National RAMPART enrollment completed on January 14, 2011
Henry Ford Health System and Wayne State University/Detroit Medical Center participated in an unusual study intending to reduce brain damage or death of patients experiencing prolonged seizures before arriving at the hospital.
The RAMPART study involved patients with seizures lasting longer than five minutes that were being transported by EMS. Stopping the seizure as soon as possible is important to prevent brain-damage or death. Often the underlying cause of the seizure is unknown, but some causes include previous trauma, stroke, tumor, or infection.
The study, called RAMPART, compared an intramuscular injection of midazolam (Versed) to an intravenous (IV) dose of lorazepam (Ativan). Both drugs are better than the current prehospital treatment for seizure, IV diazepam (Valium). The goal is to determine if an auto-injector with midazolam can stop seizures as fast as starting an IV and giving lorazepam.
The possible benefits include shorter seizures, more rapid drug administration, development of an auto-injector that could be used by non-medical personnel, and avoidance of multiple IV attempts on a seizing patient.
Because the patients were unconscious during the seizure, they were not able to provide informed consent to participate in the study.
The Food and Drug Administration created regulations for research to be performed during emergency conditions without informed consent of the patient. Once patients awaken from the seizure their consent was sought so that they could continue in the study.
As a requirement to conduct emergency research without informed consent members of the RAMPART study teams worked together to inform to community about the study before any patients were enrolled.
The RAMPART study was conducted by 17 centers and 40 EMS agencies around the United States. It was coordinated by the University of Michigan and funded by the National Institute of Neurological Diseases and Stroke which is a part of the National Institute of Health.
In the state of Michigan the study was conducted in conjunction with Detroit EMS and West Bloomfield EMS. Any patients that were actively seizing upon arrival were eligible to participate in the study. In Detroit to be enrolled in the study the patients had to meet the inclusion and exclusion criteria and be transported to Henry Ford Hospital, Detroit Receiving Hospital, Sinai-Grace Hospital, or St. John’s Hospital. In West Bloomfield to be enrolled in the study the patients had to meet inclusion and exclusion criteria and be transported to Henry Ford West Bloomfield Hospital.
The RAMPART study began in Detroit on August 27, 2009 and in West Bloomfield on April 19, 2010. The end of the RAMPART study occurred on January 14, 2011. The Institutional Review Boards (IRB) for Henry Ford Health System and Wayne State University periodically reviewed and monitored the safety of the RAMPART study before, during, and after enrollment. Later this year, after the data is analyzed, results will be published in a scientific journal and Henry Ford Health System and Wayne State University/Detroit Medical Center will inform the local community of the results.
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