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Trial record 1 of 1 for:    NCT00059332
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Field Administration of Stroke Therapy - Magnesium (FAST-MAG) Trial (FAST-MAG)

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ClinicalTrials.gov Identifier: NCT00059332
Recruitment Status : Completed
First Posted : April 24, 2003
Results First Posted : August 21, 2015
Last Update Posted : August 21, 2015
Sponsor:
Collaborator:
National Institute of Neurological Disorders and Stroke (NINDS)
Information provided by (Responsible Party):
Jeffrey L. Saver, University of California, Los Angeles

Tracking Information
First Submitted Date  ICMJE April 23, 2003
First Posted Date  ICMJE April 24, 2003
Results First Submitted Date  ICMJE June 9, 2015
Results First Posted Date  ICMJE August 21, 2015
Last Update Posted Date August 21, 2015
Study Start Date  ICMJE January 2005
Actual Primary Completion Date March 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 24, 2015)
Modified Rankin Scale [ Time Frame: 3 months after stroke onset ]
Modified Rankin Scales (mRS) is a measure of global disability. Total Scale range is 0-6, with lower values indicating better outcomes. 0 No symptoms at all
  1. No significant disability despite symptoms; able to carry out all usual duties and activities
  2. Slight disability; unable to carry out all previous activities, but able to look after own affairs without assistance
  3. Moderate disability; requiring some help, but able to walk without assistance
  4. Moderately severe disability; unable to walk without assistance and unable to attend to own bodily needs without assistance
  5. Severe disability; bedridden, incontinent and requiring constant nursing care and attention
  6. Dead
Original Primary Outcome Measures  ICMJE Not Provided
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 24, 2015)
  • Modified Rankin Score of 0 or 1 [ Time Frame: 3 months ]
    Minimal or no disability based on the modified Rankin score
  • Modified Rankin Score ≤2 [ Time Frame: 3 months ]
    Functional independence based on modified Rankin score
  • NIH Stroke Scale [ Time Frame: 3 months ]
    The National Institute of Health Stroke Scale (NIHSS) is a measure of neurologic deficit. Total Score range 0-42, with higher scores indicating greater severity. The 11 domains assessed are: 1a-c Level of consciousness 2. Best Gaze 3. Visual 4. Facial Palsy 5a. Motor left arm 5b. Motor right arm 6a. Motor left leg 6b. Motor right leg 7. Limb Ataxia 8. Sensory 9. Best Language 10. Dysarthria 11. Extinction and Inattention
  • Barthel Index [ Time Frame: 3 months ]
    The Barthel Index is a measure of activities of daily living. Total score is calculated by addition of subscale scores. Total score range is 0-100, with higher scores indicating better outcomes. The ten subitems are: FEEDING (Subscale range is 0-10) BATHING (Subscale range is 0-5) GROOMING (Subscale range is 0-5) DRESSING (Subscale range is 0-10) BOWELS (Subscale range is 0-10) BLADDER (Subscale range is 0-10) TOILET USE (Subscale range is 0-10) TRANSFERS (Subscale range is 0-15) MOBILITY (Subscale range is 0-15) STAIRS (Subscale range is 0-10)
  • Stroke Impact Scale [ Time Frame: 3 months ]
    The Stroke Impact Scale (SIS) is a measure of stroke-specific quality of life. The scale assesses 8 domains. Scores for each domain range from 0-100, with higher scores indicating better outcomes.
    1. Physical problems
    2. Memory and thinking
    3. Mood and emotions
    4. Communication, reading and understanding
    5. Daily activities
    6. Mobility at home and in the community
    7. Affected hand use
    8. Hobbies and activities participation
  • Serious Adverse Events [ Time Frame: 3 months ]
  • Symptomatic Intracranial Hemorrhage [ Time Frame: 3 month ]
  • Mortality [ Time Frame: 3 months ]
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Field Administration of Stroke Therapy - Magnesium (FAST-MAG) Trial
Official Title  ICMJE Field Administration of Stroke Therapy-Magnesium Trial: A Randomized, Double-Blind, Placebo Controlled Trial of Neuroprotective Magnesium Sulfate Therapy for Acute Stroke Initiated Within 2 Hours of Onset by Paramedics in the Field
Brief Summary The goal of this study is to evaluate the effectiveness and safety of field-initiated magnesium sulfate in improving the long-term functional outcome of patients with acute stroke.
Detailed Description

Stroke is the third leading cause of death and the leading cause of adult disability in the United States. Each year, more than 750,000 Americans suffer a symptomatic stroke.

