Clinical trial NCT00618436: Assess Safety and Efficacy of Levetiracetam(LEV;Keppra)for Seizure Prevention
Official title: Assessment of Seizure Prophylaxis Protocols Using Intravenous Levetiracetam in a Neuroscience Intensive Care Unit
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Traumatic Brain Injury
Subarachnoid Hemorrhage
Keywords: Seizures
Traumatic Brain Injury
Subarachnoid Hemorrhage
Lead sponsor: University of Cincinnati
Sponsor class: OTHER
Collaborators: name: Mayfield Clinic & Spine Institute
First posted: 2008-02-20
Enrollment: 52
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

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.

Primary outcomes:
measure: Seizure Incidence
timeFrame: Duration of study, up to 6 months after the injury
Secondary outcomes:
measure: Extended Glasgow Outcome Score
timeFrame: at discharge; 3 and 6 months following injury
measure: Disability Rating Scale (DRS)
timeFrame: Discharge; 3 and 6 months following injury
measure: Incidence of Adverse Events
timeFrame: discharge; 3 and 6 months following injury
Other outcomes:
Locations:
city: Cincinnati
country: United States
facility: University of Cincinnati Hospital
state: Ohio
Study officials:
affiliation: University of Pittsburgh
name: Lori Shutter, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Steinbaugh LA, Lindsell CJ, Shutter LA, Szaflarski JP. Initial EEG predicts outcomes in a trial of levetiracetam vs. fosphenytoin for seizure prevention. Epilepsy Behav. 2012 Mar;23(3):280-4. doi: 10.1016/j.yebeh.2011.12.005. Epub 2012 Feb 16.