August 17, 2007

Mercy Participates Cardiac Arrest and Severe Trauma Research

Mercy Medical Center—Sioux City is taking part in a massive research program funded by the National Institutes of Health (NIH) and other federal and Canadian agencies that hopes to help scientists learn the best ways to improve survival chances from cardiac arrest and severe trauma.
The “Resuscitation Outcomes Consortium” (ROC) will conduct collaborative clinical trials of promising new treatments for cardiac arrest (the stopping of the heartbeat) and severe traumatic injury.

Mercy, home of the regionally and nationally recognized Mercy Heart Center and western Iowa’s regional Level II trauma center, is participating in the both the cardiac arrest and trauma studies through the University of Iowa Carver College of Medicine—Iowa Resuscitation Network. Along with Emergency Medical Services (EMS) agencies, ROC will involve public safety agencies, regional hospitals, community healthcare institutions and medical centers in 11 regions in the United States and Canada and as many as 15,000 patients over a 3-year period.

Sioux City and other communities involved in ROC will learn about the study in a comprehensive community education effort to be conducted over the next 6 months to a year.

Along with Mercy Medical Center—Sioux City, Siouxland Paramedics, Inc. and the Sioux City Fire Department will also be part of the trauma study in the Siouxland area.

“Surviving traumatic injury and cardiac arrest is a serious public health issue. Tens of thousands of Americans die each year from sudden cardiac arrest and trauma. 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,” said Elizabeth G. Nabel, M.D., director of the National Heart, Lung, and Blood Institute (NHLBI) of the NIH, the lead federal sponsor of the research effort.

This is the first time researchers have used large-scale clinical trials to improve the treatment of patients with traumatic injury and cardiac arrest.

Scientists leading the study believe all of the interventions to be tested in the new program will have been shown in smaller, single center studies to be safe and to potentially have a life-saving effect. The Consortium’s testing of new techniques will provide the large-scale proof of effectiveness needed to support widespread adoption and use.

The first treatments to be tested will be highly concentrated forms of a saline solution similar to the body’s own fluids. Typically, in the crucial early minutes before blood transfusions can be safely administered in hospital, trauma patients receive normal saline solution intravenously in the field to compensate for blood loss and buy time. In the new trial, trauma patients with either signs of blood loss or severe brain injury will receive one of three saline solutions –standard saline, high concentration saline, or high concentration saline with dextran, a circulation-enhancing substance. The two concentrated solutions are designed to compensate for blood loss more effectively, lessen excessive inflammatory responses and prevent brain swelling. These effects in turn could potentially lead to a reduction in organ failure for patients with major blood loss and improved function for patients with brain injury.

The second cardiac-related study will test a device to enhance blood flow during CPR. This device is a one-way valve that fits between the airbag used to introduce air into a person in cardiac arrest and the flexible plastic tube that goes through the nose or mouth and into the lungs to help with breathing. The valve can also be used with a facemask that goes over the patient’s nose and mouth. During CPR, the one-way valve creates a small vacuum inside the patient’s chest, which increases the return flow of blood to the heart.

Other possible future studies include testing of new drug approaches to aid resuscitation from cardiac arrest and evaluation of novel strategies to control hemorrhage.

By law and ethical standards, medical research requires that anyone who participates in a study know what the study involves and risks and benefits, if any. This is known as "prior informed consent." However, because persons in these ROC studies will be either unconscious or in cardiac arrest, they will be unable to provide informed consent.

Therefore, ROC will be conducted under federal regulations that allow for a special "Exception From Informed Consent" in life-threatening situations. Instead, consent will be obtained after treatment, when the person is no longer in the emergency situation, or when a legally authorized representative of the injured person is available.

“There is a high probability of benefit for patients participating in these trials,” said Joseph Ornato, M.D., the Consortium’s co-chair for cardiac arrest and chairman of the Department of Emergency Medicine at the Virginia Commonwealth University Medical Center in Richmond, VA. “Not only have these therapies been shown to be potentially life-saving, but also EMS personnel involved in the research will be trained in the most up-to-date and effective methods of emergency treatment.”

There are an estimated 330,000 out-of-hospital cardiac deaths each year in the United States.
Severe injury is also a major public health problem. It is the number one killer of both children and young adults up to age 44. As a disease of young people, it is also the leading cause of life years lost. In 2002, there were over 161,000 fatal injuries in the United States.

For more information about the upcoming cardiac arrest and trauma study, call 866-309-0838 (toll free), or visit www.iowarocs.org.