Here's a current newspaper story from the American state of North Carolina, where Duke University's hospital is proposing a clinical trial of a blood substitute called Polyheme.
Friday, May 14, 2004 6:17AM EDT
Duke may try synthetic blood
Synthetic could aid in emergencies
By CATHERINE CLABBY, Staff Writer Victims of highway crashes or shootings in Durham may get injections of an experimental synthetic blood substitute this summer -- without their consent.
The treatment would be part of a clinical trial proposed by Duke Hospital of a blood substitute called PolyHeme. Some ethicists denounce drug testing where people can't give approval. But the Federal Drug Administration allows it for promising treatments, such as this one, when no other option exists.
"We're allowed to do this in cases of life-threatening situations where there is a perceived benefit," said Dr. Steven Vaslef, medical director of the Duke University trauma center and lead investigator on the clinical trial.
The treatment, if approved, could be used by ambulance crews as well as hospital staff.
Durham County emergency workers, like most throughout the country, do not carry blood in their ambulances. Blood spoils quickly, and identifying patients' blood type takes time. Instead, emergency workers inject a solution into patients' veins to replace the volume of blood lost and prevent some injury.
But those solutions cannot carry life-sustaining oxygen to patients' organs. PolyHeme, the artificial blood closest to getting FDA approval, can.
So its maker, Northfield Laboratories Inc., an Illinois biotech company, is financing the clinical trial. Treatments are expected to cost $1,000 per patient.
Duke University's Institutional Review Board and the county attorney's office must approve the planned trial and are reviewing it. The campus review board, which evaluates experiments involving people, is requiring Duke to schedule public hearings to educate residents about the plan.
Emergency medical workers, trauma surgeons and military medical workers have long waited for a synthetic blood substitute that would be practical outside hospitals, since existing blood supplies can't be used in every medical emergency.
PolyHeme is made from hemoglobin extracted from donated blood bought from the American Red Cross and Blood Centers of America. While it doesn't include blood components that require type matching, it includes the microscopic machinery needed to carry oxygen to vital organs, such as the heart and brain.
Northfield has even bigger dreams for PolyHeme. On its Web site, the company predicts that blood treatments for elective surgery may be its biggest market.
Vaslef, the Duke trauma surgeon, encountered PolyHeme when a badly injured Jehovah's Witness patient, adhering to her religious belief, refused a blood transfusion in his trauma unit. Vaslef treated her with PolyHeme, and he is convinced it saved her life.
Transfusions from banked blood carry risk, not only of dangerous viruses. Research has shown that patients who receive multiple transfusions in trauma units are more likely to die from multiple organ failure, Vaslef said. No one knows why.
In this trial, up to six units of the blood substitute would be given to some patients treated by ambulances staffed by Durham Emergency Medical Services and later at Duke Hospital. Patients could receive the synthetic blood for up to 12 hours, but doctors at any point can administer blood if they prefer.
To participate, patients must be at least 18 years old, critically injured, losing a large amount of blood and in shock.
Durham emergency medical workers, who treat about a dozen gunshot victims a month, along with people who are stabbed or hurt in car crashes, encounter those patients regularly. They see promise in this trial.
"This is something that could make a difference in someone's life," said Kevin Wilson, education director of Durham County Emergency Medical Services.
(Staff researcher Brooke Cain contributed to this report.)