News Release: Emory Healthcare , Research , School of Medicine

Feb. 14,  2011

Emory Completes RAMPART Seizure Medication Study - Residents who opted out of trial may now stop wearing bracelet

ATLANTA – The Department of Emergency Medicine at Emory University has completed its participation in a clinical research study called RAMPART, the Rapid Anticonvulsant Medications Prior to Arrival Trial.

This nation-wide study has reached its enrollment target and has stopped enrolling patients across the country. RAMPART was an EMS trial designed to study if a seizure drug given as a shot in the muscle was just as effective as a seizure drug given through an IV into the vein at stopping seizures.

Residents within the communities served by Emory Hospital, Grady Hospital, Emory Midtown Hospital, and Children’s Healthcare of Atlanta who opted-out of the trial by wearing a “RAMPART Declined” bracelet can now stop wearing this bracelet.

The Department of Emergency Medicine worked closely with Grady EMS, and was one of a select number of emergency departments in the United States to participate in the clinical study for treatment of patients suffering from 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 was delivered before arrival to a hospital - either at the scene or in the ambulance - and may continue through the transport to the hospital. Patients received 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.

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 were contacted after arrival to the emergency department to obtain consent to continue the persons participation in the study.

Because the study affected a very small segment of the population, Emory worked diligently to alert those individuals, primarily those most susceptible to epileptic seizures, to this trial in advance of its start – and is now taking similar proactive efforts in announcing the end of the study.

Results from this study will be released to the local public and will also be available on the RAMPART website at www.rampart.umich.edu after the data has been analyzed.

For more information, please contact the Emergency Neurosciences research office at 404-778-1707 or at email address EMERGENCYNEUROSCIENCES@LISTSERV.CC.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.

Learn more about Emory’s health sciences:
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Web: http://emoryhealthsciences.org

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