Expired Study
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Cincinnati, Ohio 45220


Purpose:

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.


Study summary:

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.


Criteria:

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


NCT ID:

NCT00618436


Primary Contact:

Principal Investigator
Lori Shutter, MD
Mayfield Clinic Inc

Lori Shutter, MD
Phone: 1-513-584-8072
Email: shuttel@healthall.com


Backup Contact:

Email: raj.narayan@uc.edu
Raj Narayan, MD
Phone: 1-513-475-7446


Location Contact:

Cincinnati, Ohio 45220
United States

Suzanne Kempisty, RN
Phone: 513-558-3590
Email: kempiss@ucmail.uc.edu

Site Status: Recruiting


Data Source: ClinicalTrials.gov

Date Processed: June 25, 2018

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