drugset / Trial / NCT01801072

Seizure Prophylaxis in Aneurysm Repair

NCT01801072

Phase 4 Completed 82 enrolled University of Michigan
RandomizedParallel-groupOpen-labelSupportive care

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.

Timeline

Start
2013-02
Primary completion
2023-10-06
Completion
2023-10-06

Drugs

EvaluationDrugModalityDoseRoute
Comparator Levetiracetam Other / unclassified 500 mg Intravenous

Indications