Assess Safety and Efficacy of Levetiracetam(LEV;Keppra)for Seizure Prevention (Keppra)
Traumatic Brain Injury, Subarachnoid Hemorrhage
About this trial
This is an interventional treatment trial for Traumatic Brain Injury focused on measuring Seizures, Traumatic Brain Injury, Subarachnoid Hemorrhage
Eligibility Criteria
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.
Sites / Locations
- University of Cincinnati Hospital
Arms of the Study
Arm 1
Arm 2
Active Comparator
Active Comparator
Levetiracetam
Phenytoin
Group 1 - The levetiracetam (Keppra®) group will receive a loading dose of 20 mg/kg IV over 15 minutes (rounded to the nearest 250mg) up to a maximum of 2000 mg, then started on maintenance dose (1000 mg, IV BID)as prophylaxis for 7 days.
Group 2-The phenytoin group will receive a loading dose of 20 mg/kg IV to a maximum of 2000mg, then started on maintenance dose at 5 mg/kg/day (rounded to nearest 100mg dose, IV, divided into three doses a day) as prophylaxis for 7 days. Phenytoin levels are to be checked daily and dose adjusted as needed to maintain therapeutic levels of 10-20 µg/dL.