Ethicists Blast Study Testing Fake Blood

[FVZA_Colonel]

http://news.yahoo.com/s/ap/20060302/ap_on_he_me/blood_substitute



Ethicists Blast Study Testing Fake Blood
By LINDSEY TANNER, AP Medical Writer

CHICAGO - Imagine being in a car crash, lying unconscious and bleeding in an ambulance. With no blood on board, paramedics give you an experimental substitute, but even at the hospital, you get fake blood for several hours before doctors try the real thing.

Medical ethicists say a study that is doing just that on hundreds of trauma patients without their consent should be halted.

It's a renewed attack on research that began in 2004 after Northfield Laboratories got federal approval for its study of the blood substitute Polyheme.

Debate was reignited by a Wall Street Journal story last week that suggested the company tried to hide some crucial details about another blood substitute study back in 2000. The Journal reported that 10 heart surgery patients in that Polyheme experiment had heart attacks, while other patients given real blood did not.

[AngryAmish]

1. This is a tough issue

There seems to be extreme ethical problems getting informed consent. But artificial blood could be a great boon to mankind.

Why do they have to keep giving the fake blood to folks when they get to the hospital?

[Warpy]

2. ER is a fantasy

and often there is a wait for blood to arrive from the blood bank and to be checked in and for plasma and/or platelets to be thawed, all of which take time. There are multiple checks to make sure a Type A patient isn't getting Type B blood the blood bank sent by mistake. You can't just yell "Gimme six units 0-neg!" and have it hung immediately on preflushed tubing.

Let's see, you can have salt water that doesn't carry oxygen or nutrients, or you can have an FDA sanctioned but not fully approved substitute that does. The former will support your blood pressure, but that's all.

Personally, I'd want the Polyheme. It beats the hell out of multimple organ system damage while the real blood is on its way to a small clinic in the boonies. As soon as the real blood gets there, though, the Polyheme should be discontinued.

However, as a general rule, informed consent should be obtained when using any sort of "experimental" drug undergoing large scale clinical trials. If you're dealing with a critically injured patient, though, that is not going to happen.

I'd like to know a little more about this stuff, like whether or not the patients were conscious, how large the hospitals/clinics were and whether or not they had on site blood banks. These things all make a difference, as does whether or not money was changing hands whenever this stuff was being tested and how big a sample produced those heart attack results.

[China_cat]

3. IF they have your type at all

there's the wait for all that. Charleston, SC blood banks usually have only 1 pint of B- blood available and none at all of AB-. I'm B-. If I need blood in an emergency, even at one of the big hospitals here, I'm in deep shit. (For scheduled surgery they will try to have 6 units on hand but it usually means banking your own.)

[Warpy]

4. In an emergency, 0-neg is the universal donor type

and can be administered to people of all blood types.

I'm B+, and it's not much better for me.

[DrBloodmoney]

8. You're not screwed

unless they don't have o-neg on hand.

[Wilber_Stool]

5. Here's a quick google

Kind of like a FAQ:

http://www.denverhealth.org/TraumaCenter/Polyheme.aspx

It's not dated so take it with a grain of salt. Could be more info available now.

[The Backlash Cometh]

6. Jeez. Not only are our jobs being outsourced, but now we've become

Mengele's guinea pigs.

[Teaser]

7. I assume its made it past the animal testing phase?

nt

[DrBloodmoney]

9. This is what I do for a living

I'm a pathologist. We run blood banks (among other things). The purpose of Polyheme is twofold: 1. provide volume replacement in trauma situations where the patients have lost blood volume (ie. they are in danger of shock), and 2. provide oxygen-carrying capacity (ie. the same as hemoglobin does).

If this can pass FDA trials it will be a huge boon and save a lot of lives. Currently patients will receive fluid replacement in the field (administered by paramedics) in the form of saline or glucose/water. This provides fluid replacement to maintain blood pressure and keep vital organs perfused while en route to an ER. This does not carry oxygen to your vital organs.

Paramedics do not carry blood in ambulances. It is just not feasible. Human donor blood is very, very dangerous stuff in the wrong hands. The purpose of Polyheme is to be carried on ambulances for paramedics to administer to patients who have significant blood loss (ie. the oxygen carrying capacity of their blood is decreased). It has potential to be very life-saving in the future.

This would be a stop-gap solution until the patient reaches an ER, where they have access to blood bank services.

The problem is obtaining consent from patients for the trial. Patients who would be considered for the trial typically aren't in any condition to give informed consent (ie. significant blood loss/shock). Therefore, the ethical concerns are valid.

also this is in phase III clinical trials, well past the animal testing phase.

[Mz Pip]

10. Thanks for the info

And welcome to DU :hi:

Personally, if it were a choice between dying and getting Polyheme I'd take the Polyheme, and hope for the best.

Mz Pip :dem: