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Assess the Safety and Efficacy of a Seizure Medication,Levetiracetam(LEV;Keppra),in Neuroscience Intensive Care Unit Patients

Information source: Mayfield Clinic & Spine Institute
Information obtained from ClinicalTrials.gov on November 03, 2008
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Traumatic Brain Injury; Subarachnoid Hemorrhage

Intervention: Levetiracetam (Drug); Phenytoin (Drug)

Phase: N/A

Status: Recruiting

Sponsored by: Mayfield Clinic & Spine Institute

Official(s) and/or principal investigator(s):
Lori Shutter, MD, Principal Investigator, Affiliation: Mayfield Clinic Inc

Overall contact:
Lori Shutter, MD, Phone: 1-513-584-8072, Email: shuttel@healthall.com

Summary

To show that the use of intravenous levitiracetam(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.

Clinical Details

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

Study design: Treatment, Randomized, Single Blind (Outcomes Assessor), Active Control, Parallel Assignment, Safety/Efficacy Study

Primary outcome: Seizure frequency

Secondary outcome:

Extended GOSE

Disability Rating Scale

Incidence of adverse events

Detailed description: To show that the use of intravenous levitiracetam(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

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria:

Subjects with traumatic brain injury:

- 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 >90mmHg

- At least one reactive pupil

- A negative pregnancy test in females

- Age at least 18 years

- Signed informed consent and HIPAA authorization for research form OR Subjects with

subarachnoid hemorrhage

- SAH documented by CT scan

- Hunt-Hess grade 3-5, inclusive

- Hemodynamically stable with a systolic BP> 90mmHg

- At least one reactive pupil

- A negative pregnany test in females

- Age of at least 18 years

- Signed informed consent and HIPAA authorization for research form

Locations and Contacts

Lori Shutter, MD, Phone: 1-513-584-8072, Email: shuttel@healthall.com

University of Cincinnati Hospital, Cincinnati, Ohio 45220, United States; Recruiting
Suzanne Kempisty, RN, Phone: 513-558-3590, Email: kempiss@ucmail.uc.edu
Additional Information

Starting date: August 2007
Ending date: March 2010
Last updated: February 19, 2008

Page last updated: November 03, 2008

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