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Stroke study to add patients who cannot give immediate consent
Date:11/29/2007

A Los Angeles countywide research study examining whether magnesium sulfate can protect stroke victims' brains when administered by paramedics within two hours of stroke onset is now expanding to include patients who cannot give their immediate consent.

"Deferred consent" in research studies is used in certain medical situations such as cardiac arrest or severe stroke that occur suddenly and render the victim incapable of providing informed consent for participation. Federal regulations enacted in 1996 allow deferred consent for research in select emergency circumstances in which the therapy may directly benefit the participant.

For this research trial, the Field Administration of Stroke Therapy-Magnesium (FAST-MAG) study, patients will only be enrolled using the deferred consent process if they are accompanied by family, friends, co-workers or other individuals who know them. The research doctor will explain the study to these individuals and give them an opportunity to decline the patient's participation. All patients will be notified about the study as soon as possible after they regain full competency.

In 2003, the National Institutes of Health awarded a $16 million grant to a consortium of Los Angeles County hospitals and emergency medical services provider agencies to perform the pivotal trial, which is being conducted at up to 69 county hospitals over the next four years. To date, the trial has enrolled more than 250 of the planned 1,298 patients, who are randomized to receive magnesium sulfate or a placebo.

In experimental models, magnesium sulfate reduces stroke damage by dilating brain blood vessels and by preventing buildup of damaging calcium in injured nerve cells.

"Time is of the essence in treating acute stroke," said Dr. Jeffrey Saver, professor of neurology at the David Geffen School of Medicine at UCLA and the study's principal investigator. "By incorporating paramedics to deliv
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Contact: Amy Albin
aalbin@mednet.ucla.edu
310-794-8672
University of California - Los Angeles
Source:Eurekalert

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