An Experiment in Saving Lives

The Washington Post ^ | March 23, 2004 | Rob Stein

[neverdem]

Emergency Patients Unwittingly Get Artificial Blood

Paramedics in five U.S. cities have started infusing experimental artificial blood into victims of car crashes, shootings and other life-threatening emergencies without first getting their consent, as most research projects require.

Ambulances and medical helicopters racing to bring hemorrhaging patients to more than a dozen other hospitals around the country, including possibly two in Virginia, will eventually join the test of the synthetic oxygen-carrying liquid, called PolyHeme.

Supporters say the study is the only means to prove that the pouches of red fluid offer one of the longest-sought tools in medicine -- a way to prevent people from bleeding to death before they get to the emergency room.

Critics, however, say the work is unnecessary and violates a fundamental ethical tenet of scientific research that protects people from becoming medical guinea pigs against their wishes.

[neverdem]

I have no trouble without informed consent from unconscious trauma patients. I think these ethicists are obsessing in the extreme.

[Atlas Sneezed]

And if the death rate is higher than it needs to be, when plenty of proper whole blood was available?

[neverdem]

PING

[neverdem]

And if the death rate is higher than it needs to be, when plenty of proper whole blood was available?

Did you read the whole story? I'll be back later.

[Britton J Wingfield]

They wouldn't get blood anyway, they'd get saline.

Assuming the product is not actually harmful, the rate can only go down or stay the same. Safety testing is already done, btw.

[MineralMan]

"And if the death rate is higher than it needs to be, when plenty of proper whole blood was available?"

---

Whole blood is not available at accident scenes, nor in ambulances. In the case of massive loss of blood, immediate action is required.

Take the case of the accident victim who is trapped in a vehicle and must wait while emergency workers use hydraulic equipment to free the victim.

If bleeding is ongoing, this treatment might well save a life. I can't see it being used except in extreme cases.

For me, if I woke up in the hospital after such an accident, I'd be pretty grateful.

In my own community, we had a case where a man had a chainsaw accident, severing his femoral artery. The paramedics arrived in time to stop the bleeding, and the man was alive when they began transport to the hospital. He died enroute. Had this technology been available to the paramedics, he likely would have lived.

Sorry, but your whole blood response doesn't address the problem.

[Doctor Stochastic]

They used to do this with flor-inert (also used for cooling Cray-2 computers). It was used by various Christian fundamentalist groups which didn't approve of transfusions. It kept the vessels full and would help prevent shock.

[The Great RJ]

Having been a paramedic for 15+ years, I know of several situations where this blood substitute would have been life saving. I remember once accident where the victim had serious internal bleeding and couldn't be extricated for some time. We poured liters of LR(lactated Ringer's Solution) in with large bore IV's to keep her blood pressure as high as we could during extrication and evacuation to the Trauma Center, but while we could partially compensate for the volume loss, there were not enough red blood cells remaining in her circulation to carry oxygen to her brain and other tissues. A young wife and mother died that day.

[Atlas Sneezed]

They wouldn't get blood anyway, they'd get saline.

---

I stand corrected. If it is a proposed improvement to existing alternatives, then there should be no reason to object.

[farmfriend]

short list.

[E.G.C.]

BTTT!!!!!

[BykrBayb]

Safety testing is already done, btw.

According to this article, and another one I read a few weeks ago, this is the an experiment.

Paramedics in five U.S. cities have started infusing experimental artificial blood into victims of car crashes, shootings and other life-threatening emergencies without first getting their consent, as most research projects require.

Ambulances and medical helicopters racing to bring hemorrhaging patients to more than a dozen other hospitals around the country, including possibly two in Virginia, will eventually join the test of the synthetic oxygen-carrying liquid, called PolyHeme.

Supporters say the study is the only means to prove that the pouches of red fluid offer one of the longest-sought tools in medicine

Critics, however, say the work is unnecessary and violates a fundamental ethical tenet of scientific research that protects people from becoming medical guinea pigs against their wishes.

