Hospitals aim to test substitute for blood
Product that may raise chances for survival to be tested on trauma victims if community approves.
By Diana Penner
diana.penner@indystar.com
January 21, 2004
Two Indianapolis hospitals will announce plans today to test a blood substitute on ambulance patients in the hope that it could someday save lives on battlefields and city streets.
With community approval, Wishard Memorial and Methodist hospitals would be among 20 trauma centers nationwide testing the product, which would be used instead of the saline solution now given to ambulance patients with massive blood loss.
Saline solution helps maintain the volume of fluid in veins while ambulances whisk patients to a hospital, but it can't transport oxygen, increasing the risk of brain damage. The new product can deliver oxygen to tissues.
"It'll be exciting," said Dr. Michael Olinger, medical director of Wishard Ambulance Service.
The blood substitute, PolyHeme, is made from hemoglobin extracted from red blood that no longer can be used for transfusions or other procedures. The hemoglobin is mixed with a kind of saline solution, allowing it to transport oxygen and maintain fluid volume. Ambulances don't carry blood because it is delicate and could go bad.
"The significance is that we have not in the past had a product able to carry oxygen," said Dr. Ed Bartkus, director of emergency medical services at Methodist Hospital.
If PolyHeme works, it will be a critical addition in war situations and in rural areas where patients face long transports or delays getting to fully equipped hospital trauma centers.
The maker of PolyHeme, Northfield Laboratories in Evanston, Ill., received approval in December from the U.S. Food and Drug Administration to conduct this phase of the trial on 720 patients at 20 trauma centers across the country. Because the treatment is specifically aimed at emergency situations where patients are critically injured, and possibly unconscious or incoherent, participants will not be asked for consent before they are given PolyHeme.
The FDA grants special waivers from the consent requirement for emergency treatment trials -- depending on community approval. Before the trial could begin in Indianapolis, residents will be given a chance to ask questions and offer comments at a series of public meetings.
That's important, said Dr. David Orentlicher, co-director for the Center for Law and Health at Indiana University School of Law and a faculty member of IU's Center for Bioethics.
Generally, participants in clinical trials must sign up after being informed of the risks and benefits. But in emergency situations, where basic treatment is administered without consent, it's often not possible to ask for approval before trying out a new medication or other product, he said.
Key to avoiding abuses or ethical problems in those situations is ensuring that potential benefits outweigh risks, trial participants are among those who could benefit down the road and communities are given as much information as possible, he said.
In Indianapolis, Methodist and Wishard have analyzed data on trauma victims and plan to target use of PolyHeme primarily in Center Township areas that post the highest numbers of trauma victims. Those areas also have a concentration of poor people.
"This might be one of those cases where it's actually going to be good for poor people" to participate in a clinical investigation, Wishard's Olinger said.
Wishard ambulance crews, who transport patients to both hospitals, are eager to test the product, said Chuck Ford, director of emergency response at Wishard.
"This is a product that, if borne out, will give trauma patients much more survivability," he said.
Children and pregnant women will not be part of the trial. As many as 70 or 80 Indianapolis patients could be included in the investigation, which could take about a year.
The data then must be analyzed, but Bartkus said he's optimistic and has no qualms about PolyHeme.
"Not a bit," he said. "Having looked at the initial data, I'm really jazzed about it."
Call Star reporter Diana Penner at 1-317-444-6249.
Public meetings scheduled
Wishard and Methodist hospitals must have public meetings to allow citizens to ask questions and voice support or objections to use of the blood substitute PolyHeme.
Several of the meetings have been scheduled, including:
• 7 p.m. Feb. 3, Christian Park Community Team, 4626 Wentworth Blvd.
• 7:30 p.m. Feb. 10, St. Joseph Historic Neighborhood Association, 947 N. Pennsylvania St.
• 6:30 p.m. Feb. 16, Redevelopment Revitalization of the Southside CDC, 2618 Bethel Ave.
• 7 p.m. Feb. 16, Fountain Area Community Team, 1150 S. Shelby St.
• 6:30 p.m. Feb. 19, Emerson Heights Community Organization, 10th Street and Wallace Avenue.
• 6 p.m. Feb. 26, Southeast Community Organization, 1733 Spann Ave.
More meetings are being scheduled.
To learn more
For information about the clinical trial, call toll-free to 1-866-790-0998. Additional information will be available at the Web sites of both hospitals:
www.clarian.org and
www.wishard.edu.
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