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

University of Cincinnati

Status and phase: Completed; Phase 4

Conditions: Subarachnoid Hemorrhage; Traumatic Brain Injury

Treatments: Drug: Levetiracetam; Drug: Phenytoin

Study type: Interventional

Funder types: Other

Identifiers

NCT00618436

06-4-6-7

Details and patient eligibility

About

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.

Full 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 care anticonvulsant(phenytoin) and will be at least as effective as phenytoin in preventing clinical and sub-clinical seizure activity.

Enrollment: 52 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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52 participants in 2 patient groups

Levetiracetam

Active Comparator group

Description:

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.

Treatment:

Drug: Levetiracetam

Phenytoin

Active Comparator group

Description:

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.

Treatment:

Drug: Phenytoin