"It's hard to think of any justification for ever doing research on any human subjects without their consent," said George Annas, a medical ethicist at Boston University. "That's a bedrock principle of human-subject research."

The case illustrates the collision of goals that occurs whenever researchers try to come up with new ways to save people in emergencies, when the most seriously injured are often unconscious or in shock and therefore unable to consent to an experimental procedure.

"Trials like this are unbelievably important," said Kenneth Kipnis, an ethicist at the University of Hawaii. "There is a lot of good that can come of studies like this."

The PolyHeme study is the latest of about 15 similar experiments that have been approved since 1996, when the Food and Drug Administration created a special category of research that eliminated the need for patient consent in specified circumstances so scientists could develop desperately needed emergency treatments.

"This study is exciting..."

Northfield is confident PolyHeme is safe and hopes to demonstrate that and its ability to save lives in the new study, which began in December and will involve 720 adults in shock from extensive blood loss. Half will get PolyHeme, and half will get saline. (Pregnant women and those with head injuries will be excluded.)

A family member will be contacted as soon as possible, however, to see if the patient may continue in the study.

Testing has begun in Houston; Denver; Memphis; Allentown, Pa.; and Newark, Del. Nearly 20 more hospitals will eventually join the study, and many are actively considering signing on, including Sentara Hospital in Norfolk and Virginia Commonwealth University Hospital in Richmond.

Before a hospital joins the study, it must get approval from its internal review board. That entails gauging each community's reaction to the study...

So far no center has decided against joining the study, Gould said.

But Nancy M.P. King, who teaches medical and research ethics at the University of North Carolina School of Medicine, has several reservations about the study...

Boston University's Annas argues the study could be designed to make consent possible...

...not if they don't want to be in the study...

...But in the cases of promising experimental emergency treatments such as PolyHeme...

"It really is the only way that we or anyone else believes this study could be done."

I don't think there's any question. This is an experiment.

[neverdem]

I finally signed up for Washington Post, just so I could read this.

And I thought I was a really bad procrastinator.

Didn't Dr. Mengele use the same argument?

I have no idea. Do you have any references? I'm not aware of Mengele doing any work in the service of medicine, just murdering innocent people by vivesection, injecting with toxic chemicals, etc.

In this test they already have results that there's a good probability patients will benefit and that lives will be saved. God forbid, but if you were unconscious and bleeding to death, wouldn't you want them to try it on you if there wasn't blood available?

If you were unconscious and got to the hospital fast enough, you would be transfused with O negative blood, the universal donor, without your consent if they had to emergently transfuse blood, even though there's still a small chance of a transfusion reaction, IIRC. I think it takes about 45 - 60 minutes to type and cross-match blood before a person can be transfused with blood that matches that person's blood type.

[neverdem]

BTW, how did you retrieve this thread?

Call it a study, experiment, whatever. This is the closest way of doing what's called a double blind, placebo controlled test, the gold standard in medicine, in a surgical specialty, as opposed to a medical one in which neither the patient nor the dispenser of the medicine knows whether the patient is getting a real medicine or a sugar pill.

Most surgical procedures have never been adopted on the basis of double blind, placebo controlled studies. Surgeons adopt procedures because that's what they were taught. Many orthopedic surgeons have been doing arthroscopic procedures on patients with osteoarthritis of the knees for years. It was just recently announced that patients who had the procedure did no better than patients who had a sham procedure in which those patients had the same external incisions, but little else and no cutting or scraping within the joint.

[BykrBayb]

BTW, how did you retrieve this thread?

I was looking at the Delaware threads.

[neverdem]

Doctors performed a series of experiments on her, without her knowledge or consent. They killed her.

Where did this happen, and how do you know they killed her, and that it wasn't the diabetes that killed her, if I may ask?

[armymarinemom]

PolyHeme website. I read over the website only briefly. This could be great in trauma rooms. Red Tag blood isn't without risks. I've seen a lot of trauma cases and vascular emergencies with this would be very helpful.

[neverdem]

Thanks for the link.