Henry Ford Hospital: Unique Patient Study — No Informed Consent
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 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.
For more information please visit www.detroitrampart.org.
SOURCE Henry Ford Hospital