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Sponsored by: |
Mayfield Clinic & Spine Institute |
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Information provided by: | Mayfield Clinic & Spine Institute |
ClinicalTrials.gov Identifier: | NCT00618436 |
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.
Condition | Intervention |
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Traumatic Brain Injury Subarachnoid Hemorrhage |
Drug: Levetiracetam Drug: Phenytoin |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Single Blind (Outcomes Assessor), Active Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Assessment of Seizure Prophylaxis Protocols Using Intravenous Levetiracetam in a Neuroscience Intensive Care Unit |
Estimated Enrollment: | 104 |
Study Start Date: | August 2007 |
Estimated Study Completion Date: | March 2010 |
Estimated Primary Completion Date: | August 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Active Comparator
Group 1-treatment with Levetiracetam
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Drug: Levetiracetam
Levetiracetam group will receive a loading dose of 20 mg/kg IV(rounded to nearest 250mg) to a maximum of 2000mg, then started on maintenance dose (1000 mg,IV q 12h) as prophylaxis for seven days.
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2: Active Comparator
Group 2-treatment with Phenytoin
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Drug: Phenytoin
The group will receive a loading dose of fosphenytoin 20 mg/kg IV to a maximum of 2000 mg, then started on maintenance dose of 5mg/kg/day, rounded to nearest 100mg dose, IV, q 12h for seven days.
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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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Subjects with traumatic brain injury:
Contact: Lori Shutter, MD | 1-513-584-8072 | shuttel@healthall.com |
Contact: Raj Narayan, MD | 1-513-475-7446 | raj.narayan@uc.edu |
United States, Ohio | |
University of Cincinnati Hospital | Recruiting |
Cincinnati, Ohio, United States, 45220 | |
Contact: Suzanne Kempisty, RN 513-558-3590 kempiss@ucmail.uc.edu |
Principal Investigator: | Lori Shutter, MD | Mayfield Clinic Inc |
Responsible Party: | Mayfield Clinic Inc ( Lori Shutter, MD ) |
Study ID Numbers: | 06-4-6-7 |
Study First Received: | February 8, 2008 |
Last Updated: | February 19, 2008 |
ClinicalTrials.gov Identifier: | NCT00618436 History of Changes |
Health Authority: | United States: Institutional Review Board |
Seizures Traumatic Brain Injury Subarachnoid Hemorrhage |
Craniocerebral Trauma Nootropic Agents Seizures Vascular Diseases Wounds and Injuries Central Nervous System Diseases Disorders of Environmental Origin Intracranial Hemorrhages Trauma, Nervous System |
Hemorrhage Brain Diseases Cerebrovascular Disorders Fosphenytoin Phenytoin Subarachnoid Hemorrhage Etiracetam Brain Injuries Anticonvulsants |
Craniocerebral Trauma Nootropic Agents Nervous System Diseases Wounds and Injuries Vascular Diseases Disorders of Environmental Origin Central Nervous System Diseases Intracranial Hemorrhages Trauma, Nervous System Hemorrhage Brain Diseases |
Cerebrovascular Disorders Pharmacologic Actions Pathologic Processes Therapeutic Uses Subarachnoid Hemorrhage Etiracetam Cardiovascular Diseases Brain Injuries Central Nervous System Agents Anticonvulsants |