BETHESDA, Md. — NIH research investigated the benefits of early administration of magnesium sulfate to stroke patients. The study found that paramedics may be able to start therapy as soon as stroke is suspected and before arriving at the hospital.[1]
Researchers developed a novel approach for a stroke clinical trial and wanted to know if it was possible to shorten the time between stroke onset and treatment by having paramedics administer stroke therapies as soon as stroke is suspected. Most stroke patients tend to receive initial treatment after in hospital testing, which may be hours after the stroke began.
FAST-MAG trial
The Field Administration of Stroke Therapy-Magnesium (FAST-MAG) Phase 3 Trial was a multi-center, randomized, placebo-controlled clinical study. 1700 patients who were suspected of having had a stroke were given magnesium sulfate or a placebo by paramedics within two hours of stroke onset.
Paramedics used a version of the Los Angeles Prehospital Stroke Screen developed by the Investigators to rapidly and accurately identify potential stroke patients. Paramedics then contacted a neurologist via cellphone to further determine if a patient should be included in the study. After this contact, the patients or their representatives provided permission to the study doctor to participate in the trial.
74.3 percent of patients received a study intervention within 60 minutes of stroke onset; faster than in other stroke trials. “The most important finding of this study was that medication could be delivered within the ‘golden hour’ of first onset of stroke symptoms when there is the greatest amount of brain to save,” said Jeffrey Saver, M.D., director of the University of California, Los Angeles Comprehensive Stroke Center.
Test of magnesium sulfate’s neuroprotective effects
In addition to testing the new protocol, the researchers wanted to see if magnesium sulfate improved outcomes in patients 90 days after stroke. Magnesium sulfate has been shown to exhibit neuroprotective effects in animal models of stroke.
“Unfortunately the drug we tested turned out to be ineffective,” said Saver.
Magnesium sulfate was not better than placebo at reducing disability following stroke.
“There are several trials underway that are taking elements of the FAST-MAG platform and applying it to test promising agents for neuroprotection,” said Saver.
“We believe this study represents a paradigm shift in the treatment of stroke and potentially numerous other neurological conditions,” said co-principal investigator Dr. Sidney Starkman. “We’ve never done something this large that demonstrates that paramedics not only are eager to provide the best possible patient care, but also are capable of being invaluable partners in an intense, time-dependent clinical trial.”
The study, published in the New England Journal of Medicine and funded by the National Institute of Neurological Disorders and Stroke (NINDS), “shows that it is possible to get treatments to stroke patients even before they arrive at a hospital,” said Walter Koroshetz, M.D., acting director of NINDS.
“This pre-hospital approach to treatment is sure to be adopted and refined in future clinical research studies,” said Koroshetz.
References
[1] Saver et al. “Prehospital Magnesium Sulfate as Neuroprotection for Acute Stroke,” New England Journal of Medicine, February 5, 2015.