Emergency medicine researchers at UC will soon begin a clinical trial to determine whether it is as effective to use an auto injector to deliver anti-seizure medications to patients intramuscularly (IM) as it is to treat seizing patients by intravenous injection (IV), the current EMS protocol.
The UC research team was selected along with 16 other prominent research institutions across the nation to conduct the emergency medicine trial known as RAMPART (Rapid Anticonvulsant Medication Prior to Arrival Trial) within the Neurological Emergencies Treatment Trials (NETT) Network.
The network, formed by the National Institutes of Health, conducts large simple trials to reduce the burden of very acute injuries and illnesses affecting the brain, spinal cord and peripheral nervous system.
"We believe we have a better method, which is an auto injector, to give medication as fast or faster than a paramedic can get an IV started," says Arthur Pancioli, MD, vice chairman and distinguished professor of clinical research in the department of emergency medicine at UC.
An auto injector is a device such as an EpiPen designed to deliver a single dose of a particular drug, commonly via a spring-loaded syringe.
"Prolonged seizures are dangerous, and may be life threatening. Itís estimated that as many as 200,000 episodes of prolonged seizures requiring medical intervention occur each year, resulting in as many as 55,000 deaths," says Pancioli, who also serves on a national level as director of NETT operations.
What makes this trial unique from most others is the FDA federal regulation called "exception from informed consent." Such regulations are strict and the research must meet very specific federal regulations and local Institutional Review Board review and approval. They give the researcher the ability to enroll patients into the study when they cannot speak for themselves because of life-threatening injury or illness.
Exception from informed consent requires that the community receive education about the study. The reason emergency research like this is allowed, Pancioli and study coordinator Irene Ewing explain, is because patients may be unable to provide consent, or the time it takes to explain the study could delay life-saving treatment.
"You are not going to be able to consent if you are seizing," says Ewing, also a registered nurse, who adds that persons wishing not to be included can request an opt-out bracelet that indicates to paramedics the patient declines to be part of this study.
According to Pancioli, people with a history of prolonged seizures will make up the majority of study subjects, although someone with no history of seizures, experiencing a first-time seizure, could become part of the study as well.
"If you are a patient with prolonged seizures the paramedics will treat you with the same type of medications that we are using in the study," says Pancioli. "The principal issue in the trial is the method of delivering that medication. If we can demonstrate that the auto injector method is as effective as starting an IV and delivering medication by that method, then we will be able to offer a wonderful new method to routinely treat prolonged seizures."
The team is holding community meetings in local libraries to discuss the study.
For more information, or to request an opt-out bracelet, call (513) 558-0095 or (866) 929-6368, or visit the NETT Web site at nett.umich.edu.