The data that we collect in the ESETT Trial will enable physicians to determine best practices and create a standard protocol for emergency treatment of ESE that will yield the best possible outcomes for patients, no matter where they are treated.
Pittsburgh, PA (PRWEB) August 12, 2015
Allegheny General Hospital, part of the Allegheny Health Network, is one of 39 medical centers across the United States participating in a clinical trial to help determine better ways to treat patients with prolonged seizures in Emergency Departments.
Currently, there is not a standardized protocol for emergency treatment of Status Epilepticus (SE), a seizure or recurrent seizures lasting longer than five minutes without stopping or waking up. A person whose seizure doesn’t stop after receiving a full dose of medicine designed to stop seizures is considered to have Established Status Epilepticus (ESE).
The Established Status Epilepticus Treatment Trial (ESETT) will study three commonly used medicines given in the Emergency Department for ESE, phenoytoin, valproic acid and levetiracetam, to determine which of these is safest and most effective.
“Physicians use their best judgment to treat seizures in an emergency setting, but there currently is no substantial clinical evidence to show that one medication stands out above the rest,” said Andrea Synowiec, DO, principal investigator of the study at Allegheny General.
“The data that we collect in the ESETT Trial will enable physicians to determine best practices and create a standard protocol for emergency treatment of ESE that will yield the best possible outcomes for patients, no matter where they are treated.”
Prolonged seizures can happen to people of any age, affecting the ability to think and remember, function normally and live independently. In serious cases, SE may limit awareness or cause coma, permanent brain damage or death. There are approximately 120,000 to 180,000 episodes of SE each year in the United States.
The ESETT trial will involve any patient 2 years or older with an active recurrent or ongoing seizure lasting longer than five minutes which fails to respond to a full dose of medication that should stop it. Patients will randomly receive one of the three study medications and blood samples may be taken. If the seizure does not stop, physicians will give extra medication, which could be one of the three study drugs or a different medication.
Because a person having a seizure is unable to provide consent to participate in research and the requirement of timely treatment makes it impossible to get consent from the patient’s family, patients will be enrolled without consent. This Exception from Informed Consent is lifted once the patient wakes up or his or her legal representative is located and the study team can inform them about the trial and request permission to continue in the study.
The ESETT study is part of the Neurological Emergencies Treatment Trials and Pediatric Emergency Care & Applied Research Network, which are funded by the National Institutes of Health. In addition to Allegheny General Hospital, UPMC Presbyterian Hospital and Children’s Hospital of Pittsburgh will also enroll patients in the ESETT trial.
To learn more about the study, including the opportunity to decline participation, visit http://www.esett.org or call 412.359.5075.
About Allegheny General Hospital
Allegheny General Hospital’s Neuroscience Program has long been regarded as one of the nation’s leading referral centers for the treatment of brain injuries and complex neurological diseases, including epilepsy. The Comprehensive Epilepsy Program at AGH was established in 1987 and has become one of the largest such services in the tri-state area. Along with diagnostic expertise, the program offers advanced medical and surgical treatments for epilepsy. AGH is a member of the National Association of Epilepsy Centers and has earned the Association’s highest Level 4 designation.