record on ClinicalTrials.gov
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