Field Administration of Stroke Therapy - Magnesium (FAST-MAG) Trial

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Jeffrey L. Saver, University of California, Los Angeles
ClinicalTrials.gov Identifier:
NCT00059332
First received: April 23, 2003
Last updated: July 24, 2015
Last verified: June 2015
  Purpose

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.


Condition Intervention Phase
Cerebrovascular Accident
Drug: Magnesium Sulfate
Drug: Normal Saline
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by University of California, Los Angeles:

Primary Outcome Measures:
  • Modified Rankin Scale [ Time Frame: 3 months after stroke onset ] [ Designated as safety issue: No ]

    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


Secondary Outcome Measures:
  • Modified Rankin Score of 0 or 1 [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    Minimal or no disability based on the modified Rankin score

  • Modified Rankin Score ≤2 [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    Functional independence based on modified Rankin score

  • NIH Stroke Scale [ Time Frame: 3 months ] [ Designated as safety issue: No ]

    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 ] [ Designated as safety issue: No ]

    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 ] [ Designated as safety issue: No ]

    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 ] [ Designated as safety issue: Yes ]
  • Symptomatic Intracranial Hemorrhage [ Time Frame: 3 month ] [ Designated as safety issue: Yes ]
  • Mortality [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]

Enrollment: 1700
Study Start Date: January 2005
Study Completion Date: March 2013
Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
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
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.
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

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.

  Eligibility

Ages Eligible for Study:   40 Years to 95 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00059332

Locations
United States, California
The Clinical Coordinating Center is: UCLA School of Medicine, 710 Westwood Plaza
Los Angeles, California, United States, 90095
Sponsors and Collaborators
Jeffrey L. Saver
Investigators
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
  More Information

Additional Information:
No publications provided by University of California, Los Angeles

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Jeffrey L. Saver, Professor of Neurology, University of California, Los Angeles
ClinicalTrials.gov Identifier: NCT00059332     History of Changes
Other Study ID Numbers: U01NS44364, U01NS044364
Study First Received: April 23, 2003
Results First Received: June 9, 2015
Last Updated: July 24, 2015
Health Authority: United States: Food and Drug Administration

Keywords provided by University of California, Los Angeles:
stroke
brain attack
magnesium sulfate
neuroprotection
prehospital care
emergency medical services

Additional relevant MeSH terms:
Cerebral Infarction
Stroke
Brain Diseases
Brain Infarction
Brain Ischemia
Cardiovascular Diseases
Central Nervous System Diseases
Cerebrovascular Disorders
Nervous System Diseases
Vascular Diseases
Magnesium Sulfate
Analgesics
Anesthetics
Anti-Arrhythmia Agents
Anticonvulsants
Calcium Channel Blockers
Cardiovascular Agents
Central Nervous System Agents
Central Nervous System Depressants
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Reproductive Control Agents
Sensory System Agents
Therapeutic Uses
Tocolytic Agents

ClinicalTrials.gov processed this record on August 30, 2015