Completed
KeppraAssessment of Seizure Prophylaxis Protocols Using Intravenous Levetiracetam in a Neuroscience Intensive Care Unit
What is being tested
Levetiracetam
+ Phenytoin
Drug
Who is being recruted
Brain Injuries, Traumatic+16
+ Brain Diseases
+ Brain Injuries
Over 18 Years
+27 Eligibility Criteria
How is the trial designed
Treatment Study
Phase 4
Interventional
Study Start: August 2007
Summary
Principal SponsorUniversity of Cincinnati
Last updated: January 27, 2026
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Study start date: August 1, 2007
Actual date on which the first participant was enrolled.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.
Official TitleAssessment of Seizure Prophylaxis Protocols Using Intravenous Levetiracetam in a Neuroscience Intensive Care Unit
Principal SponsorUniversity of Cincinnati
Last updated: January 27, 2026
Sourced from a government-validated database.Claim as a partner
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.Design Details
52 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Conditions
Criteria
Any sex
Biological sex of participants that are eligible to enroll.Over 18 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Brain Injuries, TraumaticBrain DiseasesBrain InjuriesCardiovascular DiseasesCentral Nervous System DiseasesCerebrovascular DisordersCraniocerebral TraumaHemorrhageNervous System DiseasesNeurologic ManifestationsPathologic ProcessesSeizuresSigns and SymptomsSubarachnoid HemorrhagePathological Conditions, Signs and SymptomsVascular DiseasesWounds and InjuriesTrauma, Nervous SystemIntracranial Hemorrhages
Criteria
15 inclusion criteria required to participate
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
Show More Criteria
12 exclusion criteria prevent from participating
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
Show More Criteria
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.Treatment Groups
Study Objectives
2 intervention groups are designated in this study
This study does not include a placebo group
Treatment Groups
Group I
Active ComparatorGroup 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.
Group II
Active ComparatorGroup 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.
Study Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location
Suspended
University of Cincinnati Hospital
Cincinnati, United StatesOpen University of Cincinnati Hospital in Google MapsCompletedOne Study Center