Paramedics apply ‘FAST-MAG’ test trial during transport
By Elise Kleeman
Whittier Daily News
Copyright 2007 MediaNews Group, Inc. and Los Angeles Newspaper Group, Inc.
All Rights Reserved
WHITTIER, Calif. — A study testing a new treatment for stroke victims is being expanded to include patients who cannot give immediate consent.
The countywide trial, Field Administration of Stroke Therapy-Magnesium, or FAST-MAG, tests whether an infusion of magnesium into the blood stream within two hours of a stroke will improve a patient’s outcome.
Over the past three years, 440 stoke victims have participated in the study, starting even as paramedics rushed them to the hospital.
Expanding it to include patients who could not give consent and were not accompanied by a parent, spouse or adult child would allow more patients with severe strokes to be treated and would expand the study pool, said Sidney Starkman, a UCLA neurologist and one of the study leaders.
That 10 percent to 20 percent increase in trial subjects could save valuable months of research, he said.
“If we can finish the study in three years instead of four years, that’s one more year that we can have a therapy for stroke - great!” Starkman said.
Strokes are the third highest cause of death in the United States.
The most telling sign of stroke is sudden numbness or weakness of the face, arm or leg, especially on one side of the body. They can also cause confusion, trouble speaking, understanding, seeing and walking.
To be included in the study, patients will still need to be accompanied by a family member, close friend or co-worker who knows their medical history and could give their approval, he said. Patients would be given the chance to opt out of the study as soon as they are able.
A free, public meeting will be held at Huntington Hospital in Pasadena from noon to 1 p.m. today to answer questions about the FAST-MAG trial.
Huntington Hospital, along with 42 other hospitals in Los Angeles County, already participates in the study with patients or their immediate family members who are able to give their informed consent.
“We haven’t decided as to whether we are going to participate yet” in the expanded, deferred-consent portion of the study, said Elizabeth Mullikin, executive director of the hospital’s neurosciences service line.
A hospital internal review board will meet to consider the risks and benefits within a month’s time, she said.
The need for a study like this one is great, though.
“We’re really limited in how we can treat stroke, and this study is designed to offer patients more than one type of treatment,” Mullikin said.
Only the clot-busting drug tPA, short for tissue plasminogen activator, has been proven to help stroke victims.
Its benefits are limited, though, by the fact that it must be administered within three hours of a stroke’s onset and can only be used to treat strokes caused by blood clots, not those from hemorrhages.
“People estimate that no more than 2 to 5 percent of all stroke patients get tPA,” Starkman said.
Other studies using magnesium have suggested it could have a small to moderate impact on stroke outcomes, and could be paired with other treatments. However, those early trials were hampered by small size or a long lag time between the patient’s stroke and when treatment could be started.
This is the first to put the magnesium infusion into paramedics’ hands, allowing patients to be treated much more quickly.
In animals, boosted magnesium levels have been shown to dilate blood vessels and prevent the buildup of damaging calcium in nerve cells, halving the destruction the stroke causes.
Although at high doses magnesium can cause weakness or low blood pressure, Starkman said, the amounts used for the trial are much lower.
“The only side effect really that people get is about oh, maybe 2 percent, maybe up to 5 percent, feel a little bit flushed, a little bit warm when the magnesium goes in,” he said.
The information session will be held at Huntington’s Research Conference Hall, 734 Fairmount Ave.
For more information, visit www.fastmag.info, or call Huntington’s Clinical Coordinating Center, (310) 794-6160.