Field Administration of Stroke Therapy - Magnesium (FAST-MAG) Trial (FAST-MAG)
|Cerebrovascular Accident||Drug: Magnesium Sulfate Drug: Normal Saline||Phase 3|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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|
- 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
- No significant disability despite symptoms; able to carry out all usual duties and activities
- Slight disability; unable to carry out all previous activities, but able to look after own affairs without assistance
- Moderate disability; requiring some help, but able to walk without assistance
- Moderately severe disability; unable to walk without assistance and unable to attend to own bodily needs without assistance
- Severe disability; bedridden, incontinent and requiring constant nursing care and attention
- 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.
- Physical problems
- Memory and thinking
- Mood and emotions
- Communication, reading and understanding
- Daily activities
- Mobility at home and in the community
- Affected hand use
- Hobbies and activities participation
- Serious Adverse Events [ Time Frame: 3 months ]
- Symptomatic Intracranial Hemorrhage [ Time Frame: 3 month ]
- Mortality [ Time Frame: 3 months ]
|Study Start Date:||January 2005|
|Study Completion Date:||March 2013|
|Primary Completion Date:||March 2013 (Final data collection date for primary outcome measure)|
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
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00059332
|United States, California|
|The Clinical Coordinating Center is: UCLA School of Medicine, 710 Westwood Plaza|
|Los Angeles, California, United States, 90095|
|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|