Seizure Prophylaxis in Aneurysm Repair

Study Results

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE4

Total Enrollment

17 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-07-31

Study Completion Date

2016-02-29

Brief Summary

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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.

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Detailed Description

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Conditions

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Intracranial Aneurysms Seizures

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Levetiracetam

Group Type ACTIVE_COMPARATOR

Levetiracetam

Intervention Type DRUG

500 mg intravenous dose during the operative case then 500 mg orally twice a day for a total of seven days

No anti-epileptic treatment

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Levetiracetam

500 mg intravenous dose during the operative case then 500 mg orally twice a day for a total of seven days

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No