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Completed

NCT Number: NCT00618436

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

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Levetiracetam

Drug

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.

Other names: Keppra

Phenytoin

Drug

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.

Other names: Dilantin

Primary outcomes

  1. Seizure Incidence

    Time frame: Duration of study, up to 6 months after the injury

    This was the number of patients in each group who demonstrated seizure activity during the course of the study

Secondary outcomes

  1. Extended Glasgow Outcome Score

    Time frame: at discharge; 3 and 6 months following injury

    This is an 8 point validated scale that measures disability after brain injury. It is assessed through an in person exam or by phone interview at hospital discharge, 3 months and 6 months after injury. The categories are: 1 = dead; 2 = vegetative state; 3 = severe disability, low level; 4 = severe disability, high level; 5 = moderate disability, low level; 6 = moderate disability, high level; 7 = good recovery - low level; 8 = good recovery - high level. Specific questions and activities are assessed to determine into which category the patient falls.

  2. Disability Rating Scale (DRS)

    Time frame: Discharge; 3 and 6 months following injury

    The Disability rating scale (DRS) is frequently used in the rehabilitation literature as a measure of disability. It is a reliable, easily performed test that assesses 8 items (eye opening, verbalization, motor response, feeding, toileting, grooming, level of functioning, employability), and assigns each a numerical score ranging from 0 - 5 based on the category. The domains these 8 items are felt to assess include: alertness, cognition for self-care, dependence, and psychosocial adaptability. The scoring range is from 0-30, with increasing disability levels assigned to higher numerical values. The total DRS is then dichotomized into favorable (disability = none, mild, partial or moderate disability) and unfavorable (disability = moderately severe, severe, extremely severe, vegetative state, extreme vegetative state, death) outcomes. A DRS score of 0-6 was favorable, with any score greater than 6 categorized as unfavorable.

  3. Incidence of Adverse Events

    Time frame: discharge; 3 and 6 months following injury

Sponsors and collaborators

Lead sponsor

University of Cincinnati

Other

Collaborators

  • Mayfield Clinic & Spine Institute

Registry information

Official study title

Assessment of Seizure Prophylaxis Protocols Using Intravenous Levetiracetam in a Neuroscience Intensive Care Unit

Acronym: Keppra

Important dates

Study start
2007
Primary completion
2009
Study completion
2009
First posted
Feb 20, 2008
Registry last updated
Apr 7, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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