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-Wes Ogilvie

Austin, Texas

Dallas to test resuscitation techniques

Cardiac, trauma patients in city may get new treatment as part of large clinical

trial

12:03 AM CDT on Tuesday, July 11, 2006

By EMILY RAMSHAW / The Dallas Morning News

Dallas is one of 10 North American cities chosen to participate in the

largest-ever clinical trial of resuscitation methods, a designation local

doctors and researchers say will make North Texas one of the " safest places in

the country to have a heart attack or a car wreck. "

The $50 million federally funded study, which kicks off this summer and will

involve about 15,000 cardiac arrest patients and 5,000 severe-trauma victims

over the next three years, will compare traditional life-saving techniques with

two new resuscitation treatments – a unique airway valve and a highly

concentrated saline solution.

UT Southwestern Medical Center is coordinating Dallas' resuscitation research

center, which will train paramedics and collect data from more than 30

Dallas-area hospitals and 11 emergency-response agencies participating in the

National Institutes of Health-sponsored study.

" The implications of this thing are tremendous, " said Dr. Pepe, chief of

emergency medicine at UT Southwestern. " We're a center of excellence, and that's

why they chose us. "

The study means Dallas heart attack and trauma victims being treated by

paramedics at the scene or in ambulances will be randomly assigned to the

traditional treatment or to a trial treatment.

Starting in August, local trauma victims who lose significant amounts of blood

or have severe brain injuries will receive a standard saline solution or one of

two high-concentrate solutions, which experts believe more quickly restore

circulation in bleeding patients.

By November, heart attack victims will be treated with a traditional ventilator

or one fitted with an " inspiratory threshold device. " The device is an airway

valve that creates a vacuum to return blood to the chest during CPR, improving

flow to the brain and heart.

The study is double blind, meaning the thousands of North Texas paramedics being

trained for the trial won't know which kind of saline they're using or whether a

ventilator is fitted with an active or inactive airway valve. The equipment will

be specially coded for researchers.

In the U.S., about 1,000 people a day die prematurely because of heart attacks;

in Dallas, more than 1,000 people suffer cardiac arrest each year.

Trauma is the leading cause of death for children and people younger than 45. In

Dallas County, about 3,500 people die of severe injuries every year.

Traditionally, it's been difficult to conduct clinical trials on patients who

are severely injured because they are too sick or incapacitated to give informed

consent, said Dr. ph Minei, vice chairman of surgery at UT Southwestern and

an investigator in the study.

In this trial, each patient will receive, at a minimum, the current standard of

care. But residents concerned about being subject to a trial without their

consent can call to receive a special wristband.

" What we're doing now is letting the community know we're doing this trail, " Dr.

Minei said. " This is an opportunity for Dallas, and for the whole trauma system,

to really deliver a potentially lifesaving technique. "

Both trial techniques have proved to be safe and have some lifesaving effects in

smaller-scale studies in the U.S. and Europe, Dr. Pepe said.

The concentrated saline is equivalent to two bags of normal saline and can be

administered faster, potentially reducing brain swelling and preventing organ

failure in trauma victims, said Dr. Ahamed Idris, principal investigator for

Dallas' resuscitation research center.

In North Texas, Dr. Idris estimates about 500 patients per year will receive the

" hypersaline. "

The airway valve has been shown to double blood flow during cardiopulmonary

resuscitation by drawing blood up from the legs and abdomen, he said. It will

probably be used on 1,000 North Texas cardiac arrest patients per year.

Permanent brain damage can occur within four minutes after a person stops

breathing.

" We hope to be able to answer the most important question, " Dr. Idris said.

" Will these treatments return people to a normal life? "

The trial will be the first of several NIH resuscitation studies over the next

five years to determine whether particular treatments improve survival and

hospital discharge rates. Whether they prove effective, Dr. Pepe said, the mere

attention and focus of a trial this size will seriously benefit Dallas heart

attack patients and accident victims.

" Experience has shown us that survival rates go up significantly in cities that

provide this kind of research initiative for their citizens, " he said.

UT Southwestern was one of more than 100 city-university partnerships to apply

for the resuscitation study.

Other U.S. regions chosen include Birmingham, Ala.; Iowa City, Iowa; Milwaukee;

Portland, Ore.; Seattle and King County, Wash.; Pittsburgh; and San Diego. In

Canada, Toronto and Ottawa were selected for the trial.

Dallas-area residents who don't want to be included in the trial without their

consent can opt out by calling .

E-mail eramshaw@...

BY THE NUMBERS

HEART ATTACK

300,000

out-of-hospital cardiac arrests annually in the U.S.

95

Percentage of these patients who will die from those cardiac arrests

1,100

people have cardiac arrest in the city of Dallas each year, on average

TRAUMA

120,000

injury-related deaths annually in the U.S.

10,000

people injured badly enough in Dallas County annually to be transported and

admitted to a trauma center

3,500

people in Dallas County who die from trauma or serious injury annually

SOURCES: UT Southwestern Medical Center; Dallas County medical examiner's office

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