Seizure Prophylaxis in Aneurysm Repair

Indiana University

Status and phase: Terminated; Phase 4

Conditions: Seizures; Intracranial Aneurysms

Treatments: Drug: Levetiracetam

Study type: Interventional

Funder types: Other

Identifiers

NCT01974700

GCBS-0001

Details and patient eligibility

About

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.

Enrollment: 17 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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17 participants in 2 patient groups

Levetiracetam

Active Comparator group

Treatment:

Drug: Levetiracetam

No anti-epileptic treatment

No Intervention group