Medical study using severe cardiac, trauma patients is under way

By: YVETTE URREA - Staff Writer | Thursday, March 8, 2007 9:12 PM PST ∞

Paramedics countywide are trying new treatments on patients with severe trauma or cardiac problems as part of a study that aims to improve field medical care and survival rates.

All such patients are subject to the study, which started two weeks ago and continues for at least two years, unless they opt out of the treatment in advance by obtaining a special medical bracelet. A federal clause allows paramedics to treat patients during the study without getting their consent because the patient would likely be incapacitated, a trial coordinator said.

UC San Diego spokeswoman Leslie Franz said the government allows the exception only when a study treatment is highly unlikely to cause harm and is more likely to benefit the patient.

However, people who wish to be excluded from the study can obtain a special bracelet by calling (619) 471-0616.

The study, called the Resuscitation Outcomes Consortium, is being coordinated in the San Diego area by the UCSD Medical Center. The county is one of 10 areas in the United States that is participating in the study, which will also be conducted in Canada, said UCSD Emergency Medicine Dr. Daniel Davis.

Davis said that so far no one has called to request a bracelet but paramedics, who have all received special training for the program, are trained to look for it.

Davis added that the study is being evaluated at every step by federal review boards in case a patient is adversely affected. Paramedics have noted improved chances for survival in cardiac patients during training, he said.

"We just enrolled our third patient (Tuesday). It's the second week of the trial. We're just getting started," Davis said. "That last one (patient) was taken to Palomar (Medical Center) and was out of Ramona."

The study is being conducted in two parts, with the goal of increasing blood flow to the heart and lungs. During the first part, which lasts until May, doctors will evaluate the effects of a hypertonic saline administered to severe trauma patients, according to the National Institutes of Health's Web site.

Davis said paramedics do not know whether they are administering the regular saline solution normally given to patients, a more concentrated version, or a version that includes dextran, a circulation-enhancing solution.

The second part of the trial will begin in May, and will address cardiac patients. It involves a new valve that raises blood pressure while paramedics do cardiopulmonary resuscitation, and compares the results to a combination of cardiopulmonary resuscitation and a defibrillator, Davis said.

The UCSD Medical Center held a series of community meetings in February, including several in Carlsbad and Poway, to tell residents about the study and answer questions. Other meetings were held in Chula Vista and El Cajon.

-- Contact staff writer Yvette Urrea at (760) 901-4076 or yurrea@nctimes.com.