Seizure Prophylaxis With Levetiracetam in Aneurysmal Subarachnoid Hemorrhage - Pilot Study

Phase 4

Withdrawn

• Conditions: Subarachnoid Hemorrhage; Seizures
• Interventions: Drug: levetiracetam

• Registration Number: NCT01935908
• Lead Sponsor: Vanderbilt University Medical Center

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2013-04-21
• Study Start: 2013-05
• Primary Completion: 2013-05
• Study Completion: 2013-05
• Study First Submitted QC: 2013-09-01
• Study First Posted: 2013-09-05
• Status Verified: 2017-10
• Last Update Submitted: 2017-10-30
• Last Update Posted: 2017-11-01

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Treatment Group	levetiracetam	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.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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)

Trial Locations

Locations (1)

Vanderbilt University Medical Center; 🇺🇸 Nashville, Tennessee, United States