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Va. Cities to Join Blood Substitute Study




 

Paramedics in Norfolk and Richmond could begin giving an experimental blood substitute to badly injured people by July, medical officials said.

The cities are two of about 20 localities nationally participating in a research project that has raised concerns about the patient consent process.

The blood substitute, PolyHeme, will be given to people who might otherwise go into shock from excessive blood loss and die before they can get to a hospital and get regular blood transfusions.

Patients are likely to be incapacitated or unconscious and unable to give the informed consent that is typically required of participants in medical research.

"Have you ever been in the emergency room with someone who has had their chest blown open and seen them bleed to death?" asked Dr. Leonard Weireter, a professor of surgery at Eastern Virginia Medical School and lead researcher for the Norfolk study.

"The issue is not consent," he said. "It's whether someone will live or die."

Federal officials who regulate medical research on humans are allowing the research under special conditions, which include a public notification and discussion process. People can opt out of the research in advance by wearing a plastic bracelet being provided by researchers.

PolyHeme is made by Northfield Laboratories Inc. in Evanston, Ill.

Unlike saline, which is typically administered by rescue personnel, PolyHeme can carry oxygen, which physicians say should improve the chance for survival.

In Richmond, Virginia Commonwealth University will coordinate a yearlong local study involving 40 trauma patients: 20 will receive PolyHeme and 20 in a comparison group will get saline, said Dr. Therese Duane, VCU assistant professor of surgery and lead researcher for the Richmond arm of the study.

"This is groundbreaking," Duane said. "In trauma patients, blood becomes a vital part of what we can provide, and we often cannot provide it soon enough. This is where this product would be extremely helpful."

Duane said she is meeting with community leaders in the coming weeks. After the public notification and discussion periods, research reviews boards at EVMS and VCU individually have to approve the projects moving forward.

A three-week training course will teach paramedics how to give the product and whom to give it to. Children and pregnant women are excluded from the study.

The search for a blood substitute has been under way for years. Blood carries oxygen to the body's tissues. Without oxygen, organs shut down and a person eventually dies.

But blood is not always readily available when it is needed. It has a limited shelf life, has to be matched to the patient's blood type and must be screened for diseases and germs. Also, blood is increasingly in short supply as more people are excluded from donating blood because of potential or actual exposure to infections such as West Nile virus and HIV.

PolyHeme is made from oxygen-carrying hemoglobin extracted from human red-blood cells. It is purified, then chemically altered.

In Norfolk, to meet the public notification requirements, officials will hold public meetings over the next six weeks. After that time, an EVMS research review board, which includes representatives from the community, will decide whether to allow the research to proceed.

A similar format will be followed in Richmond, Duane said.



 


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Information in this article was accurate in April 23, 2004. The state of the art may have changed since the publication date. This material is designed to support, not replace, the relationship that exists between you and your doctor. Always discuss treatment options with a doctor who specializes in treating HIV.