Clinical trial receives national recognition

May 6, 2013

A national clinical trial on the treatment of seizures that WellSpan York Hospital participated in has been named The Clinical Trial of the Year by The Society for Clinical Trials.

Doctors, researchers and paramedics at WellSpan York Hospital and other local EMS agencies joined researchers at the University of Pennsylvania School of Medicine and 16 other universities across the country to conduct a seizure study called RAMPART.

Most seizures are brief and stop by themselves, but seizures that don’t stop in minutes are a life-threatening medical emergency.

Paramedics carry medications on board ambulances that can stop seizures, but the best way to administer them was not known.

The RAMPART study aimed to find out whether anti-seizure medication works better when given via I.V. directly into a vein or when given as a shot in the muscle.

The clinical trial concluded that seizures should be treated by paramedics with a single, emergency shot of midazolam in the thigh muscle the way EpiPens are used to treat allergic reactions, rather than a procedure that involves an I.V. and lorazepam while the patient is convulsing.

WellSpan York Hospital enrolled 26 patients in the pre-hospital study.

Dan Bledsoe, M.D., of the WellSpan York Hospital Emergency Department, who oversaw the clinical trial, said, “The study’s results were what we expected, but for the first time we have conclusive evidence that intramuscular midazolam is the faster method.”

He added, “The results of this clinical trial will have a far-reaching impact. It will change the way health care is delivered. It’s rewarding and satisfying to have been part of this clinical trial.”
Pennsylvania is in the process of changing its pre-hospital protocol based on the results of the clinical trial.

“The shorter the seizure time, the better it is for the patient,” said Bledsoe. “The longer the seizure, the greater the risk it will intensify and the patient will develop complications.”

On average, seizures lasted 90 seconds after patients were given a shot of midazolam, while the average was five minutes after the administration of I.V. lorazepam, according to the study.
Bledsoe said the clinical study earned recognition because “it did everything a good clinical trial should do. It involved an incredible number of people and a variety of demographics to prove that the method will work anywhere.”

Being involved in the clinical trial provided the experience to work as one with universities and researchers across the country and increase the education of local paramedics, according to Bledsoe.
“We hope to be involved in more clinical trials to answer important research questions and help shape the future of pre-hospital care,” he said.