Assess Safety and Efficacy of Levetiracetam(LEV;Keppra)for Seizure Prevention
Condition: Traumatic Brain Injury; Subarachnoid Hemorrhage
MeSH terms: Brain Injuries; Brain Injuries, Traumatic; Seizures; Subarachnoid Hemorrhage; Hemorrhage
Intervention: Levetiracetam; Phenytoin
Intervention description: 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.; 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.
Intervention MeSH terms: Phenytoin; Levetiracetam
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Enrollment: 52.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Seizures; Traumatic Brain Injury; Subarachnoid Hemorrhage

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 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.
    

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.