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

Jeffrey L. Saver1,700 enrolled

Overview

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.

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

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

1,700

Conditions

Cerebrovascular Accident

Interventions

Magnesium SulfateDRUG

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.

Normal SalineDRUG

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.

Eligibility

Sex: ALLMin age: 40 YearsMax age: 95 Years

Medical Language ↔ Plain English

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

Locations (1)

The Clinical Coordinating Center is: UCLA School of Medicine, 710 Westwood Plaza

Los Angeles, California, United States

Outcomes

Primary Outcomes

Modified Rankin Scale

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

Time frame: 3 months after stroke onset

Secondary Outcomes

Modified Rankin Score of 0 or 1

Minimal or no disability based on the modified Rankin score

Time frame: 3 months

Modified Rankin Score ≤2

Functional independence based on modified Rankin score

Time frame: 3 months

NIH Stroke Scale

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

Time frame: 3 months

Barthel Index

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)

Data from ClinicalTrials.gov

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