Intracranial Aneurysms, Seizures
Conditions
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.
Interventions
DRUGLevetiracetam
500 mg intravenous dose during the operative case then 500 mg orally twice a day for a total of seven days
Sponsors
Indiana University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of Seizure | 6 mo - 1 Year from Operative Procedure | Reported via patient in follow-up phone call. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Participant flow
Pre-assignment details
While 17 were consented, 3 were screen failures, 5 were lost to follow up and one was withdrawn from the study.
Participants by arm
| Arm | Count |
|---|---|
| Levetiracetam Levetiracetam: 500 mg intravenous dose during the operative case then 500 mg orally twice a day for a total of seven days | 5 |
| No Anti-epileptic Treatment | 3 |
| Total | 8 |
Baseline characteristics
| Characteristic | Levetiracetam | No Anti-epileptic Treatment | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 5 Participants | 3 Participants | 8 Participants |
| Sex: Female, Male Female | 3 Participants | 3 Participants | 6 Participants |
| Sex: Female, Male Male | 2 Participants | 0 Participants | 2 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 1 / 5 | 1 / 3 |
| serious Total, serious adverse events | 1 / 5 | 1 / 3 |
Outcome results
Primary
Incidence of Seizure
Reported via patient in follow-up phone call.
Time frame: 6 mo - 1 Year from Operative Procedure
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Levetiracetam | Incidence of Seizure | 0 participants |
| No Anti-epileptic Treatment | Incidence of Seizure | 1 participants |
Secondary
Number of Participants Who Returned to Daily Activities.
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.
Time frame: 6 months - 12 months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Levetiracetam | Number of Participants Who Returned to Daily Activities. | 5 participants |
| No Anti-epileptic Treatment | Number of Participants Who Returned to Daily Activities. | 1 participants |
Secondary
Number of Participants Who Returned to Work
The number who had returned to work in the timeframe of 6-12 months, inclusion of those that returned to part-time.
Time frame: 6 months - 12 months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Levetiracetam | Number of Participants Who Returned to Work | 1 participants |
| No Anti-epileptic Treatment | Number of Participants Who Returned to Work | 1 participants |