A campaign starts today to educate Pittsburgh, Penn., residents on an experiment that could save their life in cases of extreme trauma. But there's a bit of a catch. This experiment involves trauma patients bleeding to death and an experimental technique where doctors inject ice cold fluid into the person as a means to slow down the victim's metabolism and give doctors more time to sew the patient up before he or she enters cardiac arrest.
The catch is that the law requires that patients to consent to be part of medical experiments after they're told the pros and cons. That's impossible when the person is bleeding to death. There won't even be time to seek a relative's permission.
A University of Pittsburgh Medical Center spokesperson Anita Srikameswaran said to The Blaze that once the experiment begins sometime in 2012, all residents who are critically injured and deemed candidates for what's being called "emergency preservation and resuscitation" would have the potential to receive the experimental treatment. If for any reason, a person wouldn't want this procedure to happen to them, they will have had to opt themselves out and wear a bracelet indicating this during the experimental period
What exactly does this treatment do and why would someone dying not want to try it? In short, in cases where patients bleed to death before doctors can patch them up, there is a theory that inducing hypothermia would slow the metabolism of the brain and other organs, meaning the patient could go without oxygen for longer periods and avoid brain damage.
Get cold enough and "you do OK with no blood for a while," says lead researcher Dr. Samuel Tisherman, a University of Pittsburgh critical care specialist. "We think we can buy time. We think it's better than anything else we have at the moment, and could have a significant impact in saving a bunch of patients."
The experiment funded by the Defense Department will target victims of gunshot wounds, stab wounds and similar injuries that result in such a loss of blood their hearts could stop beating. Today when that happens, a mere 7 percent of patients survive.
So why would someone want to opt out of this experiment? Dr. Arthur Caplan, a University of Pennsylvania bioethicist who is watching the research, told the Associated Press one concern is that some people might survive but with enough brain damage that they'd have preferred death. He says the "informed community" procedure designed for studies of emergency treatments cannot adequately cover that scenario.
The effort to inform the community about the study required by the Food and Drug Administration will include signs on city buses, video on YouTube, a website and two town-hall meetings next month. Residents worried about possible risks, such as brain damage, could sign a list saying they'd opt out if they ever were severely injured.
Here is the YouTube video of Tisherman explaining the experiment with a dummy simulation and explains that this type of experiment is reviewed by federal agencies and local ethics boards:
"Most people are going to say, `Yes I would like you to try and save my dad,'" says Caplan, who calls emergency preservation promising. But, he says, "we continue to ignore the 900-pound gorilla of who's going to manage the bad outcome."
Srikameswaran said that not every trauma patient coming into the hospital would be given the treatment. The correct medical team trained in the procedure would have to be on duty, and if the person had signed a list or were wearing a bracelet saying they'd opted out, they would not receive the deep chill treatment. Patients in these cases would receive the standard care. Patients who experience trauma from car accidents or falls will not be included in this study, nor will children, pregnant women or those older than 65.
Doctors have long sought to use hypothermia in medicine since discovering that cooling can slow the metabolism of the brain and other organs, meaning they can go without oxygen for longer periods. Donated organs are chilled to preserve them, for example. And people whose hearts are shocked back into beating after what's called cardiac arrest often are iced down to about 90 or 91 degrees, mild hypothermia that allows the brain to recover from damage that began in those moments between their collapse and revival.
But the CPR that buys time during more routine cardiac arrest doesn't help trauma patients who've already lost massive amounts of blood. Injuries are the nation's fifth-leading killer, and hemorrhage is one of the main reasons, says Dr. Hasan Alam of Massachusetts General Hospital, who is collaborating with the Pitt study.
Enter deep hypothermia, dropping body temperature to around 50 degrees. It has worked in dogs and pigs, animals considered a model for human trauma, in experiments over the past decade conducted by Tisherman, Alam and a few other research groups.
The animals were sedated and bled until their hearts stopped. Ice-cold fluids were flushed through the body's largest artery, deep-chilling first the brain and heart and then the rest of the body. After more than two hours in this limbo, they were sewn up, gradually warmed and put on a heart-lung machine to restart blood flow. Most survived what should have been a lethal injury and most appeared to be cognitively fine, Tisherman and Alam say.
Hypothermia is counterintuitive for trauma because the cold inhibits blood clotting, something to watch while rewarming people in the planned study. Still, humans can get that cold and fare well, says Tisherman, who is co-author of a pending patent for emergency-preservation methods. He points to rare cases of people who fall through ice and instead of drowning are rewarmed and wake up, as well as deep-chilling that happens during certain heart operations that require completely stopping blood flow for a short time.
"Nothing is magical. Everything has got its limitations," cautions Alam. He says the big question is whether deep hypothermia can help in the chaos of real-life trauma when "the blood has already been lost and you're trying to do catch-up."
The Associated Press contributed to this report.