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

NCT00059332 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1700

Last updated 2015-08-21

Study results available
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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.

Conditions

  • Cerebrovascular Accident

Interventions

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.

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.

Sponsors & Collaborators

  • National Institute of Neurological Disorders and Stroke (NINDS)

    collaborator NIH

  • Jeffrey L. Saver

    lead OTHER

Principal Investigators

  • Jeffrey Saver, M.D. · UCLA School of Medicine, Study Overall Principal Investigator

  • Sidney Starkman, M.D. · UCLA Stroke Center, Co-Principal Investigator

  • Marc Eckstein, M.D. · Los Angeles City Emergency Medical Service, Co-Principal Investigator

  • Samuel Stratton, MD · Los Angeles and Orange County Emergency Medical Services Agencies, Co-Principal Investigator

  • Frank Pratt, MD · Los Angeles County Emergency Medical Service, Co-Principal Investigator

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
40 Years
Max Age
95 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2005-01-31
Primary Completion
2013-03-31
Completion
2013-03-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00059332 on ClinicalTrials.gov