ESETT Intermediate Public Announcement
Public Notification of a Seizure Research Study in Milwaukee County
Researchers at the Children’s Hospital of Wisconsin, Froedtert Hospital, and the Medical College of Wisconsin are studying the best way to treat long seizures.
This study will begin in January 2016. This study will compare three commonly used medicines given in the emergency department for long seizures. A person whose seizure does not stop even after receiving a full dose of medicine that can stop seizures (benzodiazepines) has a long seizure. This means that doctors need to use other medicines besides benzodiazepines. Researchers do not know which of the medicines will work the best. The three common medicines are fosphenytoin, valproic acid, and levetiracetam. The study plans to learn which of the three medicines works the best to stop a seizure quickly.
Normally, researchers get permission before a person can be included in a research study. A long seizure is an emergency and the doctors have to act quickly to treat a person. This means that there is little time to get permission. A person having a seizure is unconscious and cannot agree to join. In studies like this, a person’s consent before treatment is not possible. This is called an exception from informed consent for emergency circumstances. Researchers will discuss the study with the patient or family as soon as possible. This study meets the U.S. Food and Drug Administration guidelines for exception from informed consent under emergency circumstances.
Opting out of this study: Any adult who does not wish to be enrolled in this study may opt-out by wearing an opt-out bracelet or necklace. These may be requested free of charge by calling (414) 805-6493 or emailing ESETT@mcw.edu. Any parent/guardian of a child 17 years and younger that does not wish their child to be enrolled in this study may call (414)- 805-6493 or email ESETT@mcw.edu to discuss the opt-out options.
For information about the study or to request to not be included, please call Dr. Tom Aufderheide or Dr. Danny Thomas at (414) 805-6493, email at ESETT@mcw.edu, or visit the website at www.mcw.edu/ESETT.
