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Chicago Hospital Joins Fake Blood Study

Posted on: Thursday, 4 November 2004, 15:00 CST

CHICAGO - Loyola University Medical Center has joined a nationwide study of a potentially revolutionary artificial blood product that's being tested in trauma patients without prior consent, authorities said Wednesday.

Doctors say the product called Polyheme could transform trauma care if it saves lives by quickly replacing blood loss at the scene or en route to the hospital.

After months of preparation, including efforts to give local residents a chance to refuse participation, Loyola began the study Monday by equipping its medical helicopter with Polyheme. Hospital spokesman Stephen Davidow said in coming weeks Polyheme will be used in as many as six ambulances in three Chicago suburbs.

Because trauma patients often are unconscious or in shock, they are unable to give the consent required for experimental treatment. As a result, the Polyheme researchers are being allowed to bypass the consent rules under a 1996 federal exemption that applies to emergency, potentially lifesaving research.

Polyheme's maker, Northfield Laboratories, is the second Illinois company to test a blood substitute without obtaining prior patient consent. The first, Baxter Laboratories, halted research on its own artificial blood in 1998 after the deaths of more than 20 patients who received the product.

While there's evidence that Polyheme can be safely used in hospital patients, the study is "bringing it closer to the time of insult and injury by testing it in the field," said co-researcher Dr. Mark Cichon, director of Loyola's emergency medical services. He said there hasn't been a similar advance since World War I research on saline fluids that are now standard procedure for trauma victims.

"If the study proves that this is a safe product, it will in some ways revolutionize what we are doing for trauma patients," Cichon said.

Ambulances do not carry human blood, which has a short shelf life. Instead, patients get an intravenous saline solution to restore fluid volume and blood pressure. But unlike blood, the fluid does not contain tissue-nourishing oxygen, so patients risk organ damage.

Polyheme has that blood-like ability and is made by extracting oxygen-carrying hemoglobin from human red blood cells. It can be used in patients with any blood type and lasts longer than blood.

Loyola hopes to test Polyheme on about 20 patients, and results will be compared with 20 patients given saline fluids, Cichon said.

Davidow said as of Wednesday, no patients had been tested because none had met the study qualifications.

Criteria include severe blood loss, and participants must be older than 18. People excluded include pregnant women, people with severe brain injuries and those who require cardiopulmonary resuscitation to maintain their heartbeat.

More than 700 patients nationwide are expected to participate in Polyheme research at more than 20 centers. Loyola is the 16th center to join and the only hospital in Illinois involved, according to a Northfield spokesperson.

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On the Net:

Loyola: http://www.luhs.org/bloodsubstitute

Polyheme: http://www.northfieldlabs.com/polyheme.htm

Source: Associated Press/AP Online

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