April 30, 2013
The study, sponsored by the National Institute of Neurologic Disorders and Stroke, was conducted with partners throughout the nation including the Glendale Fire Department in partnership with the University of Arizona’s Emergency Medicine Research Center (AEMRC).
The Society for Clinical Trials has awarded the 2012 Trial of the Year to the Rapid Anticonvulsant Medication Prior to Arrival Trial, known as RAMPART, which has led to better pre-hospital treatment for people suffering prolonged seizures.
The study, sponsored by the National Institute of Neurologic Disorders and Stroke, was conducted with partners throughout the nation including the Glendale Fire Department in partnership with the University of Arizona’s Emergency Medicine Research Center (AEMRC).Prolonged seizures kill 55,000 Americans each year and thanks to the RAMPART Trial, a quicker and more practical way of treating life-threatening seizures before patients reach the hospital has been confirmed.
The results of the study were published in the February 2012 issue of The New England Journal of Medicine where findings revealed that, for patients in prolonged seizure, the intramuscular injection of the seizure medication midazolam was found to be at least as safe and effective as the medication lorazepam administered intravenously for pre-hospital seizure cessation.
In all, RAMPART involved more than 4,000 paramedics, 33 emergency medical services (EMS) agencies and 79 hospitals across the United States to test the efficacy of intramuscular auto-injectors filled with the medication midazolam versus the use of the intravenous medication lorazepam for the treatment of acute seizures.
Ultimately, more than 1,000 patients with convulsive seizures lasting longer than five minutes were randomly assigned to either intravenous lorazepam or intramuscular midazolam.
The RAMPART study was designed and conducted by the Neurological Emergencies Treatment Trials (NETT) Network. The NETT is a multidisciplinary clinical trials network of regional hubs dedicated to improving the care of neurological emergencies and is funded by the National Institute of Neurological Disorders and Stroke.The Glendale Fire Department and the UA’s AEMRC have been recognized for their key role in this groundbreaking study. The Glendale Fire Department was recognized as the trial’s top performer out of 33 EMS agencies in the nation for its National Institutes of Health quality measurements in the collection and reporting of data for the study.
“The RAMPART study principles resonated completely with the Glendale Fire Department Motto: Fast, Caring, Innovative, Professional. Clearly, the RAMPART trial design, with its lack of placebo arm (every enrolled patient got therapeutic and potentially lifesaving medication) and easily measured end-points was the very definition of innovative,” said Garth Gemar, MD, medical director of the Glendale Fire Department. A total of 58 patients were enrolled in Glendale during the trial.
Kurt Denninghoff, MD, distinguished professor and associate head for research at the UA Department of Emergency Medicine, is principal investigator for the National Institutes of Health funded Southwest Neurological Emergencies Treatment Trials Network (SwNETT) Regional Hub. This regional network includes multiple collaborators from Arizona and New Mexico, working on several trials like RAMPART with Dr. Denninghoff coordinating various NETT research activities, including the RAMPART study, with several EMS and many hospitals within the Southwest region. His work to foster regional collaborative effort has resulted in more than $3.2 million in clinical research support for the Southwest.“This is a groundbreaking study that will improve patient outcomes from this life-threatening emergency in the pre-hospital environment throughout the world,” said Daniel Spaite, MD, FACEP, professor and Distinguished Chair of Emergency Medicine and director of EMS Research at the UA Department of Emergency Medicine. Spaite was the site principal investigator for the $500,000 SwNETT RAMPART study. He oversaw the protocol compliance for the study and maintains key collaborations with all hospitals receiving study patients and with EMS providers, including recruiting and training the Glendale Fire Department specifically for the SwNETT RAMPART study.
Bruce Barnhart, RN, CEP, UA Department of Emergency Medicine Research coordinator, served as the senior research coordinator for the study and Ben Bobrow, MD, FACEP, professor of emergency medicine at the University of Arizona College of Medicine – Phoenix, served as the study’s site co-investigator.
“The RAMPART trial was the first of its kind in our region and initiating the trial required selfless effort by a large number of people. Glendale Fire chief Mark Burdick, Dr. Bobrow and Dr. Spaite were key to us being able deploy the trial so successfully with the Glendale Fire Department. However; I must add, that Bruce Barnhart and Willie Haro who served as our EMS educators and study coordinators were simply amazing as well. It has been an honor to work with them on such an important project,” said Dr. Denninghoff.
Glendale Fire Department paramedics received initial training and continuing medical education in the management of seizures and other neurologic emergencies, as well as supplemental training in human subject’s research protections and in the study protocol.
“Our familiarity with Drs. Denninghoff, Spaite and Bobrow and their immense professional reputations allowed the Glendale Fire Department to trust that this was indeed a landmark trial with great potential benefit not just for the City of Glendale but for all those afflicted with seizure disorders, a greatly underserved population,” said Dr. Gemar.
Study Background
Many EMS systems have begun to use midazolam injected intramuscularly largely because intramuscular administration is faster and is consistently achievable when compared to medication administered intravenously. The practice has become increasingly common despite the lack of clinical-trial data regarding the efficacy and safety of intramuscular midazolam.
Intravenous lorazepam is the preferred treatment for patients with seizures in the emergency department, but it is rarely used by paramedics in the pre-hospital setting because of the potential difficulty with intravenous administration, as well as the short shelf-life of lorazepam, when it is not refrigerated.
The study looked to assess whether midazolam injected intramuscularly would provide EMS medical directors with a practical alternative that is at least as safe and effective as intravenous lorazepam.
The lead investigators from this award winning trial will address the Society at a plenary session during the Society for Clinical Trials 34th Annual Meeting to be held May 19-22, 2013.