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. A person whose seizure does not stop even after receiving a full dose of medicine (benzodiazepines) to make it stop is considered to have Established Status Epilepticus (ESE).
ESETT is 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 a benzodiazepine (like valium). This study plans to look at three commonly used medicines given in the emergency departments to treat ESE: fosphenytoin (fPHT), valproic acid (VPA), and levetiracetam (LVT) to learn which treatment is most effective at stopping a seizure quickly.
Led by Principal Investigator Charles Wira, MD, Yale researchers plan to join multiple hospitals across the country in the ESETT trial and enroll patients at Yale-New Haven Hospital.
Q&A with Charles Wira, MD about ESETT, a new treatment trial for patients with severe seizures.
What is SE?
Status Epilepticus (SE) is defined as a seizure or recurrent seizures lasting longer than five minutes without stopping or waking up.A person whose seizure does not stop after receiving a full dose of medicine (benzodiazepines) to make it stop is considered to have Established Status Epilepticus (ESE).
A prolonged seizure can:
- Happen to someone of any age
- Affect one’s ability to think and remember
- Prevent a person from being able to function normally or independently
- Limit awareness and cause coma
- Cause permanent brain damage
- Cause death
What is ESETT?
Emergency department care of Established Status Epilepticus (ESE) in the US is not the same everywhere. Doctors use their judgment, but what treatment will work best is not known. The purpose of this study is to find out which of three commonly used medicines given in the emergency department for (ESE) is safer and more effective.
- fosphenytoin (fPHT),
- valproic acid (VPA), and
- levetiracetam (LVT)
Who will be included?
- Any patient who is 18 years or older with an
- Active recurrent or ongoing seizure lasting longer than five minutes, and
- Has already received an adequate dose of benzodiazepine (like valium) in the past 5-30 minutes to make the seizure stop could be enrolled.
How is enrollment in ESETT different from other studies?
Normally, researchers get permission before a person can be included in a study. A person having a seizure will not be able to give consent. 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. All patients 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 told about the study and asked to give their permission to continue in the study.
What is EFIC?
The U.S. Food and Drug Administration (FDA) is an agency of the federal government that oversees human research protection involving medicines. The FDA has created a set of special rules, called “Exception from Informed Consent” (EFIC). These special rules allow research studies in certain emergency situations to be conducted without consent.
EFIC can only be used when:
- The person’s life is at risk, AND
- The treatments we have don’t work, AND
- The study might help the person, AND
- It is not possible to get permission:
- from the person because of his or her medical condition nor
- from the person’s guardian because there is a very short amount of time required to treat the medical problem
Before researchers may do a study using EFIC, they must provide information about the study to the community and get their feedback.
How can I share my opinions about this study?
Before the study starts, meetings will be held in the community to provide information, answer questions and get community members’ thoughts and feelings about the study. You can call the study team to complete a one-on-one interview about the study. There will also be information about the study in the media (for example, newspapers, TV and radio).
What if I do not want to be included in the study?
There are two methods for opting out:
1. Through a Medic Alert™ membership. If you have an existing medic alert tag or bracelet you can add “ESETT Study Declined” to it. If you have a medic alert membership you can add “ESETT Study declined” to your Emergency Medical Information Record. If you would like to find out more information about your existing medic alert services or for a new membership visit: www.medicalert.org
2. Call us to request an Opt Out bracelet be sent to you to wear with the words “ESETT declined”. You will need to wear this bracelet at all times during the study period (approx.5 years), or else you could be enrolled.
If you do not participate in the study, you will receive the standard medical treatment provided for established status epilepticus at the hospital in your community.
Where can I learn more about the study?
To learn more, including an option to decline participation, go to www.esett.org, or see the information attached.