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

Phase 3

Completed

Conditions: Cerebrovascular Accident

Interventions: Drug: Normal Saline
Drug: Magnesium Sulfate

Registration Number: NCT00059332

Lead Sponsor: Jeffrey L. Saver

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 1700

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Normal saline	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.
Magnesium Sulfate	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.

Primary Outcome Measures

Name	Time	Method
Modified Rankin Scale	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

Secondary Outcome Measures

Name	Time	Method
Modified Rankin Score of 0 or 1	3 months	Minimal or no disability based on the modified Rankin score
Modified Rankin Score ≤2	3 months	Functional independence based on modified Rankin score
NIH Stroke Scale	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	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	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	3 months
Symptomatic Intracranial Hemorrhage	3 month
Mortality	3 months