Study Stopped
Lack of enrollment - since the start of the study in 2013, only 17 subjects have consented. Of those, only 8 completed the study.
Seizure Prophylaxis in Aneurysm Repair
1 other identifier
interventional
17
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_4
Started Jul 2013
Typical duration for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2013
CompletedFirst Submitted
Initial submission to the registry
October 28, 2013
CompletedFirst Posted
Study publicly available on registry
November 1, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2016
CompletedResults Posted
Study results publicly available
March 11, 2016
CompletedMarch 11, 2016
March 1, 2016
2.6 years
October 28, 2013
March 7, 2016
March 7, 2016
Conditions
Outcome Measures
Primary Outcomes (1)
Incidence of Seizure
Reported via patient in follow-up phone call.
6 mo - 1 Year from Operative Procedure
Secondary Outcomes (2)
Number of Participants Who Returned to Daily Activities.
6 months - 12 months
Number of Participants Who Returned to Work
6 months - 12 months
Study Arms (2)
Levetiracetam
ACTIVE COMPARATORNo anti-epileptic treatment
NO INTERVENTIONInterventions
500 mg intravenous dose during the operative case then 500 mg orally twice a day for a total of seven days
Eligibility Criteria
You may qualify if:
- Adult (≥18 years)
- Presence of intracranial aneurysm (without rupture)
- Treating surgeon has recommended surgical repair of the aneurysm.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
IU Health Methodist Hospital
Indianapolis, Indiana, 46202, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Dr. Aaron Cohen-Gadol
- Organization
- Indiana University
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 28, 2013
First Posted
November 1, 2013
Study Start
July 1, 2013
Primary Completion
February 1, 2016
Study Completion
February 1, 2016
Last Updated
March 11, 2016
Results First Posted
March 11, 2016
Record last verified: 2016-03