Status:
COMPLETED
Assess Safety and Efficacy of Levetiracetam(LEV;Keppra)for Seizure Prevention
Lead Sponsor:
University of Cincinnati
Collaborating Sponsors:
Mayfield Clinic & Spine Institute
Conditions:
Traumatic Brain Injury
Subarachnoid Hemorrhage
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
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 standa...
Detailed Description
To show that the use of intravenous levetiracetam(LEV;Keppra)for seizure prophylaxis in the Neuroscience Intensive Care Unit will result in fewer adverse effects compared to the current standard of ca...
Eligibility Criteria
Inclusion
- Inclusion Criteria:
- 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
- An injury that, in the opinion of the principal investigator, has a high likelihood of death within the first 72 hours.
- Any treatment, condition, or injury that contraindicates treatment with LEV (levetiracetam) or phenytoin (PHT).
- Inability to obtain signed informed consent or HIPAA authorization for research.
Exclusion
Key Trial Info
Start Date :
August 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2009
Estimated Enrollment :
52 Patients enrolled
Trial Details
Trial ID
NCT00618436
Start Date
August 1 2007
End Date
September 1 2009
Last Update
April 7 2014
Active Locations (1)
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1
University of Cincinnati Hospital
Cincinnati, Ohio, United States, 45220