Your cart is empty✖
Your cart is empty
This entry was posted on January 26, 2009.
Starting next month, if you have a seizure requiring emergency treatment, you could be enrolled in a research trial without your permission.
While subjects in most medical studies must sign lengthy forms to participate, unconscious, convulsing patients can't give consent. So paramedics will enroll seizure victims in the new study automatically, unless they're wearing a red "opt-out" bracelet.
The unusual approach has been carefully reviewed by medical and ethics experts, and researchers say most people at high-risk for seizures have been supportive.
Stanford and the University of California-San Francisco are two of 17 research centers nationwide that will be studying the best way to give anti-seizure medications. Patients being transported to hospitals in Santa Clara, San Mateo and San Francisco counties will be subject to the new study.
It's the only way to learn about life-saving treatments in an emergency, said Dr. James Quinn, associate professor of emergency medicine at Stanford and a lead researcher on the Rapid Anticonvulsant Medication Prior to Arrival Trial (RAMPART).
"Everybody should be able to give their own individual consent to participate in research," Quinn said. "Unfortunately, in emergency situations some people can't give consent."
Most seizures stop on their own before paramedics arrive. But seizures that last more than a few minutes can damage muscle, heart and brain cells â€” and even lead to death. Stopping seizures as quickly as possible is critical, but no one has tested the best way to give anti-seizure medications in an emergency.Currently, if a patient is having a seizure â€” due to epilepsy, head trauma or other reasons â€” paramedics may give one of several different anti-seizure medications. Depending on regional protocol, the drugs may be delivered through a vein, into the muscle or even via a rectal suppository.
For the study, researchers will compare two methods of giving anti-seizure medications: the traditional way, by placing an intravenous line (IV), and a newer way that uses a pre-loaded syringe to administer a shot in the muscle.
Patients in areas covered by the study will get both an IV and an intramuscular shot, but only one of those will contain an anti-seizure drug â€” either a drug called lorazepam in the IV, or a drug called midazolam in the shot.
"The study is lower risk," Quinn said, "in that nobody is getting a placebo; everybody is being treated."
Before approval, the trial went through a rigorous review process by the National Institutes of Health and the universities' ethics boards.
Studies like this must meet strict guidelines, said Dr. Arthur Caplan, director of the Center for Bioethics at the University of Pennsylvania. Similar trials have been done to test heart attack treatments and new blood products.
"You have to be able to show that you can't really study what you're trying to study in any other way," Caplan said.
Researchers must also prove the trial offers a direct benefit to patients and that they've taken steps to publicize the study.
For the past 10 months, RAMPART researchers have been conducting focus groups, running ads in local papers and speaking at community gatherings. The researchers focused their outreach on high-risk groups, including people with epilepsy and those recovering from drug or alcohol withdrawal and stroke.
Despite the potential for controversy, Quinn said, most people have responded positively.
"About 87 percent of people agreed or strongly agreed that the benefits were worth the risks," Quinn said, "and they would agree to participate if it was worthwhile to the community."
So far, only a handful of people have asked for the opt-out bracelet, said Michele Meeker, clinical research coordinator at UCSF. Similar to the popular "Live Strong" bands, the red-and-white rubber bracelets read "RAMPART Declined."
Some hope the study results will eventually lead to a device people could carry to stop emergency seizures â€” a shot pre-loaded with anti-seizure medication, similar to an Epi-pen for severe allergic reactions.
"If they can do that, what a relief," said Paula Apodaca, who has lived with epilepsy for more than 50 years and said she'd be happy to participate in the study.
To read the rest of the article click here.