Seizure Prophylaxis in Aneurysm Repair (SPAR)

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University of Michigan

Status and phase

Completed
Phase 4

Conditions

Seizure
Intracranial Aneurysms

Treatments

Drug: Levetiracetam

Study type

Interventional

Funder types

Other

Identifiers

NCT01801072
HUM00064523

Details and patient eligibility

About

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.

Enrollment

79 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Supportive Care

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

79 participants in 2 patient groups

Levetiracetam
Active Comparator group
Description:
500 mg intravenous dose during the operative case then 500 mg orally twice a day for a total of seven days.
Treatment:
Drug: Levetiracetam
No levetiracetam
No Intervention group
Description:
No levetiracetam

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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