Greater Cincinnati's leading trauma center wants to find out whether artificial blood really works.
But before researchers test it, they want to know whether the community supports the project, including the idea of using artificial blood on patients without their consent.
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To comment
To register an opinion about the artificial blood trial proposed to start this fall at University Hospital, write or call researchers at:
University of Cincinnati,
Department of Surgery
Trauma Research
231 Bethesda Ave.
Cincinnati OH 45267-0558
(513) 558-3850.
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It will be the first time in Cincinnati history that public opinion will directly influence the launching of a clinical trial.
The new product may help save lives when people suffer massive injuries from car accidents, shootings or stabbings.
But to find out how well artificial blood works, researchers at the University of Cincinnati and University Hospital need to try the product in real trauma victims. In many cases, the patient will be unconscious and there won't be time to find a relative to sign a consent form.
Beginning Wednesday, advertisements are scheduled to appear to give notice and solicit public comment about artificial blood.
"We're trying to come up with an acceptable plan to inform the community about the study and to get their input," said Dr. Fred Luchette, a trauma surgeon and the lead researcher for the UC artificial blood study. "If the community feels we should proceed, the clinical trial would start this fall."
The experiment involves a type of artificial blood that has been in development for several years - a product called HemAssist, made by Baxter HealthCare Corp. of Deerfield, Ill. If the public approves, UC would become one of nine trauma centers nationwide to test the product.
The Cincinnati study would involve about 30 patients for one year. The patients would be among the most severely injured who come to University Hospital's emergency department. The injuries will be so severe that only 50 percent of patients would normally be expected to survive, Dr. Luchette said. The hospital sees about 100 such patients a year.
HemAssist is not blood, but it is made from human blood. The product is a chemical solution containing large amounts of hemoglobin, the key oxygen-carrying protein normally found in red blood cells. The main idea behind HemAssist is to save lives by saving time. Unlike regular blood, the product can be used in anybody without doing cross-match tests to check for blood type - which can take an hour.
Doctors also think the smaller particles in the artificial blood will be more effective than larger, whole red blood cells at preventing organ damage in cases of traumatic shock.
In previous tests, more than 350 patients have received the artificial blood without experiencing any significant, harmful side effects, Dr. Luchette said. This latest round of testing is less about safety than about measuring how well the product works. The goal is to improve survival rates for severe trauma patients by 10 percent or more, Dr. Luchette said.
The unusually public process for launching the study is Cincinnati's answer to new regulations from the U.S. Food and Drug Administration (FDA) that took effect in September.
In limited circumstances, the FDA will allow doctors to do experiments without patient consent: if the patient is unconscious and his or her life is in immediate danger, there are no relatives around to ask for consent and there are no other established treatments that have a good chance of success.
In such situations, the FDA requires researchers to seek public comment and give public notice that their institution is involved in the experiment. Researchers also are required to seek after-the-fact notification and consent from patients or their families as soon as possible.
Once advertising begins, the public will have three weeks to send comments. The replies will not be treated as votes - there is no set number of positive or negative comments that will decide the question.
Instead, the comments will go to UC's Institutional Review Board, which must approve all medical experiments involving the university. Officials say the public comments will have a powerful influence on the board's decision.
"This is the first time investigators have been asked to go to the community. I think it's a great idea," Dr. Luchette said.
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