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Archive for Wednesday, August 2, 2006

County ambulances no longer using synthetic blood

August 2, 2006

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Douglas County ambulances are no longer carrying the synthetic blood substitute, Polyheme.

The national trial that involved Douglas, Wyandotte and Leavenworth counties is complete, University of Kansas Hospital and Medical Center officials said today.

Area ambulances first stocked up on the synthetic blood manufactured by Northfield Laboratories in January as part of a clinical trial to evaluate the product's safety and efficacy for critically injured and bleeding patients. The study involved 720 patients nationwide.

The study compared the survival rate of patients receiving PolyHeme to that of patients who receive the current standard of care, which is saline solution followed, in the hospital, by donated blood, when needed.

In a released statement, Michael Moncure, the principal investigator, said study protocols prohibit The University of Kansas Hospital and Medical Center from releasing any numbers of enrollees locally.

Comments

neuropenguin 8 years, 5 months ago

Great I don't have to wear that dumb blue bracelet that I had to wrap with clear tape to keep it from tearing apart anymore.

Ragingbear 8 years, 5 months ago

The data now has to be correlated and compiled into a report and taken back for review at the FDA panel. There are stringent processes by which all medical substances of this type must go through.

Up until this point, it has only be granted permission for trial use, not for widespread use.

zzoomm 8 years, 5 months ago

The Wall Street Journal article argued the ethics of using patients who cannot consent to treatment due to their injuires and also focused on a poorly conducted trial in 1999. The WSJ did not provide full disclosure on all relevent information, such as a Phase II trial where trauma patients losing 70% or more of their blood were treated and 10 of 10 patients on saline died and 7 of 10 patients on Polyheme lived. Given this information, which would you choose.

zzoomm 8 years, 5 months ago

Perhaps a more current event involving Hank Williams daughter will add some insight. From an ethical point of view, how do you get consent if the victim is unable to respond?

http://www.theithacajournal.com/apps/pbcs.dll/article?AID=/20060622/LIFESTYLE18/606220301/1025

classclown 8 years, 5 months ago

A question about the fake blood...

Did it come in types, or was it generic "one size fits all"?

ASBESTOS 8 years, 5 months ago

ANother reason, the investors are sueing the company because it failed to reveal problems in the PHase II clinical trials.

YES it is a "one size fits all" thing.

http://biz.yahoo.com/pz/060801/103047.html

ASBESTOS 8 years, 5 months ago

That was the conclusion of the not revealed Phase II clinical trials. It was supposed to be the one size fits all, but is not a 100%.

That is what has the investors wanting to sue.

ASBESTOS 8 years, 5 months ago

ZZoomm,

HGA ALWAYS post in this manner with the annoying haha stuff.

It is truly annoying, and adds nothing to the discussins except an exclaimation point on HGA's mental stability issues.

DeeK 8 years, 5 months ago

Ok so they stopped, but does anyone know why? are they just done testing it? or was it not as good as the traditional method? & if so then by how much? am i missing somthing here?

passionatelibra 8 years, 5 months ago

It said the study is complete, so they stopped.

zzoomm 8 years, 5 months ago

Not quite sure what you are laughing about and don't know where you found your information on animal testing...but here is a quote for you.

"A new HBOC could be especially important for trauma care but few trials have focused on the most seriously injured, bleeding, coagulopathic patient, who typically requires massive transfusions. The new products generally appear safe when 36 units of the HBOC are used prior to giving allogeneic blood, but these data may not be directly comparable to the trauma situation [2, 7]. In addition, despite extensive preclinical testing in animals,"

matahari 8 years, 5 months ago

thanks for the info everyone. It's always after the fact or 'trial period' Oh the things you don't know to ask..who would have thought? I suppose that is not uniformed consent. Makes you wonder how many other things you don't think of. AND makes you wonder how many would have survived if given real blood, even if it was one person, why aren't these people who run the tests or the companies who make the stuff held liable? I know my post sounds ignorant but scary, very scary indeed. Oh, and was it cheaper than real blood? That could have been a catalyst for it's use also. Availablity and price.

ASBESTOS 8 years, 5 months ago

Here is why, the patient who is incapicitated cannot give consent to be an enrollee:

http://biz.yahoo.com/bizj/060728/1323215.html?.v=1

Inova halts enrollment in blood-substitute study

"Officials with Inova's trauma center, on the campus of Inova Fairfax Hospital, say no patients to date have received the blood substitute at their facility.

Inova officials say they believe PolyHeme is a promising product but decided to withdraw from the study after recent unfavorable media reports and community meetings where residents expressed their concerns. Inova didn't want to continue with the study until further information became available and appropriate reviews of the trial could take place.

PolyHeme was the subject of a recent investigation by the ABC News' "20/20" show. Some people are concerned because PolyHeme is given to incapacitated trauma patients who can't give their informed consent to enroll in the trial.

Northfield Labs says on its Web site that because patients eligible for the study are unlikely to provide consent due to the nature of their injuries, the trial is being conducted under federal regulations that allow clinical research in emergency settings without informed consent. The company also says the "20/20" story lacked balance.

Inova officials issued a statement saying, "We continue to stand by our initial decision to participate in research that could potentially lead to [Food and Drug Administration] approval of a blood substitute that would save countless lives.""

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