Seizure Prophylaxis in Aneurysm Repair (SPAR)

Study Description

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Brief 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.

Condition or disease	Intervention/treatment	Phase
Intracranial Aneurysms; Seizure	Drug: Levetiracetam	Phase 4

Study Design

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Study Type :	Interventional (Clinical Trial)
Estimated Enrollment :	400 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	None (Open Label)
Primary Purpose:	Supportive Care
Official Title:	Seizure Prophylaxis in Aneurysm Repair
Study Start Date :	February 2013
Estimated Primary Completion Date :	February 2020
Estimated Study Completion Date :	February 2020

Arms and Interventions

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Arm	Intervention/treatment
Active Comparator: Levetiracetam; 500 mg intravenous dose during the operative case then 500 mg orally twice a day for a total of seven days.	Drug: Levetiracetam; Details covered in Arm Descriptions.; Other Name: Keppra
No Intervention: No levetiracetam; No levetiracetam

Outcome Measures

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Primary Outcome Measures :

1. Incidence of seizure [ Time Frame: 1 year from procedure ]

Eligibility Criteria

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Ages Eligible for Study:	18 Years and older (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Contacts

Contact: Aditya Pandey, MD	734-615-4486	adityap@med.umich.edu
Contact: Ron Ball	734-647-5436	rmball@med.umich.edu

Locations

United States, Michigan
University of Michigan Health System	Recruiting
Ann Arbor, Michigan, United States, 48109
Principal Investigator: Aditya Pandey, MD
Sub-Investigator: Wajd Al-Holou, MD
Sub-Investigator: Cormac Maher, MD
Sub-Investigator: Christopher Roark, MD
Sub-Investigator: William Stetler Jr, MD
Sub-Investigator: Jennifer Strahle, MD
Sub-Investigator: Byron Thompson, MD
Sub-Investigator: TJ Wilson, MD

Sponsors and Collaborators

University of Michigan

Investigators

Principal Investigator:	Aditya S Pandey, MD	University of Michigan

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party:	Aditya S. Pandey, MD, Assistant Professor of Neurosurgery and Assistant Professor of Radiology, Medical School, University of Michigan
ClinicalTrials.gov Identifier:	NCT01801072 History of Changes
Other Study ID Numbers:	HUM00064523
First Posted:	February 28, 2013
Last Update Posted:	February 27, 2018
Last Verified:	February 2018

Additional relevant MeSH terms:

Epilepsy; Aneurysm; Seizures; Intracranial Aneurysm; Vascular Diseases; Cardiovascular Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurologic Manifestations	Signs and Symptoms; Intracranial Arterial Diseases; Cerebrovascular Disorders; Etiracetam; Piracetam; Anticonvulsants; Nootropic Agents; Neuroprotective Agents; Protective Agents; Physiological Effects of Drugs