RAMPART Seizure Trial Published in New England Journal of Medicine

Austin-Based HPCR, Austin-Travis County EMS Managed Study in Collaboration with Seton, St. David’s

AUSTIN, TX — A national study of pre-hospital seizure treatments, managed locally by Hospital Physicians in Clinical Research, PLLC (HPCR), will be published in the Feb. 16 issue of the prestigious New England Journal of Medicine, marking a milestone for biomedical research in Central Texas.

The Rapid Anticonvulsant Medication Prior to Arrival Trial (RAMPART) studied two benzodiazepine treatments for prolonged, active seizures (status epilepticus) in the pre-hospital ambulance setting. Subjects were randomized during treatment in the field by Austin-Travis County EMS paramedics and transported to either Seton or St. David’s emergency departments.

Austin-based HPCR managed the trial as one of the sites in the Neurological Emergencies Treatment Trials (NETT) network. HPCR was responsible for data collection, regulatory compliance, training and education, logistics and ethical oversight for the Austin spoke of the trial, which enrolled about 10 percent of the 893 patients participating in the study.

HPCR is a wholly-owned subsidiary of Emergency Service Partners, L.P., whose physicians directed the Austin portion of the trial. Dr. T.J. Milling, Director of Medical Research for HPCR, is a leading member of the study group that published the manuscript.

The research concluded that delivering the anti-seizure medication midazolam by an autoinjector is faster and may be a more effective way to stop prolonged seizures than using lorazepam, the current standard of care, which must be administered intravenously. Patients treated with midazolam were more likely to be seizure-free upon arrival at the hospital and were less likely to require hospitalization than those receiving IV lorazepam.

“This was an important study that will greatly improve care for patients with seizures,” Milling said. “But more importantly, it really showcased what Austin is capable of in biomedical research.”

HPCR was founded in 2009 in part to allow Emergency Service Partners’ more than 300 Texas physicians the opportunity to participate in academic research. The organization is also expected to play a major role in a future emergency medicine residency program in Austin.

Austin state Sen. Kirk Watson and other area leaders have recently expressed increased interest in developing a medical school and a new teaching hospital in Austin. Research conducted by HPCR, coupled with the recent growth of biotechnology firms in the area, indicates that Central Texas is poised to become a major player in the health care industry.

“Austin clearly is hungry for biomedical research and all that it means in terms of better care, prestige, economic stimulus and job growth,” Milling said.

The study was the first in Austin to be conducted under exception from informed consent for emergency research, a federal regulation to protect patients who are involved in research when consent is not possible. Since patients experiencing seizures fall into this category, community consultations and public disclosures were arranged in advance to raise awareness, ensure transparency, and obtain input from local residents.

“The support we received from our world-class EMS system, the Austin City Council, the Travis County Commissioners Court, and many other corners was amazing,” Milling said. “Clinical research and academic medicine really is Austin’s next big thing.”

Ben King, HPCR Project Manager, agreed that community support was an exciting and vital part of the project.

“For HPCR being such a young company, building positive ties with the community in such a wide range of areas was an incredible experience, underscored by the willingness of the Seton and St. David’s network partners to work together with us on this important study,” King said.

Austin-Travis County EMS Medical Director Dr. Paul Hinchey said his organization was pleased to collaborate with local hospitals on the study.

“Our active participation in this study allowed our EMS providers to contribute to the body of science associated with pre-hospital medicine,” Hinchey said. “Most importantly, this type of clinical research allows us to use an evidence-based approach to define effective treatments for patients with potentially life-threatening conditions.”

Community members are invited to call (512) 610-0370 with feedback or questions, positive or negative, about the study and the exception from informed consent.

The RAMPART trial was sponsored by the National Institute of Neurological Disorders and Stroke (NINDS), part of the National Institutes of Health.

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About Hospital Physicians in Clinical Research

Hospital Physicians in Clinical Research is the research arm of a large multi-specialty physician group with a focus on emergency and critical care. Staffed with experienced physician investigators, coordinators and technicians, HPCR is poised to manage and participate in virtually any investigator-initiated, grant-funded, and industry-funded study in the emergency department, ICU or clinic setting. HPCR provides a single contact point to access more than 300 potential principal investigators boarded in multiple specialties throughout Texas. HPCR works closely with the Seton Healthcare Family (based in Austin, TX) and the St. Joseph Health System (based in Bryan, TX). For more information, please visit http://www.researchhpcr.com.

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