Arthur Pancioli, MD, (left) instructs resident Brent Gottesman, MD, in University Hospital's emergency department. He will serve as the principal investigator for the Cincinnati hub of a new neurological network.
'RAMPART' Study Ending Enrollment: 133 Patients Enrolled Locally
CINCINNATI—The University of Cincinnati (UC) Department of Emergency Medicine has completed its participation in the clinical research study "Rapid Anticonvulsant Medications Prior to Arrival Trial” (RAMPART). The national trial reached its enrollment target Friday, Jan. 14, and has stopped enrolling patients across the country.
UC began enrollment in RAMPART June 2009, working with fire/EMS departments in Cincinnati, Blue Ash, Forest Park and Green Township in Ohio and Florence and Independence in Kentucky. RAMPART was designed to study if anti-seizure medications given as a shot in the muscle were just as effective as anti-seizure medications given by intravenous injection (IV), the current protocol.
UC was one of 17 research institutions to conduct the trial, which was carried out under the Food and Drug Administration (FDA) federal regulation "exception from informed consent.” Such regulations require trials to meet 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 their life-threatening injury or illness.
Residents in participating communities who opted out of the trial by wearing a "RAMPART Declined” bracelet can now stop wearing this bracelet.
"The UC Team would like to thank the communities and EMS agencies that participated in this important work," says UC RAMPART coordinator Irene Ewing, a registered nurse.
Locally, fire/EMS crews enrolled 133 patients, both adults and children.
Arthur Pancioli, MD, principal investigator for RAMPART and chair of the UC Department of Emergency Medicine, says the trial could help first responders better treat seizures.
"Prolonged seizures are dangerous, and may be life threatening," says Pancioli. "It's imperative that these patients receive medical intervention as quickly as possible. If RAMPART demonstrates 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.”
He says results from the study should be released to the local public this spring and will also be available on the RAMPART website after the data have been analyzed.
For more information, contact Ewing at (513) 558-0095.