Assess the Safety and Efficacy of a Seizure Medication,Levetiracetam(LEV;Keppra),in Neuroscience Intensive Care Unit Patients
Information source: Mayfield Clinic & Spine Institute
Information obtained from ClinicalTrials.gov on November 03, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Traumatic Brain Injury; Subarachnoid Hemorrhage
Intervention: Levetiracetam (Drug); Phenytoin (Drug)
Phase: N/A
Status: Recruiting
Sponsored by: Mayfield Clinic & Spine Institute Official(s) and/or principal investigator(s):
Lori Shutter, MD, Principal Investigator, Affiliation: Mayfield Clinic Inc
Overall contact:
Lori Shutter, MD, Phone: 1-513-584-8072, Email: shuttel@healthall.com
Summary
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.
Clinical Details
Official title: Assessment of Seizure Prophylaxis Protocols Using Intravenous Levetiracetam in a Neuroscience Intensive Care Unit
Study design: Treatment, Randomized, Single Blind (Outcomes Assessor), Active Control, Parallel Assignment, Safety/Efficacy Study
Primary outcome: Seizure frequency
Secondary outcome: Extended GOSEDisability Rating Scale Incidence of adverse events
Detailed description:
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.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
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
Locations and Contacts
Lori Shutter, MD, Phone: 1-513-584-8072, Email: shuttel@healthall.com
University of Cincinnati Hospital, Cincinnati, Ohio 45220, United States; Recruiting
Suzanne Kempisty, RN, Phone: 513-558-3590, Email: kempiss@ucmail.uc.edu
Additional Information
Starting date: August 2007
Ending date: March 2010
Last updated: February 19, 2008
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