Assess Safety and Efficacy of Levetiracetam(LEV;Keppra)for Seizure Prevention

• Status: Completed
• Trial end date: 2009-09-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Cincinnati
• Collaborator: Mayfield Clinic & Spine Institute
• Treatments: Etiracetam; Levetiracetam; Phenytoin; Piracetam

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.