Assess the Safety and Efficacy of a Seizure Medication,Levetiracetam(LEV;Keppra),in Neuroscience Intensive Care Unit Patients
| Status: | Completed |
|---|---|
| Conditions: | Hospital, Neurology |
| Therapuetic Areas: | Neurology, Other |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 5/3/2014 |
| Start Date: | August 2007 |
| End Date: | March 2010 |
| Contact: | Lori Shutter, MD |
| Email: | shuttel@healthall.com |
| Phone: | 1-513-584-8072 |
Assessment of Seizure Prophylaxis Protocols Using Intravenous Levetiracetam in a Neuroscience Intensive Care Unit
To show that the use of intravenous levitiracetam(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.
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.
To show that the use of intravenous levitiracetam(LEV;Keppra)for seizure prophylaxis in the
Neuroscience Intensive Care Unit will result in fewer adverse effects compared to the
current standard of care anticonvulsant(phenytoin) and will be at least as effective as
phenytoin in preventing clinical and sub-clinical seizure activity.
Neuroscience Intensive Care Unit will result in fewer adverse effects compared to the
current standard of care anticonvulsant(phenytoin) and will be at least as effective as
phenytoin in preventing clinical and sub-clinical seizure activity.
Inclusion Criteria:
Subjects with traumatic brain injury:
- 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 >90mmHg
- At least one reactive pupil
- A negative pregnancy test in females
- Age at least 18 years
- Signed informed consent and HIPAA authorization for research form OR Subjects with
subarachnoid hemorrhage
- SAH documented by CT scan
- Hunt-Hess grade 3-5, inclusive
- Hemodynamically stable with a systolic BP> 90mmHg
- At least one reactive pupil
- A negative pregnany test in females
- Age of at least 18 years
- Signed informed consent and HIPAA authorization for research form
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