By Jennifer Bails
Pittsburgh Tribune Review
Copyright 2006 Tribune Review Publishing Company
University of Pittsburgh doctors and local first responders will test promising new emergency treatments on patients suffering cardiac arrest or severe trauma.
The $50 million, 11-city study could affect anyone receiving emergency medical care in Pittsburgh and surrounding communities in the next two years.
“Tens of thousands of Americans die each year from sudden cardiac arrest and trauma,” Dr. Elizabeth Nabel, director of the National Heart, Lung and Blood Institute, the lead federal sponsor of the research effort, said in a statement. “The good news is that there is a growing body of research — basic research and small studies — that suggests a significant number of these people can be saved.”
Clinical trials could begin in August. Researchers will try to determine whether experimental treatments for severe trauma and cardiac arrest that were proven safe and potentially life-saving in smaller studies should be used more often.
They’ll test these treatments on as many as 20,000 patients in the U.S. and Canada, including about 1,700 in the Pittsburgh area, said Dr. Clifton Callaway, who heads the study locally.
“I think it is critical that we test these methods to see if they really work in large trials and see if they really help people return to a normal life, and give our paramedics better tools,” said Callaway, an assistant professor of emergency medicine at Pitt.
Participating emergency responders include Pittsburgh EMS in Allegheny County; Mutual Aid Ambulance Service in Westmoreland County; Fayette EMS in Fayette County; Ambulance & Chair Service in Washington County; and STAT MedEvac, which provides regional air medical transport.
One part of the trial will evaluate resuscitative fluids delivered to patients with severe head injury or shock from blood loss.
Severe traumatic injury is the No. 1 killer of children and young adults in the U.S. About 175,000 injury-related deaths occur each year.
Typically, trauma patients receive saline solution intravenously to compensate for blood loss before blood transfusions can be administered in a hospital.
In the trial, patients with signs of blood loss or severe brain injury randomly will receive either standard saline, high concentration saline, or high concentration saline with a circulation-enhancing starch solution called Dextran.
Doctors hope the two concentrated solutions will promote blood flow more quickly, lessen inflammation, reverse shock and prevent brain swelling, Callaway said.
The second part of the trial will test a device to enhance blood flow during cardiopulmonary resuscitation, or CPR, in patients who have suffered sudden cardiac arrest. Alternative methods of delivering rescue shocks to the heart also will be evaluated.
An estimated 330,000 out-of-hospital cardiac deaths occur each year in the U.S., most of them when the heart stops beating effectively, causing blood to stop circulating. Most cardiac arrest victims die before they reach the hospital.
First responders will test a one-way air valve designed to increase the effectiveness of manual chest compressions in patients receiving CPR.
The valve fits between the bag used to introduce air into the patient and the face mask that goes over the nose and mouth.
Researchers will compare two techniques for providing rescue shocks to patients in ventricular fibrillation, the abrupt disorganization of the rhythm of the heart, which stops it from pumping blood. Paramedics either will first shock the patient with an external defibrillator and then perform CPR, or vice versa.
Julie Peters, paramedic regional supervisor for Fayette EMS, said the trials should help improve the care delivered by the 65 paramedics on her staff.
“I think it will eventually lead us to the next level,” Peters said. “It is important to give patients the best care we can, and the way to start is with the studies we do.”
Patients suffering severe trauma or cardiac arrest probably won’t be able to give consent for their participation in the study, as federal law requires, so the trials have undergone extensive review by federal regulators and university officials.
The Pitt researchers will discuss the study during six regional public meetings. Two meetings will be conducted in Allegheny County: noon Friday at the university’s William Pitt Union, Fifth Avenue, Oakland, and noon July 17 at the Northland Library, 300 Cumberland Road, McCandless.