Temple Taking Part in Nationwide Study Designed to Save & Improve the Lives of People Who Experience Life-Threatening Seizures
Temple University Hospital is taking part in an emergency medicine research study designed to try to save and improve the lives of people who experience a seizure lasting longer than five minutes, and which has failed to respond to a full dose of medicine (benzodiazepines like valium) to make it stop. These patients are considered to have Established Status Epilepticus (ESE).
Status Epilepticus (SE) is a life-threatening condition in which the brain is in a state of persistent seizure. SE is defined as a seizure or recurrent seizures lasting longer than five minutes without stopping on its own or without waking up. There are approximately 120,000-180,000 episodes of SE each year in the U.S. and about one third of SE patients continue to have a seizure that will not stop (ESE). Long-lasting seizures can affect a person’s memory and ability to think. They can prevent a person from returning to work or functioning independently, and can also cause permanent brain damage or even death.
The Established Status Epilepticus Treatment Trial, or ESETT, will look at three commonly used medicines given in the emergency department to treat ESE: phenoytoin (fPHT), valproic acid (VPA) and levetiracetam (LVT) to learn which treatment is most effective at stopping a seizure quickly.
"Emergency department care of ESE in the U.S. is not the same everywhere," said Nina T. Gentile, MD, Professor of Emergency Medicine at the Lewis Katz School of Medicine at Temple University, and local principal investigator on the trial. "Doctors use their judgment, but what treatment will work best is not known. The hope is that this study will help to further establish the best way to treat these patients."
Normally, researchers get permission (consent) before a person can be included in a study. A person having an ESE will not be able to give consent at the time they could be enrolled. Since a seizure that will not stop on its own must be treated quickly, there will not be enough time to locate and talk to the person's legal representative about the study, so the person will be enrolled in the study without his/her legal representative’s consent. This is called "Exception from Informed Consent" (EFIC). Once the representative is located or the patient wakes up, they will be asked to give their permission to continue in the study.
Temple is participating in this trial through the Philadelphia Neurological Emergencies Treatment Trials, or Phila-NETT, a National Institute of Neurological Disorders and Stroke (NINDS) sponsored network of hub and spoke hospitals conducting emergency neurological research. Temple serves as the hub for spoke hospitals, including the following hospitals that are preparing to take part in ESETT: Albert Einstein Medical Center, Hahnemann University Hospital, Crozer-Chester Medical Center, St. Christopher’s Hospital for Children and Allegheny General Hospital. Dr. Gentile heads the regional efforts of the nationwide NETT initiative that will lead the way to providing better treatment of patients with neurological emergencies such as traumatic brain injury, stroke and seizures.
For more information including an option to decline participation and to share your opinions about this study go to www.pnett.org/seizure.htm.