News Release: Research, School of Medicine
Jun. 30, 2009
Emory Doctors Study Seizure Medications Given Prior to Emergency Room Care
The Emory University Department of Emergency Medicine, working closely with Grady EMS, is one of a select number of emergency departments in the United States that will participate in a clinical study for treatment of patients who are having prolonged epileptic seizures.
The Rapid Anticonvulsant Medication Prior to Arrival Trial (RAMPART) is designed to study whether giving an anti-seizure medicine works better and more quickly when given through an IV (in the vein) or as an injection in the muscle. Two similar medicines - Midazolam and Lorazepam - will be used in the RAMPART study - both of which are already used by paramedics and doctors across the country to stop seizures.
As part of the study, treatment will begin before arrival to a hospital - either at the scene or in the ambulance - and may continue through the transport to the hospital. The patient will receive an injection into a muscle (IM) and an injection into a vein (IV) with either Midazolam or Lorazepam. Both of these medications are currently used for treating seizures in the emergency setting, but Midazolam is not FDA approved for the treatment of seizures.
According to Matthew Bitner, MD, the Emory principal investigator, because it is not possible to obtain informed consent from a patient who is seizing, this study uses a provision known as Exception from Informed Consent (EFIC).
"Under normal circumstances and traditional guidelines, researchers would ask for permission before a person can or does participate in a clinical study," says Bitner. "And in the event a patient is unconscious - due to a seizure or another medical condition - researchers would ask for permission from the person's legally authorized representative.
"But since prolonged seizures must be treated very quickly - often even before a patient is placed in an ambulance for transport to a hospital - there might not be enough time to talk to a legal guardian or family member about the study," says Bitner.
"During the RAMPART study, however, a person seizing could be enrolled in the study without the person or legally authorized representative's consent," explains Bitner. "This is what we call ‘Exception from Informed Consent.'"
Because public disclosure and community consultation are vital requirements for approval of this type of study and for maintaining integrity and public trust in the critical value of such clinical trials, either the patient or the patient's legally authorized representative will be contacted after arrival to the emergency department to obtain consent to continue the persons participation in the study.
Because the study affects a very small segment of the population, Emory is working diligently to alert those individuals, primarily those most susceptible to epileptic seizures, to this trial in advance of its start.
"If a person decides that he or she is not interested in participating for any reason, they may call us or send us an e-mail with contact information," explains Harriet Howlett-Smith, RN, clinical research nurse and program supervisor in the Emory Department of Emergency Medicine. "We will then provide an identification bracelet with the words "RAMPART declined" imprinted. One would need to wear this bracelet at all times throughout the three years of the study if they do not wish to participate. If they do not participate in the study, of course, they will receive the standard treatment delivered by paramedics."
"Through our communications with the public, via town hall style meetings, forums, e-mails and other methods, the feedback has been tremendous," Howlett-Smith continues. "People, especially those who suffer from severe seizures and know the dangers and implications, greatly appreciate our efforts to inform them of this study, as well as being given the option not to participate. We have received overwhelming support, but we still want to keep communications fresh and ongoing."
Seizures are a fairly common medical problem, and are usually brief and stop without treatment. But those that do not stop in seconds or minutes are a dangerous, life-threatening medical emergency. Paramedics are equipped with medications that can stop the seizures, but the best way to provide these medications (either through IV or IM injection) for rapid control is not yet known.
A prolonged seizure - also known as Status Epilepticus - is a condition where epileptic seizures do not stop on their own or occur repetitively without the patient returning to normal in between the seizures. Epilepsy is a chronic neurological disorder that produces brief disturbances in the normal electrical functions of the brain, causing recurrent seizures. It can be genetically present from birth or caused by a head injury, brain tumor or stroke.
"Status Epilepticus is a true emergency associated with significant disability and death, says Dr. Bitner. "It is estimated that there are between 120,000 and 200,000 cases of Status Epilepticus in this country each year resulting in as many as 55,000 deaths. Prolonged seizures may cause a host of complications including difficulty breathing, abnormal heart rhythms, and an altered level of consciousness as well as cause permanent injury to the brain and/or nervous system."
Patients who suffer a head injury have a 50 percent chance of developing epilepsy within two years. More than 3 million people in the United States have some form of epilepsy, which can result in severe physical convulsions, loss of consciousness or short-term memory loss.
Patients who wish to opt out of the study may do so either by phone at 404-778-1710, or via e-mail at: RAMPART.trial@emory.edu.
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The Robert W. Woodruff Health Sciences Center of Emory University is an academic health science and service center focused on missions of teaching, research, health care and public service. Its components include schools of medicine, nursing, and public health; Yerkes National Primate Research Center; the Emory Winship Cancer Institute; and Emory Healthcare, the largest, most comprehensive health system in Georgia. The Woodruff Health Sciences Center has a $2.3 billion budget, 17,000 employees, 2,300 full-time and 1,900 affiliated faculty, 4,300 students and trainees, and a $4.9 billion economic impact on metro Atlanta.
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