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Henry Ford Hospital: Unique Patient Study -- No Informed Consent

DETROIT, May 8 /PRNewswire/ -- Henry Ford Hospital is embarking on an unusual study intending to reduce brain damage or death of patients resulting from prolonged seizures before arriving at the hospital.

But because the patients are unconscious during the seizure, they will not be able to provide informed consent to participate in the study.

The Food and Drug Administration created regulations for research to be performed during emergency conditions without informed consent of the participant. Once patients awaken from the seizure their consent will be sought to continue in the study.

The study will involve patients with seizures lasting longer than five minutes that are being transported by EMS. Stopping the seizure as soon as possible is important to prevent brain-damage or death. Often the underlying cause of the seizure is unknown, but some causes include previous trauma, stroke, tumor, or infection.

The study, called RAMPART, will compare an intramuscular injection of midazolam (Versed) to an intravenous (IV) dose of lorazepam (Ativan). Both drugs are better than the most common current prehospital treatment for seizure, IV diazepam (Valium). The goal is to determine if an auto-injector with midazolam can stop seizures as fast as starting an IV and giving lorazepam.

The benefits include shorter seizures, more rapid drug administration, development of an auto-injector that could be used by non-medical personnel, and avoidance of multiple IV attempts on a seizing patient.

The three-year RAMPART study is being conducted at 17 centers around the United States. It is coordinated by the University of Michigan and funded by the National Institute of Neurological Diseases and Stroke which is a part of the National Institute of Health. Wayne State University/Detroit Medical Center is also participating in RAMPART.

The study will be conducted in conjunction with Detroit EMS. Any patient that is actively seizing upon arrival may be eligible to participate in the study. The patients must meet the inclusion and exclusion criteria of the study and be transported to either Henry Ford Hospital, Detroit Receiving Hospital, or Sinai-Grace Hospital to be included in the study. Other hospitals may be added later.

The Henry Ford Hospital Institutional Review Board (IRB) will review and monitor the study. Taher Vohra, M.D. and Christopher Lewandowski, M.D., both of the Department of Emergency Medicine at Henry Ford Hospital, are currently meeting with community groups to get their opinions on the study. Following these meetings, the Henry Ford Hospital IRB will review the process and determine final approval to conduct the study. The study is expected to start this summer.

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SOURCE Henry Ford Hospital
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