Seizures, Subarachnoid Hemorrhage
Conditions
Keywords
Subarachnoid Hemorrhage, Seizures, Prophylaxis, Levetiracetam
Brief summary
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.
Interventions
DRUGlevetiracetam
Sponsors
Vanderbilt University Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Randomization Yield | 6 months | 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) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Protocol Adherence Yield | 9 months | 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) |
Other
| Measure | Time frame | Description |
|---|---|---|
| modified Rankin Scale (mRS) | hospital discharge, 1-month, 3-months | mRS - modified Rankin Scale (0-6): 0 - no symptoms 1. \- no significant disability. Able to carry out all usual activities, despite some symptoms 2. \- slight disability. Able to look after own affairs without assistance, but unable to carry out all previous activities 3. \- moderate disability. Requires some help, but able to walk unassisted. 4. \- moderately severe disability. Unable to attend to own bodily needs without assistance, and unable to walk unassisted. 5. \- Severe disability. Requires constant nursing care and attention, bedridden, incontinent. 6. \- dead |
| Glasgow Outcomes Scale-Extended (GOSE) | hospital discharge, 1-month, 3-month | GOSE - Glasgow Outcomes Scale - Extended (1-8): 1. \- death 2. \- vegetative state 3. \- lower severe disability 4. \- upper severe disability 5. \- lower moderate disability 6. \- upper moderate disability 7. \- lower good recovery 8. \- upper good recovery |
Countries
United States
Outcome results
None listed