Seizure Prophylaxis With Levetiracetam in Aneurysmal Subarachnoid Hemorrhage - Pilot Study

Study Overview
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Brief Summary
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The purpose of this study is to determine the feasibility of prospectively enrolling and randomizing patients with aneurysmal subarachnoid hemorrhage (aSAH) to receive levetiracetam or not to receive levetiracetam, and documenting in-hospital and follow-up clinical variables.

Official Title
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Pilot Study of Seizure Prophylaxis With Levetiracetam in Aneurysmal Subarachnoid Hemorrhage

Conditions
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Subarachnoid Hemorrhage, Seizures

Intervention / Treatment
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* Drug: levetiracetam


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: ≥ 18 years of age ≤ 75 years of age Newly diagnosed aneurysmal subarachnoid hemorrhage Exclusion Criteria: One or more antiepileptic medication is taken as a pre-admission medication Seizure occurrence in the field or in the emergency department, or anytime before consent could be obtained Inability to obtain informed consent from the patient, or from the patient's appropriate surrogate

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control Group<br>The control group will not receive levetiracetam as seizure prophylaxis. | |
| Active Comparator: Treatment Group<br>levetiracetam 500mg in adults, twice daily, administered by mouth, per tube, or IV. The route of administration will be dependent upon the patient's clinical status and ability to tolerate each form. In descending order of preference, route of administration will be: oral, per tube, IV. | Drug: levetiracetam<br> <br> * Other names: keppra;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Randomization Yield | The primary outcome will be the number of patients randomized to either levetiracetam administration or no administration of levetiracetam divided by the total number of aneurysmal subarachnoid hemorrhage patients who present to the Vanderbilt University Emergency Department or are directly admitted to the Neuro Intensive Care Unit. (Unit of Measure: numeric fraction) | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Protocol Adherence Yield | The Protocol Adherence Yield is calculated by dividing the number of patients completing the study without incurring a protocol deviation by the total number of patients randomized. (Unit of Measure: numeric fraction) | 9 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Subarachnoid Hemorrhage, Seizures, Prophylaxis, Levetiracetam