Stroke study to add patients who cannot give immediate consent

November 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 deliver a brain-protecting agent for the first time ever in a large trial, we hope to pioneer a new, more successful era in stroke therapy."

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.

All aspects of the proposed investigation, including the consent process and public notification prior to beginning the research, must be approved by the more than 40 emergency medical service and hospital institutional review boards overseeing the study.

Any community member who does not want to be included in this study without their own informed consent can obtain a medical alert bracelet that indicates to paramedics that he or she has chosen to opt out of the study. To obtain a bracelet, call the FAST-MAG Clinical Coordinating Center at (310) 794-6160.

The investigators welcome comments regarding the study from the public. They may be submitted to fastmag@ucla.edu.
-end-


University of California - Los Angeles

Related Stroke Articles from Brightsurf:

Stroke alarm clock may streamline and accelerate time-sensitive acute stroke care
An interactive, digital alarm clock may speed emergency stroke care, starting at hospital arrival and through each step of the time-sensitive treatment process.

Stroke patients with COVID-19 have increased inflammation, stroke severity and death
Stroke patients who also have COVID-19 showed increased systemic inflammation, a more serious stroke severity and a much higher rate of death, compared to stroke patients who did not have COVID-19, according a retrospective, observational, cross-sectional study of 60 ischemic stroke patients admitted to UAB Hospital between late March and early May 2020.

'Time is vision' after a stroke
University of Rochester researchers studied stroke patients who experienced vision loss and found that the patients retained some visual abilities immediately after the stroke but these abilities diminished gradually and eventually disappeared permanently after approximately six months.

More stroke awareness, better eating habits may help reduce stroke risk for young adult African-Americans
Young African-Americans are experiencing higher rates of stroke because of health conditions such as high blood pressure, diabetes and obesity, yet their perception of their stroke risk is low.

How to help patients recover after a stroke
The existing approach to brain stimulation for rehabilitation after a stroke does not take into account the diversity of lesions and the individual characteristics of patients' brains.

Kids with headache after stroke might be at risk for another stroke
A new study has found a high incidence of headaches in pediatric stroke survivors and identified a possible association between post-stroke headache and stroke recurrence.

High stroke impact in low- and middle-income countries examined at 11th World Stroke Congress
Less wealthy countries struggle to meet greater need with far fewer resources.

Marijuana use might lead to higher risk of stroke, World Stroke Congress to be told
A five-year study of hospital statistics from the United States shows that the incidence of stroke has risen steadily among marijuana users even though the overall rate of stroke remained constant over the same period.

We need to talk about sexuality after stroke
Stroke survivors and their partners are not adequately supported to deal with changes to their relationships, self-identity, gender roles and intimacy following stroke, according to new research from the University of Sydney.

Standardized stroke protocol can ensure ELVO stroke patients are treated within 60 minutes
A new study shows that developing a standardized stroke protocol of having neurointerventional teams meet suspected emergent large vessel occlusion (ELVO) stroke patients upon their arrival at the hospital achieves a median door-to-recanalization time of less than 60 minutes.

Read More: Stroke News and Stroke Current Events
Brightsurf.com is a participant in the Amazon Services LLC Associates Program, an affiliate advertising program designed to provide a means for sites to earn advertising fees by advertising and linking to Amazon.com.