NCT01801072

Seizure Prophylaxis in Aneurysm Repair

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 82 (actual)
• Sponsor: University of Michigan · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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. The study will be extended to June 2024 to allow for a 5 year follow up of the last enrolled patient in June, 2019.

Conditions

• Intracranial Aneurysms
• Seizure

Interventions

Type	Name	Description
DRUG	Levetiracetam	Details covered in Arm Descriptions.

Timeline

• Start date: 2013-02-01
• Primary completion: 2023-10-06
• Completion: 2023-10-06
• First posted: 2013-02-28
• Last updated: 2024-11-29
• Results posted: 2024-11-29

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study