Autoinjector is Effective Method for Treating Prolonged Seizures
March 15, 2012
Henry Ford Health System and Wayne State University were among 17 major research centers involved in the study called Rapid Anticonvulsant Medication Prior to Arrival Trial (RAMPART). This is the first randomized clinical trial to compare intramuscular (IM) treatment via an auto-injector, like an Epi-Pen, to intravenous (IV) treatment for stopping prolonged seizures known as status epilepticus. Seizures that last longer than five minutes can cause brain damage or death. An estimated 55,000 people die every year from status epilepticus.
Launched in 2009, RAMPART enrolled 893 patients nationwide including children and adults. More than 4,000 paramedics and 33 emergency medical services agencies were involved in administering the drug therapies in the field. They used study boxes with a time-stamped voice recorder that recorded the time treatment began and the time the patient's convulsions stopped, without having to interrupt patient care and record data. Paramedics sought to control seizures within 10 minutes without having to give a second dose of medication.
The three-year study tested whether paramedic administration in the field of IM midazolam (Versed®) by an auto-injector was more effective at stopping seizures prior to hospital arrival than giving IV lorazepam (Ativan®).
The study found that seizure patients recovered faster from a status epilepticus when their medication was injected IM rather than administered IV. Both medications are part of a class of anticonvulsant drugs considered the most effective for controlling seizures, benzodiazepines.
The study found that:
- 73 percent of patients who received midazolam by auto-injector were seizure-free when they arrived at the Emergency Department.
- 63 percent of patients who received lorazepam intravenously were seizure-free when they arrived at the Emergency Department.
- Patients who received midazolam were less likely to be hospitalized than patients treated with lorazepam.
- Patients in both groups who were hospitalized had low rates of recurrent seizures.
- More research is required to determine whether auto-injectors might someday be available for use by epilepsy patients and their family members.
Because patients are unconscious during a seizure, they cannot give consent. These patients were enrolled under a federal guideline for emergency research that provides for an exemption from informed consent. The study required approval from local hospital human subject protection boards and the involved medical control authorities. Consent to continue to participate in the study was sought as soon as family members were available or the patients awakened.
The National Institutes of Health-sponsored study which was published in The New England Journal of Medicine February 16th, 2012.
Taher Vohra, M.D., from Henry Ford Emergency Department and Robert Welch, M.D. from Detroit Receiving Emergency Department led the local efforts for this study. Detroit Emergency Medical Services and West Bloomfield Fire were the local EMS participants. Detroit EMS was the largest recruiter in the country, making this trial clearly applicable to our patient population.
This study provides paramedics with another option when treating seizure patients experiencing life and brain threatening prolonged seizures.
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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