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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Levetiracetam | Active Comparator | 500 mg intravenous dose during the operative case then 500 mg orally twice a day for a total of seven days. |
|
| No levetiracetam | No Intervention | No levetiracetam during the operative phase. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Levetiracetam | Drug | Details covered in Arm Descriptions. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Seizure | Incidence of seizure reported as number of participants who had at least one seizure within the relevant date range. Data collected at hospital discharge, 1-2 months, 4-6 months, 6-12 months, and 5 years. Data is not cumulative. Counts reflect the number of participants who experienced a seizure since their previous check-in. | 5 years from procedure |
| Measure | Description | Time Frame |
|---|---|---|
| Duration of Seizure | Duration of seizure | To compare duration of seizure in each randomization group |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Aditya S Pandey, MD | University of Michigan | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Michigan Health System | Ann Arbor | Michigan | 48109 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Levetiracetam | 500 mg intravenous dose during the operative case then 500 mg orally twice a day for a total of seven days. Levetiracetam: Details covered in Arm Descriptions. |
| FG001 | No Levetiracetam | No levetiracetam during the operative phase. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Levetiracetam | 500 mg intravenous dose during the operative case then 500 mg orally twice a day for a total of seven days. Levetiracetam: Details covered in Arm Descriptions. |
| BG001 | No Levetiracetam |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Incidence of Seizure | Incidence of seizure reported as number of participants who had at least one seizure within the relevant date range. Data collected at hospital discharge, 1-2 months, 4-6 months, 6-12 months, and 5 years. Data is not cumulative. Counts reflect the number of participants who experienced a seizure since their previous check-in. | The number of participants analyzed differs from the totals enrolled as some subjects withdrew consent after randomization or were taken out of the study due to physician decision. | Posted | Count of Participants | Participants | 5 years from procedure |
|
5 years
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Levetiracetam | 500 mg intravenous dose during the operative case then 500 mg orally twice a day for a total of seven days. Levetiracetam: Details covered in Arm Descriptions. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Acute Right Vision Loss | Eye disorders | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Unexplained Encephalopathy | Nervous system disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Aditya Pandey, Chair, Department of Neurosurgery | University of Michigan | 734-936-7010 | adityap@umich.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Dec 7, 2022 | Aug 14, 2024 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D002532 | Intracranial Aneurysm |
| D012640 | Seizures |
| ID | Term |
|---|---|
| D020765 | Intracranial Arterial Diseases |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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| ID | Term |
|---|---|
| D000077287 | Levetiracetam |
| ID | Term |
|---|---|
| D000081 | Acetamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000085 | Acetates |
| D000144 |
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| Withdrawal by Subject |
|
| Protocol Violation |
|
| Death |
|
No levetiracetam during the operative phase.
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| OG001 |
| No Levetiracetam |
No levetiracetam during the operative phase. |
|
|
| Secondary | Duration of Seizure | Duration of seizure | While this was originally intended to be a measure collected for this study, the unpredictability of seizure occurrences and the consequent challenges with observing them consistently resulted in our being unable to collect this data from participants. | Posted | To compare duration of seizure in each randomization group |
|
|
| 7 |
| 40 |
| 2 |
| 40 |
| 7 |
| 40 |
| EG001 | No Levetiracetam | No levetiracetam during the operative phase. | 8 | 42 | 2 | 42 | 3 | 42 |
| Stroke | Vascular disorders | Systematic Assessment |
|
| Headache | Nervous system disorders | Systematic Assessment |
|
| Delirium | Nervous system disorders | Systematic Assessment |
|
| Patient received extra Keppra | Product Issues | Systematic Assessment | Participant was randomized to the Keppra arm. Patient was inadvertently discharged with a 30-day supply of Keppra. Once the study team became aware of this, the patient was fully instructed how to taper off Keppra. |
|
| Seizure | Nervous system disorders | Systematic Assessment |
|
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| D009422 | Nervous System Diseases |
| D000783 | Aneurysm |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D011760 | Pyrrolidinones |
| D011759 | Pyrrolidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |