Prolonged seizures, lasting more than several minutes, are a medical emergency requiring immediate treatment to prevent significant disability or death. University of Maryland School of Medicine researchers are taking part in a nationwide study to determine which of two drugs currently used in the hospital, when given prior to hospital arrival, produces the best outcomes for people experiencing these prolonged seizures, also known as status epilepticus. The study is called the Rapid Anticonvulsant Medications Prior to Arrival Trial (RAMPART).
If prolonged seizures are not treated immediately, they can lead to brain injury and death in as many as 25 percent of cases. With the RAMPART study, we hope to find a definitive answer on which drug and delivery method offers the best chance for safe, successful treatment,” explains Barney Stern, M.D., a neurologist at the University of Maryland Medical Center and a professor of neurology at the University of Maryland School of Medicine.
Because status epilepticus is a medical emergency, treatment typically begins before the patient arrives at the hospital, either at the scene or in an ambulance. The sooner someone having a seizure gets treatment, the better the outcome. For this study, ambulances will be equipped with RAMPART kits containing either lorazepam, delivered as an injection in the vein (IV), or midazolam, delivered as an injection into the muscle (IM).
“Emergency personnel may have a challenging time getting an IV in a patient who is having convulsions; however, right now, we do not know if the intramuscular drug delivered in the field is as effective as the IV medication. We hope the research results will help to establish a national standard for treatment and ensure that future patients receive the best treatment possible,” says Tricia Ting, M.D, a neurologist and epilepsy specialist at the University of Maryland Medical Center. Dr. Ting is also an assistant professor of neurology at the University of Maryland School of Medicine.
E. Albert Reece, M.D., Ph.D., M.B.A, vice president for medical affairs, University of Maryland, and dean, University of Maryland School of Medicine says, “The results from the RAMPART study may have a significant impact on how emergency personnel treat patients with status epilepticus in the future. Determining the most effective delivery method will mean that the seizures may be stopped sooner, which, we hope, will translate into fewer deaths and less disability.”
A transmitter in the RAMPART kit sends a signal alerting the researchers when a kit is opened. Emergency personnel will give all patients both the IV and intramuscular injection: one will contain the actual medicine, the other will be a placebo. They will record when they start treatment and when the seizure stops. The researchers, who will not know which drug the patient received, will follow-up with patients to check their conditions and look for any side effects of the medications, which may include slowed breathing and excessive sleepiness. Once the study is completed, they will analyze the data to see if either drug proved to be safer or more effective, or if both produced similar results.
The researchers will first train Baltimore City emergency personnel and will then expand the study to include other jurisdictions in Maryland. The University of Maryland is one of 17 centers across the country participating in the National Institutes of Health-sponsored trial, which will enroll 900 patients over three years. To be enrolled, adult patients must still be seizing when emergency personnel arrive and must have been seizing for more than five minutes.
Patients having status epilepticus are unconscious and unable to give informed consent to enroll in the study. Normally, researchers must ask the patient or the patient’s relative or guardian for permission to enroll him or her in a study and explain the details and procedures of the study, including its potential risks and benefits. However, this is not possible since these patients will be having a seizure and need immediate medical intervention to limit potential neurological damage. So, following strict federal guidelines, patients meeting the RAMPART criteria will be enrolled in the study and informed after they have regained consciousness or when family members or legally authorized representative can be told.
“We have designed a public information campaign, which includes community meetings and advertising, to alert the citizens of Maryland about this new research. We want people to know that the University of Maryland is participating in this national seizure study and how they may be affected,” says Dr. Stern.
The RAMPART study has been reviewed by the Institutional Review Board at the University of Maryland School of Medicine to ensure that it complies with all ethical and safety standards. The program also meets federal regulations for a waiver of informed consent.
Most seizures are brief and stop by themselves; however, according to the researchers, there are an estimated 120,000 and 200,000 cases of status epilepticus in the United States each year, resulting in as many as 55,000 deaths. Other complications may include breathing trouble, abnormal heart rhythm, altered level of consciousness and injury to the brain or nervous system.
For more information or to learn how to opt out of study, call 1-800-492-5538
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