July 1, 1997
This month, Tulane researchers begin research on an experimental blood product designed to speed the treatment of trauma patients and to carry oxygen to cells and tissues more effectively than regular blood transfusions. The study will take place at Charity Hospital's Level One Trauma Center in New Orleans, one of 35 trauma units nationwide participating in the study.
Norman McSwain, professor of surgery at Tulane and associate trauma director at Charity, is principal investigator of the study.
"By the year 2030, experts predict a four-million blood-unit shortfall in transfusion availability in the United States," McSwain says. "Because of this shortfall, something has to be done to get us more blood on an emergency basis."
Baxter Healthcare Corp. has developed a product called diaspirin cross-linked hemoglobin to augment blood transfusions. The solution is purified hemoglobin--the part of the blood that carries oxygen to all parts of the body--taken from outdated blood supplies and pasteurized.
In the next 12 months, researchers will administer the Baxter solution to half of the patients who come to the trauma unit with low blood pressure and in shock from blood loss due to trauma incidents such as car accidents, falls and gunshot wounds. The other half of the patients will receive the standard trauma treatment. About 850 people are expected to participate in the study nationwide.
"I think this material is going to improve the survival rate [in trauma patients] because not only does it increase the oxygen-carrying capacity, it increases the blood pressure," McSwain says. "More importantly, it carries oxygen to parts of the body that might not otherwise get it."
Another benefit of the new product is that it works with any blood type, so physicians can administer the solution immediately without waiting for matching blood from the blood bank, he says. It also has a longer shelf-life than whole blood. McSwain says that the product may eventually reduce whole blood transfusions.
"We think this material will add to the resuscitation of trauma patients so that perhaps in the future it will not be necessary to give somebody red blood cells," he says. "But at this stage, all patients will get the exact same number of transfusions as indicated by their condition."
New rules from the U.S. Food and Drug Administration regarding emergency patients will allow researchers to waive the requirement to obtain written permission from the study participants. McSwain says they will attempt to get consent from patients or the family members before administering the solution whenever possible.
The FDA has mandated, however, that researchers inform the general public about the study before they begin. The study directors held a press conference in early June and hosted a public meeting on June 18. They are also participating in other outreach activities. Emergency personnel at Charity will choose participants randomly and expect to enroll about 30 people in the study.
McSwain says the diaspirin cross-linked hemoglobin solution has proven safe and effective in previous animal studies and clinical trials with humans. "The reason that this is such an important study is that there has not been a major change in the resuscitation of trauma patients in the last 30 years," McSwain says. "This is perhaps the most major change that has occurred."
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