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

October 30, 2017 updated by: Vanderbilt University Medical Center

Pilot Study of Seizure Prophylaxis With Levetiracetam in Aneurysmal Subarachnoid Hemorrhage

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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Tennessee
      • Nashville, Tennessee, United States, 37232
        • Vanderbilt University Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.
Drug: levetiracetam
Other Names:
  • keppra

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
9 months

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
modified Rankin Scale (mRS)
Time Frame: 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
hospital discharge, 1-month, 3-months
Glasgow Outcomes Scale-Extended (GOSE)
Time Frame: 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
hospital discharge, 1-month, 3-month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Vanderbilt University Medical Center

Investigators

  • Principal Investigator: J D Mocco, MS, MD, Vanderbilt University
  • Study Director: Michael C Dewan, MD, Vanderbilt University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 1, 2013

Primary Completion (Actual)

May 1, 2013

Study Completion (Actual)

May 1, 2013

Study Registration Dates

First Submitted

April 21, 2013

First Submitted That Met QC Criteria

September 1, 2013

First Posted (Estimate)

September 5, 2013

Study Record Updates

Last Update Posted (Actual)

November 1, 2017

Last Update Submitted That Met QC Criteria

October 30, 2017

Last Verified

October 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SPLASH-P1

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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