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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Recruitment Status : Withdrawn (no funding)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
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Subarachnoid Hemorrhage Seizures Drug: levetiracetam Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bleeding Seizures

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 Name: keppra




Primary Outcome Measures :
  1. 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)


Secondary Outcome Measures :
  1. 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)


Other Outcome Measures:
  1. 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

  2. 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



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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

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


Locations
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United States, Tennessee
Vanderbilt University Medical Center
Nashville, Tennessee, United States, 37232
Sponsors and Collaborators
Vanderbilt University Medical Center
Investigators
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Principal Investigator: J D Mocco, MS, MD Vanderbilt University
Study Director: Michael C Dewan, MD Vanderbilt University

Publications:

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Responsible Party: Vanderbilt University Medical Center
ClinicalTrials.gov Identifier: NCT01935908     History of Changes
Other Study ID Numbers: SPLASH-P1
First Posted: September 5, 2013    Key Record Dates
Last Update Posted: November 1, 2017
Last Verified: October 2017
Keywords provided by Vanderbilt University Medical Center:
Subarachnoid Hemorrhage
Seizures
Prophylaxis
Levetiracetam
Additional relevant MeSH terms:
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Seizures
Subarachnoid Hemorrhage
Hemorrhage
Pathologic Processes
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Intracranial Hemorrhages
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Levetiracetam
Anticonvulsants
Nootropic Agents