For more information:
RAMPART
System Administration
Phone: 212-305-4234
E-mail: ndo1@columbia.edu
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.
Following is information contained in the community handout. If you would like copies of the brochure, call 212-305-4234.
Do Your or a Family Member Have Seizures?
What is RAMPART?
Seizures are a common medical problem. Most seizures are brief and stop by themselves, but those that do not stop in seconds or minutes are a dangerous, life-threatening medical emergency. Paramedics often have medications that can stop the seizures, but the best way to give them is not known.
Rapid Anticonvulsant Medication Prior to Arrival Trial (RAMPART) is a proposed research study to figure out whether giving anti-seizure medicine works better and more quickly when given through an IV (in the vein) or as a shot in the muscle. Two similar medicines – midazolam and lorazepam – would be used in RAMPART. Both are already used by paramedics and doctors across the country to stop seizures. Both medications can be given by IV, but only midazolam can also be given as a shot in the muscle.
In RAMPART, participants would receive either lorazepam in the vein or midazolam in the muscle. We hope to find out which of these two medicines and which way to give it is best for paramedics to stop a person’s seizure.
How would patients be enrolled?
The RAMPART Study would involve patients who are having seizures that are not stopping by themselves. Paramedics would enroll patients who have been seizing for at least 5 minutes and are still seizing when they arrive. Adults and children estimated to weigh over 28 pounds may be included in the study.
Patients will only be enrolled if they are being brought by ambulance to a participating hospital and qualify for the study.
What would be the benefits of participation?
Because we do not know which medicine is better, a person enrolled in the study may benefit from receiving a better medicine.
Because of the information that we hope to learn from this study, patients with prolonged seizures in the future may benefit from this study as well.
What would be the risks of participation?
The two study medicines, lorazepam and midazolam, are already used everyday to treat seizures in ambulances and hospitals across the
Risks of lorazepam and midazolam are similar to those of diazepam. The most common risks include respiratory depression (slowed breathing) and excessive sleepiness. Other risks of lorazepam include pain at the IV site and behavioral changes, such as confusion, restlessness, aggression, and visual hallucinations (seeing things). Other risks of midazolam include pain at the injection site, loss of muscle coordination, and behavioral changes, such as confusion, aggression, and visual hallucinations. In the RAMPART Study, the healthcare team would monitor participants for side effects.
There is a possibility that one or the other study medicine may stop seizures more quickly. If so, some participants will get the slower of the two. In this study, however, both medicines are likely to be more effective than diazepam.
How would enrollment in the RAMPART Study be different from other studies?
Normally, researchers ask for permission before a person can participate in a study. If a person is unconscious, due to a seizure or another medical condition, researchers might ask for permission from the person’s legal guardian or family member. Prolonged seizures must be treated quickly and there is not enough time to reach and talk to a legal guardian or family member about the study in advance. In RAMPART, a person seizing will be enrolled in the study without the person or guardian’s consent. This is called “Exception from Informed Consent” (EFIC).
What is EFIC?
The U.S. Food and Drug Administration (FDA) is an agency of the federal government that oversees human research involving medications. The FDA has allowed a set of special rules, called “Exception from Informed Consent” (EFIC), to guide emergency research. EFIC allows research studies to be conducted in certain emergency situations.
Only when:
- the person is in a life-threatening situation,
- current treatments are unproven or unsatisfactory,
- the study might provide direct benefit to the person, and
- it is not possible to obtain informed consent:
- from the person because of his or her medical condition nor
- from the person’s guardian because there is a very short amount of time required to treat the medical condition.
Before researchers may do a study using EFIC, they must provide information about the study to the community and obtain their feedback.
For more information:
RAMPART
System Administration
Phone: 212-305-4234
E-mail: ndo1@columbia.edu
