Seizure Prophylaxis in Aneurysm Repair (SPAR)
After a thorough review of the existing literature as well as a review of our own practice, the investigators have concluded that the decision to treat patients undergoing aneurysm repair with levetiracetam has reached true clinical equipoise. In other words, the investigators cannot favor a decision to either administer or not administer this drug in these patients based on the existing information. The utility of anti-epileptic prophlaxis in the perioperative period for patients undergoing intracranial aneurysm repair remains a common practice that is not supported by the current literature that includes retrospective analyses as well as prospective trials for similar but not identical types of patients. The investigators propose to settle this dilemma by performing a prospective randomized trial in patients undergoing aneurysm repair in order to definitively determine if the common practice of perioperative antiepileptic drug administration has any utility.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
|Official Title:||Seizure Prophylaxis in Aneurysm Repair|
- Incidence of seizure [ Time Frame: 1 year from procedure ] [ Designated as safety issue: Yes ]
|Study Start Date:||February 2013|
|Estimated Study Completion Date:||February 2015|
|Estimated Primary Completion Date:||February 2015 (Final data collection date for primary outcome measure)|
Active Comparator: Levetiracetam
500 mg intravenous dose during the operative case then 500 mg orally twice a day for a total of seven days.
Details covered in Arm Descriptions.
Other Name: Keppra
No Intervention: No levetiracetam
|Contact: Aditya Pandey, MD||734-615-4486|
|United States, Michigan|
|University of Michigan Health System||Recruiting|
|Ann Arbor, Michigan, United States, 48109|
|Principal Investigator: Aditya Pandey, MD|
|Principal Investigator:||Aditya S Pandey, MD||University of Michigan|