Currently, tissue plasminogen activator (rt-PA) is the only approved treatment for acute ischemic stroke; however, its usefulness is limited because most patients cannot reach medical attention within the necessary 3-hour time window. In addition, rt-PA cannot be given in the field because it is contraindicated for treatment of patients with brain hemorrhage.

The purpose of this multi-center, randomized, double-blind trial is to demonstrate that paramedic initiation of the neuroprotective agent magnesium sulfate in the field is an effective and safe treatment for acute stroke. This study will analyze magnesium sulfate, an experimental therapy for stroke, versus placebo among ambulance-transported patients with acute stroke. This trial will also demonstrate that paramedics can safely, effectively, and rapidly start neuroprotective therapies for stroke.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Cerebrovascular Accident
Intervention  ICMJE
  • Drug: Magnesium Sulfate
    Paramedics initiate a loading dose of 4 grams magnesium sulfate IV over 15 minutes, followed after hospital arrival by a maintenance infusion of 16 grams magnesium sulfate IV over 24 hours.
    Other Name: MA 135 magnesium sulfate heptahydrate
  • Drug: Normal Saline
    Paramedics initiate a loading dose of placebo normal saline IV over 15 minutes, followed after hospital arrival by a maintenance infusion of placebo normal saline IV over 24 hours.
    Other Name: SO155 sodium chloride
Study Arms  ICMJE
  • Experimental: Magnesium Sulfate
    Magnesium sulfate (Mg) was administered intravenously with a 15 minute bolus load followed by a 24 hour infusion. The bolus-loading dose consisted of 4 grams Mg in 54 ml normal saline. The maintenance infusion contained 16 grams Mg diluted in 240 ml 0.9% normal saline, infused at 10 ml/hr for 24 hours. Paramedics in the field initiated the bolus-loading dose, administered at 216 ml/hr over 15 minutes through a rate controlled IV infusion set. The maintenance infusion was initiated in hospital immediately upon completion of the loading dose.
    Intervention: Drug: Magnesium Sulfate
  • Placebo Comparator: Normal saline
    Normal saline was administered intravenously with a 15 minute bolus load followed by a 24 hour infusion. Paramedics in the field initiated the bolus-loading dose of 54 ml normal saline, administered at 216 ml/hr over 15 minutes through a rate controlled IV infusion set. The maintenance infusion was initiated in hospital immediately upon completion of the loading dose at 10 ml/hr for 24 hours.
    Intervention: Drug: Normal Saline
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 6, 2011)
1700
Original Enrollment  ICMJE
 (submitted: June 23, 2005)
1298
Actual Study Completion Date  ICMJE March 2013
Actual Primary Completion Date March 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Suspected stroke identified by the Los Angeles Prehospital Stroke Screen
  • Age 40-95, inclusive
  • Last known well time within 2 hours of treatment initiation
  • Deficit present for >/= 15 minutes

Exclusion Criteria:

  • Coma
  • Rapidly improving neurologic deficit
  • Pre-existing neurologic, psychiatric, or advanced systemic disease that would confound the neurological or functional outcome evaluations
  • Systolic Blood Pressure (SBP) < 90 or > 220
  • Known severe renal dysfunction (on dialysis or known chronic creatinine > 3.0)
  • Severe respiratory distress (O2 sat < 90% or respiratory rate < 12 or >/= 24)
  • Known second or third degree heart block with no pacemaker in place
  • Major head trauma in the last 24 hours
  • Recent stroke within prior 30 days
  • Patient unable to give informed consent and no available on scene consent or assent provider
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 40 Years to 95 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00059332
Other Study ID Numbers  ICMJE U01NS044364( U.S. NIH Grant/Contract )
U01NS044364 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Jeffrey L. Saver, University of California, Los Angeles
Study Sponsor  ICMJE Jeffrey L. Saver
Collaborators  ICMJE National Institute of Neurological Disorders and Stroke (NINDS)
Investigators  ICMJE
Principal Investigator: Jeffrey Saver, M.D. UCLA School of Medicine, Study Overall Principal Investigator
Principal Investigator: Sidney Starkman, M.D. UCLA Stroke Center, Co-Principal Investigator
Principal Investigator: Marc Eckstein, M.D. Los Angeles City Emergency Medical Service, Co-Principal Investigator
Principal Investigator: Samuel Stratton, MD Los Angeles and Orange County Emergency Medical Services Agencies, Co-Principal Investigator
Principal Investigator: Frank Pratt, MD Los Angeles County Emergency Medical Service, Co-Principal Investigator
PRS Account University of California, Los Angeles
Verification Date June 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP