Seizure Prophylaxis in Aneurysm Repair

HUM00064523

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.

2013-02-01

2023-10-06

2023-10-06

Completed

Early phase I

79

Inclusion Criteria: * Adult (≥18 years) * Presence of intracranial aneurysm (with or without rupture) * Treating surgeon has recommended surgical repair of the aneurysm Exclusion Criteria: * History of seizures within last 10 years * History of epilepsy * History of prior stroke * Currently prescribed medication with anti-epileptic activity (keppra, dilantin, tegretol, lamictal, topamax, etc.) * Brain tumor * Pregnant or nursing woman * Known levetiracetam allergy

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'SUPPORTIVE_CARE', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 79, 'type': 'ACTUAL'}}

2023-12-19