An initial pilot study, conducted between May 2000 and January 2002, showed promising results. Paramedics in the field initiated the drug much more quickly, rather than waiting until the patient was in the hospital, as is the usual approach, and patients showed a tendency toward better recovery.
"The pilot trial showed that paramedics can recognize stroke accurately and safely start magnesium sulfate in the field," said Dr. Sidney Starkman, professor of emergency medicine and neurology at the Geffen School of Medicine and a co-principal investigator on the study. "Now we need to perform the large pivotal trial to determine definitively if early magnesium sulfate improves patient outcome."
Now that initial safety experience has been gained, the study is being expanded to include more patients with severe strokes, including those who cannot give their informed consent.
"These are the patients who are in greatest need of a beneficial stroke treatment," said Dr. Marc Eckstein, medical director of the Los Angeles Fire Department and a co-principal investigator on the study.
Stroke is the third leading cause of death and the leading cause of disability in the United States. More than 700,000 Americans suffer a stroke each year. Available treatments for stroke currently benefit fewer than one in 100 patients.
The FAST-MAG trial is being performed in conjunction with paramedics from 29 provider agencies in Los Angeles County. All medical directors of emergency medicine departments, neurologists and neurosurgeons in the county are being invited to join the trial as site investigators. A core group of 16 full-time study nurse research coordinators is available to provide paramedic and nursing education and to assist study hospitals with study implementation.
|Contact: Amy Albin|
University of California - Los Angeles