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Methylprednisolone Given by 24-Hour or 48-Hour Infusion Versus Tirilazad for Acute Spinal Cord Injury

Primary Purpose

Spinal Cord Injury

Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
methylprednisolone
tirilazad
Sponsored by
National Institute of Neurological Disorders and Stroke (NINDS)
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Spinal Cord Injury focused on measuring environmental/toxic disorders, neurologic and psychiatric disorders, rare disease, spinal cord injury

Eligibility Criteria

14 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- Acute spinal cord injury; diagnosis confirmed by study physician using National Acute Spinal Cord Injury Study neurologic exam Glasgow Coma Score greater than 9 Randomization within 6 hours of injury required; treatment must begin within 8 hours of injury No root involvement only; no cauda equina only --Prior/Concurrent Therapy-- Methylprednisolone bolus (20-40 mg/kg) prior to hospital admission allowed --Patient Characteristics-- Hematopoietic: No hematologic contraindication to protocol therapy Cardiovascular: No vascular contraindication to protocol therapy Other: No diabetes; No gunshot wound; No gastrointestinal bleeding; No life-threatening co-morbidity; No other medical contraindication to protocol therapy; No pregnant women; No patients under indictment or incarcerated; No conditions that would complicate follow-up, e.g.: out-of-state residency or illegal alien status

Sites / Locations

    Outcomes

    Primary Outcome Measures

    Secondary Outcome Measures

    Full Information

    First Posted
    February 24, 2000
    Last Updated
    September 8, 2008
    Sponsor
    National Institute of Neurological Disorders and Stroke (NINDS)
    Collaborators
    Yale University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00004759
    Brief Title
    Methylprednisolone Given by 24-Hour or 48-Hour Infusion Versus Tirilazad for Acute Spinal Cord Injury
    Official Title
    Phase III Randomized, Double-Blind Study of Methylprednisolone by 24- Versus 48-Hour Infusion Versus Tirilazad for Acute Spinal Cord Injury
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2008
    Overall Recruitment Status
    Completed
    Study Start Date
    December 1991 (undefined)
    Primary Completion Date
    August 2007 (Actual)
    Study Completion Date
    undefined (undefined)

    3. Sponsor/Collaborators

    Name of the Sponsor
    National Institute of Neurological Disorders and Stroke (NINDS)
    Collaborators
    Yale University

    4. Oversight

    5. Study Description

    Brief Summary
    OBJECTIVES: I. Compare the efficacy and safety of 24- versus 48-hour infusion of methylprednisolone (MePRDL) versus tirilazad for patients with acute spinal cord injury. II. Compare neurologic recovery following 24- and 48-hour MePRDL infusions.
    Detailed Description
    PROTOCOL OUTLINE: This is a randomized, double-blind study. Patients are stratified by participating institution. Patients are randomly assigned to 1 of 3 treatment groups within 6 hours of injury. Treatment begins within 2 hours of randomization. One group receives a 24-hour methylprednisolone (MePRDL) infusion: a loading dose followed in 45 minutes by a 23-hour continuous infusion. A placebo for tirilazad is also administered. A second group receives the same MePRDL loading dose but the continuous infusion is maintained for 48 hours. A placebo for tirilazad is also administered. A third group receives a 48-hour infusion of tirilazad with an initial bolus dose of MePRDL. Eight additional doses of tirilazad are administered by intravenous push. The MePRDL loading dose may be omitted for patients who received a prestudy MePRDL dose. Patients are followed at 72 hours, 6 weeks, 6 months, and 1 year after the injury.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Spinal Cord Injury
    Keywords
    environmental/toxic disorders, neurologic and psychiatric disorders, rare disease, spinal cord injury

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 3
    Interventional Study Model
    Parallel Assignment
    Masking
    Double
    Allocation
    Randomized
    Enrollment
    497 (false)

    8. Arms, Groups, and Interventions

    Intervention Type
    Drug
    Intervention Name(s)
    methylprednisolone
    Intervention Type
    Drug
    Intervention Name(s)
    tirilazad

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    14 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- Acute spinal cord injury; diagnosis confirmed by study physician using National Acute Spinal Cord Injury Study neurologic exam Glasgow Coma Score greater than 9 Randomization within 6 hours of injury required; treatment must begin within 8 hours of injury No root involvement only; no cauda equina only --Prior/Concurrent Therapy-- Methylprednisolone bolus (20-40 mg/kg) prior to hospital admission allowed --Patient Characteristics-- Hematopoietic: No hematologic contraindication to protocol therapy Cardiovascular: No vascular contraindication to protocol therapy Other: No diabetes; No gunshot wound; No gastrointestinal bleeding; No life-threatening co-morbidity; No other medical contraindication to protocol therapy; No pregnant women; No patients under indictment or incarcerated; No conditions that would complicate follow-up, e.g.: out-of-state residency or illegal alien status
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Michael Bracken
    Organizational Affiliation
    Yale University
    Official's Role
    Study Chair

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    9817404
    Citation
    Bracken MB, Shepard MJ, Holford TR, Leo-Summers L, Aldrich EF, Fazl M, Fehlings MG, Herr DL, Hitchon PW, Marshall LF, Nockels RP, Pascale V, Perot PL Jr, Piepmeier J, Sonntag VK, Wagner F, Wilberger JE, Winn HR, Young W. Methylprednisolone or tirilazad mesylate administration after acute spinal cord injury: 1-year follow up. Results of the third National Acute Spinal Cord Injury randomized controlled trial. J Neurosurg. 1998 Nov;89(5):699-706. doi: 10.3171/jns.1998.89.5.0699.
    Results Reference
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    PubMed Identifier
    9168289
    Citation
    Bracken MB, Shepard MJ, Holford TR, Leo-Summers L, Aldrich EF, Fazl M, Fehlings M, Herr DL, Hitchon PW, Marshall LF, Nockels RP, Pascale V, Perot PL Jr, Piepmeier J, Sonntag VK, Wagner F, Wilberger JE, Winn HR, Young W. Administration of methylprednisolone for 24 or 48 hours or tirilazad mesylate for 48 hours in the treatment of acute spinal cord injury. Results of the Third National Acute Spinal Cord Injury Randomized Controlled Trial. National Acute Spinal Cord Injury Study. JAMA. 1997 May 28;277(20):1597-604.
    Results Reference
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    Methylprednisolone Given by 24-Hour or 48-Hour Infusion Versus Tirilazad for Acute Spinal Cord Injury

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