Scientists Will Test Extreme Hypothermia on Pittsburgh Trauma Patients

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Tisherman and his colleagues said they have tested this deep-chilling method on pigs and dogs, with considerable success. Now, they'll have to see if it works on human trauma patients. To do that, they'll start trying it out early next year on the residents of Pittsburgh who come to the hospital with traumatic injuries, a fact that raises a number of thorny ethical issues.

Patients who are bleeding to death are in no state to give the informed consent usually required in clinical trials that test new treatments. There isn't even time to get the consent from a family member. But new treatments designed for patients in such a state can never be used if they aren't tested first.

"The only way you learn about promising techniques and whether they will work or not is by trying them out," said Rosamond Rhodes, director of bioethics education at the Mount Sinai School of Medicine.

Rhodes said government regulators say new treatments can be tested without informed consent if studies meet three requirements: the condition being treated is life-threatening, the patient would benefit considerably from treatment, and getting the patient's informed consent is impossible. The extreme hypothermia study meets those criteria, Rhodes said.

On Tuesday, Tisherman and his colleagues started a campaign to educate Pittsburgh residents about the deep-chilling process. The University of Pittsburgh put ads on city buses, created a website, and posted a video on YouTube, giving residents more information about the treatment. They will also hold town hall meetings in early December, where patients who are concerned about the risks of the procedure can opt out.

Children, pregnant women, and people over age 65 who wind up in the trauma unit will be automatically ineligible for deep chilling. So will patients who have blunt trauma from falls or car accidents. But other residents who want to opt out will be given a bracelet to wear as an indication to trauma nurses and doctors not to start the chilling process.

Tisherman said the University of Pittsburgh trauma team will use deep-chilling procedure on only about 10 patients initially.

If the treatment works, emergency physicians say it will be a big step forward in treating trauma patients.

"If you have massive trauma and cardiac arrest, your chances of survival are extremely low," said Dr. Arie Blitz, director of cardiac transplant surgery at University Hospitals in Cleveland. "Any efforts to improve these outcomes would be a great contribution to both civilian and wartime traumatic scenarios."

Dr. Art Caplan, a bioethicist at the University of Pennsylvania, said the new procedure is promising and should be tested, but it raises a number of inescapable ethical issues, including the possibility of neurological damage.

"Yes, we saved their life, but you could leave some damaged, some severely disabled," Caplan said. "Who's going to pay the cost of caring for such people?"

Blitz noted that any patient who goes into cardiac arrest runs the risk of winding up with brain damage.

"You have to remember the situation. These trauma patients have a 93 percent chance of dying. Despite all the advances in trauma care, we've never been able to improve that," Blitz said. "I think the risks are very worth it."

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