Not provided
Not provided
Not provided
Not provided
Not provided
Lack of enrollment - since the start of the study in 2013, only 17 subjects have consented. Of those, only 8 completed the study.
Not provided
Not provided
Not provided
Not provided
Not provided
Seizures are a potential complication of surgical repair of intracranial aneurysms. In order to prevent seizures, many surgeons administer prophylactic anti-epileptic medication during the intra-operative and post-operative period, however, such practice is not supported by clinical data. Retrospective review found the incidence of postoperative seizures was higher in those who received anti-epileptics versus those who did not. The goal is to examine the utility of levetiracetam (Keppra) for seizure prophylaxis in patients undergoing surgical repair of unruptured intracranial aneurysms.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Levetiracetam | Active Comparator |
| |
| No anti-epileptic treatment | No Intervention |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Levetiracetam | Drug | 500 mg intravenous dose during the operative case then 500 mg orally twice a day for a total of seven days |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Seizure | Reported via patient in follow-up phone call. | 6 mo - 1 Year from Operative Procedure |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Who Returned to Daily Activities. | The number who had returned to daily activities in the timeframe of 6-12 months, inclusion of those that returned to most of daily activities. | 6 months - 12 months |
| Number of Participants Who Returned to Work |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| IU Health Methodist Hospital | Indianapolis | Indiana | 46202 | United States |
While 17 were consented, 3 were screen failures, 5 were lost to follow up and one was withdrawn from the study.
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Levetiracetam | Levetiracetam: 500 mg intravenous dose during the operative case then 500 mg orally twice a day for a total of seven days |
| FG001 | No Anti-epileptic Treatment |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Levetiracetam | Levetiracetam: 500 mg intravenous dose during the operative case then 500 mg orally twice a day for a total of seven days |
| BG001 | No Anti-epileptic Treatment | |
| 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 | Reported via patient in follow-up phone call. | Posted | Number | participants | 6 mo - 1 Year from Operative Procedure |
|
|
within 1 year
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Levetiracetam | Levetiracetam: 500 mg intravenous dose during the operative case then 500 mg orally twice a day for a total of seven days |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| rehospitalization for seizures | Nervous system disorders | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| nausea | Gastrointestinal disorders | Non-systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Aaron Cohen-Gadol | Indiana University | 317-396-1300 | ACohen@goodmancampbell.com |
Not provided
| ID | Term |
|---|---|
| D002532 | Intracranial Aneurysm |
| D012640 | Seizures |
| ID | Term |
|---|---|
| D020765 | Intracranial Arterial Diseases |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D000077287 | Levetiracetam |
| ID | Term |
|---|---|
| D000081 | Acetamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000085 | Acetates |
| D000144 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The number who had returned to work in the timeframe of 6-12 months, inclusion of those that returned to part-time. |
| 6 months - 12 months |
| BG002 |
| Total |
Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
|
| Secondary | Number of Participants Who Returned to Daily Activities. | The number who had returned to daily activities in the timeframe of 6-12 months, inclusion of those that returned to most of daily activities. | Posted | Number | participants | 6 months - 12 months |
|
|
|
| Secondary | Number of Participants Who Returned to Work | The number who had returned to work in the timeframe of 6-12 months, inclusion of those that returned to part-time. | Posted | Number | participants | 6 months - 12 months |
|
|
|
| 1 |
| 5 |
| 1 |
| 5 |
| EG001 | No Anti-epileptic Treatment | 1 | 3 | 1 | 3 |
| benzodiazepine withdrawal rehospitalization | Nervous system disorders | Non-systematic Assessment |
|
| itching | General disorders | Non-systematic Assessment |
|
| intraoperative rupture | Injury, poisoning and procedural complications | Non-systematic Assessment |
|
| partial seizures | Nervous system disorders | Non-systematic Assessment |
|
Not provided
Not provided
Not provided
| 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 |