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Seizure Prophylaxis With Levetiracetam in Aneurysmal Subarachnoid Hemorrhage - Pilot Study (SPLASH - Pilot)

Primary Purpose

Subarachnoid Hemorrhage, Seizures

Status
Withdrawn
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
levetiracetam
Sponsored by
Vanderbilt University Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Subarachnoid Hemorrhage focused on measuring Subarachnoid Hemorrhage, Seizures, Prophylaxis, Levetiracetam

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Vanderbilt University Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Active Comparator

Arm Label

Control Group

Treatment Group

Arm Description

The control group will not receive levetiracetam as seizure prophylaxis.

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.

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

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)

Full Information

First Posted
April 21, 2013
Last Updated
October 30, 2017
Sponsor
Vanderbilt University Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT01935908
Brief Title
Seizure Prophylaxis With Levetiracetam in Aneurysmal Subarachnoid Hemorrhage - Pilot Study
Acronym
SPLASH - Pilot
Official Title
Pilot Study of Seizure Prophylaxis With Levetiracetam in Aneurysmal Subarachnoid Hemorrhage
Study Type
Interventional

2. Study Status

Record Verification Date
October 2017
Overall Recruitment Status
Withdrawn
Why Stopped
no funding
Study Start Date
May 2013 (Actual)
Primary Completion Date
May 2013 (Actual)
Study Completion Date
May 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Vanderbilt University Medical Center

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Subarachnoid Hemorrhage, Seizures
Keywords
Subarachnoid Hemorrhage, Seizures, Prophylaxis, Levetiracetam

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control Group
Arm Type
No Intervention
Arm Description
The control group will not receive levetiracetam as seizure prophylaxis.
Arm Title
Treatment Group
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
levetiracetam
Other Intervention Name(s)
keppra
Primary Outcome Measure Information:
Title
Randomization Yield
Description
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)
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Protocol Adherence Yield
Description
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)
Time Frame
9 months
Other Pre-specified Outcome Measures:
Title
modified Rankin Scale (mRS)
Description
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
Time Frame
hospital discharge, 1-month, 3-months
Title
Glasgow Outcomes Scale-Extended (GOSE)
Description
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
Time Frame
hospital discharge, 1-month, 3-month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
J D Mocco, MS, MD
Organizational Affiliation
Vanderbilt University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Michael C Dewan, MD
Organizational Affiliation
Vanderbilt University
Official's Role
Study Director
Facility Information:
Facility Name
Vanderbilt University Medical Center
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232
Country
United States

12. IPD Sharing Statement

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Seizure Prophylaxis With Levetiracetam in Aneurysmal Subarachnoid Hemorrhage - Pilot Study

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