Penn State Milton S. Hershey Medical Center Department of Emergency Medicine is participating in a clinical research study called RAMPART - the Rapid Anticonvulsant Medications Prior to Arrival Trial. This is a national trial being conducted at many major hospitals, including our partner Temple University.
Learn more about RAMPART:
This is an exception from informed consent study, meaning that patients who do not want to participate in this study must notify the Medical Center prior to needing EMS services.
What is RAMPART?
RAMPART is a research study to figure out whether giving anti-seizure medicine works better and more quickly when given through an IV (a tiny straw or tube in the vein) or when given IM (as a shot in the muscle). Two similar medicines - midazolam and lorazepam - will be used. Lorazepam is commonly given IV, and midazolam is commonly given IM. Both are already used by paramedics in the field and by doctors in the hospital to stop seizures.
Researchers want to find out if an injection of medication (midazolam) in the muscle is as effective as medication (lorazepam) given by an IV for stopping seizures.
To find out, persons having seizures are randomized to one method or the other. Randomizing is like flipping a coin, one patient gets one method, one the other. The groups of patients are then compared.
Seizures can cause possible brain damage from either low blood oxygen levels or by direct nerve injury. Seizures can also cause muscle and kidney damage, or even death.
Status epilepticus is the most severe and life-threatening kind of seizure. It takes two forms:
- A seizure that lasts more than five minutes without stopping.
- Multiple seizures occurring back-to-back without the patient returning to normal between each seizure.
Medications used to treat seizures are called benzodiazepines. The drug diazepam is used by EMS and available for home use; midazolam is used in hospitals and a few EMS services; and lorazepam is used in hospitals.
The RAMPART study is looking at the effectiveness of midazolam, injected into the muscle, compared to the use of lorazepam, given via an intravenous line into a vein, to determine the best drug to use to terminate status epilepticus events.
Who can participate?
If a person is actively having a seizure when EMS arrives, the person will be considered for enrollment into this research project. Communities served by LifeLion EMS are eligible for this study (Hershey, Hummesltown, Palmyra, Lower Swatara Township, South Hanover Township, North Londonderry Township, South Londonderry Township, and Conewago Township).
Who cannot participate:
- Anyone wearing a “opt out” or RAMPART declined bracelet.
- Anyone who is pregnant.
- Prisoners, even those on house arrest or simply in police custody.
- Anyone with an i.v. already established prior to E.M.S. arrival.
- Anyone with a pulse less than 40 beats per minute despite using medicines to speed the heart and providing extra oxygen.
- Anyone with a low blood sugar level.
- Anyone allergic to the medications for seizures that are carried by EMS.
- Anyone weighing less than 13 kilograms (29 pounds).
- Anyone whose seizure is related to trauma (for example, a blow to the head).
Which medicine do you get?
Persons who receive a midazolam shot in the muscle will also receive placebo (sterile saltwater called a “saline flush”) by an IV.
Persons who receive lorazepam by an IV will also receive a placebo (saline) shot in the muscle.
Both medications are approved for treatment of seizures. The person will never receive two doses of medication or two doses of placebo. This way no one knows which medication a patient is getting, but every patient will receive seizure medication treatment.
If the seizure does not stop after ten minutes EMS will follow their normal procedure and may give more medication to the patient.
What about asking permission?
Seizure medication must be given right away to prevent life threatening complications. There is no time to ask the patient or their family for consent. Seizure medications must be given in the ambulance right away.
Once the patient is at the hospital, consent will be asked to continue with the study.
Medical information will be collected until the patient is discharged from the hospital.
Feedback wanted
Community consultation: Researchers will be available to talk about this study at a number of public meetings and events:
- December 9, 2009 Dauphin County Commissioners Meeting, 10:00am
- December 14, Cumberland County Commissioners Meeting, 2:00pm
- December 17, Lebanon County Commissioners Meeting, 9:45am
- December 23, University Conference Center, 9:00am
Call: 717-531-1707 option 5
Principal investigator of this study is Christopher Vates, M.D.
The IRB and the Human Subjects Protection Office can be reached by calling 717-531-5687
