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NewYork-Presbyterian Hospital to Begine Studying Seizure Medications
NewYork-Presbyterian Hospital to Begine Studying Seizure Medications
The NewYork-Presbyterian Hospital is one of a select number of Emergency Departments in the United States considering participation in a clinical study for treatment of patients who are having prolonged seizures.
Prolonged seizures also called, Status Epilepticus, is a condition where seizures do not stop on their own or occur repetitively without the patient returning to normal in between the seizures. Status Epilepticus is a true emergency associated with significant disability and death. 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. Complications of prolonged seizures may include trouble breathing, abnormal heart rhythm, altered level of consciousness and injury to the brain or nervous system.
For this study, study treatment will begin before arrival at the hospital, either at the scene or in the ambulance.. The patient will receive an injection into a muscle (IM) and an injection into a vein (IV). Patients will receive either midazolam IM or lorazepam IV. All patients will receive one dose of active seizure medicine. Both of these seizure medications are FDA approved and are currently used to stop seizures in the emergency setting.
Because it is not possible to obtain informed consent from a patient who is seizing, this study uses a provision for an exception from informed consent, known in short as EFIC. Public disclosure and community consultation are requirements for approval of this type of study. The patient or the patient’s family will be notified about what has already taken place and consented for continued study participation after arrival at the Emergency Department. The purpose of this handout is to notify our community about this trial and to provide contact information and resources where you can learn more.
The local RAMPART phone line is 212-305-4234.
The national number is 1-866-929-NETT (6388)
The National website to learn more about this and other NETT trials is
http://nett.umich.edu.
