DETROIT – Henry Ford Hospital is part of a national research study that will compare the effectiveness of three anti-seizure medications for treating a type of epileptic seizure in the Emergency Department without first obtaining patients’ informed consent.
The seizure, known as status epilepticus, or SE, is a life-threatening convulsion that lasts longer than five minutes without stopping or doesn’t respond to adequate doses of medication to make it stop. It affects individuals young and old, and can cause brain damage, and affect one’s ability to think and remember things.
During emergency conditions federal regulations allow research to be performed without the informed consent of patients who are unconscious or unable to give consent. As soon as a family member is available or the patient wakes up from the seizure, they will be told about the study and asked to give permission to continue their participation.
The study, called Established Status Epilepticus Treatment Trial (ESETT), aims to determine which of three commonly used medications – fosphenytoin, levetiracetam and valproic acid – is safer and faster at quickly stopping SE in patients that don’t respond to initial standard medications such as valium.
“The medications being evaluated work in different ways and have different risks,” says Christopher Lewandowski, M.D., a Henry Ford Emergency Medicine physician and principal investigator. “We’re hopeful the information we collect from this study will help decide for us which one works best for quickly stopping this type of seizure before it can cause irreparable harm to patients.”
Henry Ford is one of 50 hospitals nationally and one of four in the city of Detroit participating in the five-year study. Researchers seek to enroll a total of 795 patients ages 2 and older. Other Detroit participating hospitals are Children’s Hospital of Michigan, Detroit Receiving Hospital and Sinai-Grace Hospital.
This is a double-blind study, meaning patients who are brought to the Emergency Department having an ongoing seizure will randomly receive one of the study medications.
For years, Emergency Departments have used the study medications “off-label” to stop prolonged seizures in adults and children. Levetiracetam and valproic acid are not approved by the U.S. Food and Drug Administration for treating ES. Fosphenytoin is FDA approved for treating SE in adults but not children. Results of the study could change the labeling regulations for the medications.
The study is funded by the National Institute of Neurological Disorders and Stroke, a branch of the National Institutes of Health, and is organized as part of the National Emergencies Treatment Trials Network.