University of Kentucky hospital is participating in a blood trial
LOUISVILLE -- The University of Kentucky Medical Center is participating in a clinical trial testing an experimental blood substitute and some critically injured patients may be receiving the substance without their consent.
The substance -- PolyHeme -- is compatible with all blood types. It is derived from human blood and is supposed to improve oxygen levels in people losing massive amounts of blood. Another advantage of the substance is that it has a shelf life of more than a year, compared with six weeks for blood.
Trauma surgeon Dr. Andrew Bernard, principal investigator for Kentucky's portion of the trial, said patients or family members are being asked permission whenever possible. But a goal of the trial is to gauge whether PolyHeme improves the chance of survival for severely injured trauma patients -- most of whom are unconscious or unable to communicate.
Researchers have attempted to inform potential participants about the trial at UK through an advertising and public relations campaign and community meetings. Sometimes, Bernard said, risks are necessary to advance the cause of science.
"Somebody has to do a trial. That's medical research," Bernard said. "We must continue to challenge our current practices to make people better quicker."
Medical ethicists are divided on the consent issue, while some patient advocates say it is wrong, given the unknown risks.
"It's so important to gain consent," said Vera Hassner Sharav, president of the Alliance for Human Research Protection, a patient's rights organization. "It is a personal and individual right. It's a human right that we can't waive."
Dr. David J. Doukas, chairman of family medicine and medical humanism at the University of Louisville, said some people may consider unwittingly being part of an experiment a worse indignity than the possibility of dying. Sharav suggested that PolyHeme be tested instead on patients who can give consent, such as those undergoing surgery.
But Bernard said the goal of the study is to determine if it saves lives in the absence of blood. Answering that question, he said, could potentially help millions.
UK is the only hospital in Kentucky that has joined the national trial.