Seizure Prophylaxis in Aneurysm Repair

Phase 4

Terminated

• Conditions: Seizures; Intracranial Aneurysms
• Interventions: Drug: Levetiracetam

• Registration Number: NCT01974700
• Lead Sponsor: Indiana University

Brief Summary

Seizures are a potential complication of surgical repair of intracranial aneurysms. In order to prevent seizures, many surgeons administer prophylactic anti-epileptic medication during the intra-operative and post-operative period, however, such practice is not supported by clinical data. Retrospective review found the incidence of postoperative seizures was higher in those who received anti-epileptics versus those who did not. The goal is to examine the utility of levetiracetam (Keppra) for seizure prophylaxis in patients undergoing surgical repair of unruptured intracranial aneurysms.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-07
• Study First Submitted: 2013-10-28
• Study First Submitted QC: 2013-10-28
• Study First Posted: 2013-11-01
• Primary Completion: 2016-02
• Study Completion: 2016-02
• Status Verified: 2016-03
• Results First Submitted: 2016-03-07
• Results First Submitted QC: 2016-03-07
• Last Update Submitted: 2016-03-07
• Results First Posted: 2016-03-11
• Last Update Posted: 2016-03-11

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 17

Inclusion Criteria

1. Adult (≥18 years)
2. Presence of intracranial aneurysm (without rupture)
3. Treating surgeon has recommended surgical repair of the aneurysm.

Exclusion Criteria

1. History of seizures within last 10 years
2. History of epilepsy
3. History of prior stroke
4. Currently prescribed medication with anti-epileptic activity (keppra,dilantin, tegretol, lamictal, topamax, etc.)
5. Brain tumor
6. Pregnant or nursing woman
7. Known levetiracetam allergy

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Levetiracetam	Levetiracetam	-

Primary Outcome Measures

Name	Time	Method
Incidence of Seizure	6 mo - 1 Year from Operative Procedure	Reported via patient in follow-up phone call.

Secondary Outcome Measures

Name	Time	Method
Number of Participants Who Returned to Daily Activities.	6 months - 12 months	The number who had returned to daily activities in the timeframe of 6-12 months, inclusion of those that returned to most of daily activities.
Number of Participants Who Returned to Work	6 months - 12 months	The number who had returned to work in the timeframe of 6-12 months, inclusion of those that returned to part-time.

Trial Locations

Locations (1)

IU Health Methodist Hospital; 🇺🇸 Indianapolis, Indiana, United States