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Seizure Prophylaxis in Aneurysm Repair (SPAR)
This study is currently recruiting participants.
Verified May 2017 by Aditya S. Pandey, MD, University of Michigan
Sponsor:
University of Michigan
Information provided by (Responsible Party):
Aditya S. Pandey, MD, University of Michigan
ClinicalTrials.gov Identifier:
NCT01801072
First received: February 26, 2013
Last updated: May 17, 2017
Last verified: May 2017
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Purpose
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 | Intervention | Phase |
|---|---|---|
| Intracranial Aneurysms Seizure | Drug: Levetiracetam | Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: No masking Primary Purpose: Supportive Care |
| Official Title: | Seizure Prophylaxis in Aneurysm Repair |
Resource links provided by NLM:
Further study details as provided by Aditya S. Pandey, MD, University of Michigan:
Primary Outcome Measures:
- Incidence of seizure [ Time Frame: 1 year from procedure ]
| Estimated Enrollment: | 400 |
| Study Start Date: | February 2013 |
| Estimated Study Completion Date: | February 2018 |
| Estimated Primary Completion Date: | February 2018 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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
|
Eligibility| 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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For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01801072
Please refer to this study by its ClinicalTrials.gov identifier: NCT01801072
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
| 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 |
| Study First Received: | February 26, 2013 |
| Last Updated: | May 17, 2017 |
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 |
ClinicalTrials.gov processed this record on August 16, 2017