RAMPART (Rapid Anticonvulsant Medication Prior to Arrival Trial) is an emergency medicine clinical trial designed to save and improve the lives of people who experience an ongoing acute seizure, also known as status epilepticus. In the past, pre-hospital treatment of patients with ongoing seizures was limited to supportive care and rapid transport to a hospital. More recently, pre-hospital treatment for patients who suffer from this type of seizure has been intravenous (IV) medication, or intramuscular (IM) medication. Right now it is uncertain which of these two standard treatment types is best at stopping seizures. The best possible outcome for patients in status epilepticus is likely to depend on a treatment that leads to a rapid termination of the seizure.
The RAMPART study plans to look at the value and speed of an IM injection of midazolam, using a new fast-release syringe, versus administering lorazepam by way of establishing an IV line. There is a 50/50 chance a patient in status epilepticus could be assigned one or the other treatment. All patients in the study however shall receive one of the standard treatments. Additional treatment per patient response and local ambulance protocol will be given until the patient is transported to a hospital emergency room.
Patients receiving either treatment will have to actively be seizing; therefore, research participants will not be able to give their permission, nor is there any time to collect an informed consent beforehand. Following arrival at the hospital, or as soon as possible, patients will be notified of their enrollment in the study. In cases where a patient remains unconscious, or under the age of 18 years, a patient representative will be notified about the patient's study enrollment. Regardless of which treatment a patient receives, all patients enrolled in the study receive the medical standard of care and management necessary for their injuries and symptoms. Opt-Out Bracelets will be available for those who do not wish to participate.
This study is being funded by the National Institute of Health through the Neurological Emergencies Treatment Trials Network (NETT), and is being conducted in 17 cities nationwide.
San Francisco Principal Investigator - Claude Hemphill, MD, Department of Neurology, San Francisco General Hospital
San Francisco Co-Investigator - Karl Sporer, MD, Medical Director, SFFD Emergency Medical Services Division
For more information about this study, or to obtain an Opt-Out Bracelet, please contact: Michele Meeker, RN, BSN at (415) 206-3220 or via e-mail at: firstname.lastname@example.org
You may also visit: www.sitemaker.umich.edu/ucsf/rampart
For information on protection of research subjects, please see the UCSF Committee on Human Research (CHR) at: www.research.ucsf.edu/CHR
This site provides a link to the FDA website as well.
You can also call the CHR at: (415) 476-1814.