Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
University of Cincinnati
With
Mayfield Clinic & Spine Institute
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.
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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
You may not be if
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.
Clareo Health | Assess Safety and Efficacy of Levetiracetam(LEV;Keppra)for Seizure Prevention