OHSU Study to Determine Which Seizure Medication, Delivery Method is Best
06/15/09 Portland, Ore.
Study will test treatments in people having seizures outside of the hospital
Most seizures are short and stop by themselves, but prolonged seizures, also called status epilepticus, are life-threatening medical emergencies that can result in injury or death. Oregon Health & Science University is beginning a study to determine the best method for delivering medication to people suffering from prolonged seizures outside of a hospital.
The study, called the Rapid Anticonvulsant Medication Prior to Arrival Trial, or RAMPART, will test two anti-seizure medications commonly administered by paramedics – lorazepam (Ativan), and midazolam (Versed). Lorazepam is generally administered intravenously through a small tube in the vein that can be difficult to insert in a person having a seizure. Midazolam is generally administered through a shot directly into muscle. Giving the medication as a shot may be faster, but may not stop the seizure as quickly.
The RAMPART study will test a device similar to an EpiPen, which is commonly used by people with severe allergies. Study participants will randomly receive either midazolam injected with an EpiPen, or lorazapam administered through an IV. Both of these medications have similar effects in stopping seizures, but no head-to-head comparisons have been done to see whether one is more effective than the other.
"If we find delivery of anti-seizure medication through an Epi-Pen is effective, it could give families of people suffering from seizure disorders hope for quickly helping their loved ones," said OHSU principal investigator Craig Warden, M.D., associate professor of emergency medicine in the OHSU School of Medicine.
OHSU will be conducting this study in conjunction with Clackamas Fire District #1. Only patients who experience prolonged seizures in Clackamas County will be eligible for this study.
Because individuals having prolonged seizures may be unconscious or unable to consent to being part of a study, RAMPART will be conducted under specific Food and Drug Administration (FDA) guidelines that allow investigational treatment in certain life-threatening emergency situations without getting prior consent. The federal regulations that allow this waiver of consent require representatives from the community be consulted and informed of the risks and benefits of the study.
OHSU has held a series of focus groups and meetings with community members, and made outreach to medical clinics and organizations for people who suffer from seizure disorders. This study has been reviewed by the OHSU Institutional Review Board, and a Data Safety Monitoring Board comprising researchers and physicians not involved in the study will regularly review the data to ensure the safety of those involved.
Individuals enrolled in this study will be transported to Kaiser Sunnyside Medical Center, OHSU, Portland Adventist Hospital, Providence Milwaukie Hospital, Providence Portland Medical Center or Willamette Falls Hospital.
OHSU is one of 17 sites nationally that will be participating in RAMPART. The study is part of the Neurological Emergencies Treatment Trials (NETT) and funded in part by the National Institutes of Health. By involving many sites in both rural and metropolitan areas, the NETT is able to enroll large numbers of patients and more efficiently and quickly put results into practice for the entire American population.
Anyone who wishes not to be part of this study can request a bracelet similar to a medical alert bracelet with "No Study" printed on it. This will exclude an individual from this and all other current and future exception from informed consent studies. Bracelets can be requested by calling the study coordinator at 503 494-9771. More information about the RAMPART study can be found online: www.ohsu.edu/emergency/rampart
Oregon Health & Science University is the state's only health and research university, and Oregon's only academic health center. OHSU is Portland's largest employer and the fourth largest in Oregon (excluding government). OHSU's size contributes to its ability to provide many services and community support activities not found anywhere else in the state. It serves patients from every corner of the state, and is a conduit for learning for more than 3,400 students and trainees. OHSU is the source of more than 200 community outreach programs that bring health and education services to every county in the state.