Clinical trial NCT01935908: Seizure Prophylaxis With Levetiracetam in Aneurysmal Subarachnoid Hemorrhage - Pilot Study
Official title: Pilot Study of Seizure Prophylaxis With Levetiracetam in Aneurysmal Subarachnoid Hemorrhage
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE4
Conditions: Subarachnoid Hemorrhage
Seizures
Keywords: Subarachnoid Hemorrhage
Seizures
Prophylaxis
Levetiracetam
Lead sponsor: Vanderbilt University Medical Center
Sponsor class: OTHER
First posted: 2013-09-05
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.


Eligibility criteria: 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

Primary outcomes:
measure: Randomization Yield
timeFrame: 6 months
Secondary outcomes:
measure: Protocol Adherence Yield
timeFrame: 9 months
Other outcomes:
measure: modified Rankin Scale (mRS)
timeFrame: hospital discharge, 1-month, 3-months
measure: Glasgow Outcomes Scale-Extended (GOSE)
timeFrame: hospital discharge, 1-month, 3-month
Locations:
city: Nashville
country: United States
facility: Vanderbilt University Medical Center
state: Tennessee
Study officials:
affiliation: Vanderbilt University
name: J D Mocco, MS, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Vanderbilt University
name: Michael C Dewan, MD
role: STUDY_DIRECTOR
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