Seizure Prophylaxis With Levetiracetam in Aneurysmal Subarachnoid Hemorrhage - Pilot Study (SPLASH - Pilot)
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|ClinicalTrials.gov Identifier: NCT01935908|
Recruitment Status : Withdrawn (no funding)
First Posted : September 5, 2013
Last Update Posted : November 1, 2017
|Condition or disease||Intervention/treatment||Phase|
|Subarachnoid Hemorrhage Seizures||Drug: levetiracetam||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||0 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Supportive Care|
|Official Title:||Pilot Study of Seizure Prophylaxis With Levetiracetam in Aneurysmal Subarachnoid Hemorrhage|
|Actual Study Start Date :||May 2013|
|Actual Primary Completion Date :||May 2013|
|Actual Study Completion Date :||May 2013|
No Intervention: Control Group
The control group will not receive levetiracetam as seizure prophylaxis.
Active Comparator: Treatment Group
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.
Other Name: keppra
- Randomization Yield [ Time Frame: 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)
- Protocol Adherence Yield [ Time Frame: 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)
- modified Rankin Scale (mRS) [ Time Frame: hospital discharge, 1-month, 3-months ]
mRS - modified Rankin Scale (0-6): 0 - no symptoms
- - no significant disability. Able to carry out all usual activities, despite some symptoms
- - slight disability. Able to look after own affairs without assistance, but unable to carry out all previous activities
- - moderate disability. Requires some help, but able to walk unassisted.
- - moderately severe disability. Unable to attend to own bodily needs without assistance, and unable to walk unassisted.
- - Severe disability. Requires constant nursing care and attention, bedridden, incontinent.
- - dead
- Glasgow Outcomes Scale-Extended (GOSE) [ Time Frame: hospital discharge, 1-month, 3-month ]
GOSE - Glasgow Outcomes Scale - Extended (1-8):
- - death
- - vegetative state
- - lower severe disability
- - upper severe disability
- - lower moderate disability
- - upper moderate disability
- - lower good recovery
- - upper good recovery
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01935908
|United States, Tennessee|
|Vanderbilt University Medical Center|
|Nashville, Tennessee, United States, 37232|
|Principal Investigator:||J D Mocco, MS, MD||Vanderbilt University|
|Study Director:||Michael C Dewan, MD||Vanderbilt University|