Is consent needed for trauma study?
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Patient consent is a cornerstone of modern medical research.

So there were questions when a Memphis researcher met with county commissioners recently to describe a proposed study of an experimental blood substitute - a study that would involve giving trauma patients the test product without first getting permission from them or their families.

"It was a big red flag to me," Commissioner Deidre Malone said of the study design.

But when Dr. Martin Croce finished his presentation, Malone and the other commissioners were satisfied that the study's potential benefits outweighed the risks.

Now researchers are poised to ask suburban Shelby County residents what they think of possibly waking up in The Regional Medical Center at Memphis to learn they have been enrolled in a research project.

A telephone survey will begin today of 700 to 1,000 households in Millington, Bartlett, Collierville, Olive Branch and Southaven as well as other Shelby and DeSoto County communities.

Those are unusual steps for a yearlong study that will involve only about 50 Mid-South patients.

The focus is trauma patients who are at risk of dying due to shock and blood loss. Today even if they reach the hospital alive, 15 to 20 percent die within hours or weeks.

"We'd like to cut that in half," said Croce, a University of Tennessee Health Science Center professor of surgery. He is also medical director of The Med's Elvis Presley Memorial Trauma Center.

Currently, ambulances don't carry blood. On the way to the hospital, patients are given saline solution. While that helps replace lost fluid, saline lacks blood's oxygen-carrying capacity.

Enter a product being developed for use when blood isn't available. Dubbed PolyHeme, it is manufactured by Northfield Laboratories of Evanston, Ill. Like blood, it is designed to transport oxygen throughout the body. Unlike blood, it lasts a year without refrigeration and can be given to patients regardless of blood type.

Croce said it has been given to more than 300 patients and results are promising. The main complaint has been a skin rash, although Croce said more serious complications, including a short-term blood pressure increase and even disease transmission, are possible.

This study calls for enrolling 720 patients at 20 trauma centers nationwide. The question is whether PolyHeme will cut patient deaths.

For the study, half the patients would be randomly assigned to receive the blood substitute along with the saline solution. Up to six units would be transfused as they are transported to The Med by the Hospital Wing helicopter ambulance or during their first hours of hospital care.

There is no charge to patients. They could drop out of the study any time, including as soon as they or their families learn they were enrolled.

The other study patients would receive standard care.

For the average Med trauma patient arriving by helicopter, a proven blood substitute would jump-start care. The average helicopter trip takes 20 minutes.

"That doesn't sound like a whole lot of time, but it is an eternity to someone in shock," Croce said. "To make bigger strides in reducing mortality it is clear that you have to start (treatment) earlier."

Until 1996 federal guidelines made research involving emergency medicine difficult. Rarely was there time to get permission from patients or families, so research was uncommon.

The new federal guidelines are designed to better balance patient rights with society's interest in improving emergency care.

But Dr. Terrence Ackerman, chairman of the UT department of human values and ethics, said research in which patient consent isn't required before enrollment remains rare.

He estimated fewer than a half-dozen such studies have been conducted nationwide. That includes a 1998 study involving about 20 Med trauma patients. Those patients received an experimental drug designed to prevent deadly organ damage in shock patients. Researchers had permission to give it to qualified patients even if no relatives could be found to give consent.

"I don't believe anyone was upset or withdrew from the study" after learning they had received the drug, Croce said. There were no lawsuits.

Malone said she wouldn't be upset if either she or a relative were enrolled in the proposed study without first giving consent. "But if I was the average Joe I might be uncomfortable," she said.

The 25-member UT Health Science Center institutional review board must OK the proposed study, as it does all research involving human subjects. If approved, the study could begin as early as October.

Ackerman helps run the board, which includes university and community mem bers. Although he said the experimental blood product appears promising and very safe, he said the study probably wouldn't win board approval if "a fairly substantial minority of the community opposed it."

The phone survey is just one way researchers are trying to gauge public opinion. Along with Croce's County Commission appearance, he has appeared on television. Ads detailing the study also have appeared in local newspapers.

For more information about the research or to register an opinion, call Stephanie Panzer, nurse coordinator for the study. Her number is 448-5714.


reprint courtesy Go Memphis