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Our primary objective is to compare two treatment options for prevention of seizures following a subarachnoid hemorrhage and determine if a short-course regimen of levetiracetam is as efficacious in the prevention of in-hospital seizures when compared to an extended course.
This is a prospective, single-center, randomized, controlled trial. Patients admitted with spontaneous SAH (and meet enrollment criteria) will be randomized to either levetiracetam 1000 mg twice daily for 3 days or levetiracetam 1000mg twice daily until hospital discharge.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Brief LEV | Other | Administration of three days of levetiracetam twice daily after SAH |
|
| Extended LEV | Other | Administration of levetiracetam twice daily after SAH |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Brief LEV | Other | Levetiracetam 1000mg BID x 3 days for prophylaxis |
| |
| Measure | Description | Time Frame |
|---|---|---|
| In-hospital Seizures | from admission to In-hospital seizures after aSAH | from hospital admission to hospital discharge |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Theresa Human-Murphy | Barnes-Jewish Hospital, Washington University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Barnes-jewish Hospital | St Louis | Missouri | 63110 | United States |
All patients enrolled were assigned to a treatment group.
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| ID | Title | Description |
|---|---|---|
| FG000 | Levetiracetam 1000mg BID for 3 Days | Levetiracetam short course: Levetiracetam 1000mg BID x 3 days This cohort will receive three days of Levetiracetam twice daily for seizure prophylaxis. They will be followed for the entire hospital stay for incidence of seizures. If a seizure occurs, the treating physician will treat per usual therapies. Functional status will be assessed at the patients outpatient follow up if available. |
| FG001 | Levetiracetam 1000mg BID x Hospital Stay | Levetiracetam Long course: Levetiracetam 1000mg BID x hospital stay This cohort will receive Levetiracetam for the entire length of hospital stay. They will be closely followed for both incidence of seizures as well as adverse effects of the medication. Functional status will be assessed at the patients outpatient follow up if available. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Brief LEV | 3 days of LEV 1000mg after aSAH |
| BG001 | Extended LEV | LEV for hospital stay after aSAH |
| 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 | In-hospital Seizures | from admission to In-hospital seizures after aSAH | Posted | Count of Participants | Participants | from hospital admission to hospital discharge |
|
from admission, daily until hosptial discharge.
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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 | Brief LEV | ADR requiring discontinuation |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Sedation | Nervous system disorders | Systematic Assessment | Excessive Sedation |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| thrombocytopenia | Immune system disorders | Systematic Assessment |
We were unable to achieve our target sample size due to slow enrollment. Secondly, the study was not blinded for the primary outcome which could introduce bias.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr Theresa Human | Washington University | 314-747-8799 | theresa.human@bjc.org |
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| ID | Term |
|---|---|
| D013345 | Subarachnoid Hemorrhage |
| ID | Term |
|---|---|
| D020300 | Intracranial Hemorrhages |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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| Extended LEV |
| Other |
Levetiracetam 1000mg BID for length of hospital stay for prophylaxis |
|
| BG002 |
| Total |
Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Units |
|---|
| Counts |
|---|
| Participants |
|
|
| 0 |
| 35 |
| 0 |
| 35 |
| EG001 | Extended LEV | ADR requiring discontinue | 4 | 49 | 1 | 49 |
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| D009422 | Nervous System Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D006470 | Hemorrhage |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |