The Richmond Ambulance Authority is no stranger to participating in medical trials to advance the prehospital management of patients. RAA's newest study is Neurological Emergencies Treatment Trials Network's RAMPART. It stands for Rapid Anticonvulsant Medications Prior to Arrival Trial and should not be confused with an earlier, totally unrelated study that RAA codenamed "rampart." It compares the efficacy of an intramuscular injection of one benzodiazepine (from now on referred to as "Drug X") versus an intravenous dose of a different benzodiazepine ("Drug Y") in status epilepticus patients. RAA is one of more than 36 EMS agencies in 14 states participating in the study.
.jpg)
The RAMPART box. Images: S. Mease.
Status epilepticus (SE or often simply "status") is prolonged seizure activity or multiple seizures with no intervening periods of consciousness. The RAMPART protocol book reports that there are anywhere between 120,000 and 200,000 cases of SE in the United States every year. Approximately 55,000 of those are fatal. Some of the complications of SE are apnea, hypoxia and resultant hypoxic injury, and cardiac dysrhythmias including cardiac arrest. SE can also cause hyperkalemia, hyper- and hypoglycemia, and cerebral edema. One episode can lead to a future of increased seizure activity and the likelihood of more episodes of SE. It is a true medical emergency requiring rapid intervention.
This is where the RAMPART study comes in. There are several benzodiazepine anticonvulsants currently being used in Virginia, including Versed, Valium and Ativan. However, there is not enough data comparing Drug X with Drug Y for the prehospital treatment of status epilepticus. The RAMPART study is a double-blind randomized non-inferiority clinical trial testing the efficacy of the Drug X versus Drug Y. Both drugs in the study have been successful anticonvulsant medications for many years. This trial does not involve any experimental drugs. NETT hopes to enroll 800 adult and pediatric patients in the study.
The adult autoinjector.
The primary objective of the RAMPART study is to determine how Drug X's efficacy compares to that of Drug Y for the prehospital treatment of status epilepticus. The efficacy is determined by the percentage of patients whose seizure activity has ceased upon arrival at the emergency department after one dose of the study medication. One of the secondary objectives is "to assess the rapidity of [Drug X] versus [Drug Y]." The rapidity is determined by comparing the duration of the seizure activity from the time the paramedic arrives on scene and from the time the medication is administered. Another objective is to compare the two medications' effects on the "frequency of endotracheal intubation, the frequency and duration of hospitalization and of ICU admission, and the frequency of acute seizure recurrence."
Any patient in status epilepticus meeting the inclusion criteria and not meeting any exclusion criterion is enrolled in the study. To be included, a patient must have experienced at least five minutes of continuous seizure activity or have rnultiple seizures without regaining consciousness. The patient must be seizing upon EMS arrival; if not, s/he must be unresponsive and have another generalized seizure without regaining consciousness. Only patients actively seizing are enrolled. Pediatric patients must weigh at least 13 kilograms (approximately 29 pounds). The patient must be transported to a RAMPART participating hospital, which in Richmond is the VCU Medical Center.
The pediatric autoinjector.
The medical exclusion criteria are major trauma as the cause of the seizure, blood glucose level of less than 60 mg/dL, known allergy to either medication, cardiac arrest, or significant bradycardia defined as a heart rate less than 40 beats per minute. Other exclusion criteria are a medical alert bracelet reading "RAMPART declined," known pregnancy, incarceration or house arrest. Patients cannot be enrolled if they have already received Valium via autoinjector for the seizure. In addition, if the patient's family does not want the patient transported to VCU, s/he cannot be enrolled.
EMS crews are given a randomized study box each shift. The box contains a color-coded adult and pediatric kit. Each kit consists of an autoinjector and a syringe, with one containing the medication and the other containing the placebo. The box has a voice recorder so all the events are time-stamped. After a rapid initial assessment, the patient immediately receives the IM injection to the thigh via autoinjector. The paramedic then obtains IV or IO access. If the patient is still seizing after five minutes, the paramedic will administer the contents of the IV syringe. The patient is assessed for ten minutes if time permits. If the seizure activity has not ceased after ten minutes, the paramedic administers a benzodiazepine per local protocol. If the patient stops seizing at any time, with or without regaining consciousness, their participation in the study ends, even if they start seizing again.
According to the RAMPART website, RAA has enrolled over 40 patients as of February, 2010. Nationwide, nearly 400 people have been enrolled so far. The study is expected to continue until December, 2012. Whatever the results, prehospital treatment of status epilepticus will improve thanks to the work of RAA and the other participating agencies.
Sources:
- FW Drislane, "Complications of status epilepticus : Epilepsy.com/Professionals." Epilepsy.com
- Neurological Emergencies Treatment Trials, "RAMPART Welcome."
- Neurological Emergencies Treatment Trials, "RAMPART Protocol."
Follow Elle on Twitter for the latest updates on the central and eastern Virginia emergenscene. Feel free to email her at RichmondEMSExaminer@gmail.com, she'll love to hear from you. To read more about central and eastern Virginia EMS, check out the Richmond EMS Examiner homepage. New articles are added daily, so subscribe, bookmark or get the RSS feed to make sure you don't miss a thing. Spread the word!
Comments