Seizure Prophylaxis in Aneurysm Repair

Intracranial Aneurysms Clinical Trial

— SPAR  

Official title:

Seizure Prophylaxis in Aneurysm Repair

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01801072
• Other study ID #: HUM00064523
• Status: Completed
• Phase: Phase 4
• Start date: February 2013
• Est. completion date: October 6, 2023

Study information

• Verified date: December 2023
• Source: University of Michigan
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

After a thorough review of the existing literature as well as a review of our own practice, the investigators have concluded that the decision to treat patients undergoing aneurysm repair with levetiracetam has reached true clinical equipoise. In other words, the investigators cannot favor a decision to either administer or not administer this drug in these patients based on the existing information. The utility of anti-epileptic prophlaxis in the perioperative period for patients undergoing intracranial aneurysm repair remains a common practice that is not supported by the current literature that includes retrospective analyses as well as prospective trials for similar but not identical types of patients. The investigators propose to settle this dilemma by performing a prospective randomized trial in patients undergoing aneurysm repair in order to definitively determine if the common practice of perioperative antiepileptic drug administration has any utility. The study will be extended to June 2024 to allow for a 5 year follow up of the last enrolled patient in June, 2019.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 79
• Est. completion date: October 6, 2023
• Est. primary completion date: October 6, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Adult (=18 years)

• Presence of intracranial aneurysm (with or without rupture)

• Treating surgeon has recommended surgical repair of the aneurysm

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Aneurysm
• Intracranial Aneurysm
• Intracranial Aneurysms
• Seizure
• Seizures

Intervention

Drug:
• Levetiracetam
Details covered in Arm Descriptions.

Locations

Country	Name	City	State
United States	University of Michigan Health System	Ann Arbor	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
University of Michigan

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of seizure	Incidence of seizure - data collected at 2 months, 6 months, 12 months, and 5 years.	5 years from procedure