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Posted

They kept it on the downlow pretty well as far as media went. The individual in question that I know was working in the ER at the time of occurrence... basically, the patient was OD'd, got nasally intubated and they used Narcan to restore responsiveness and thought it'd be hilarious to have the patient walk in, bagging self... they were extubated post-haste and the medics in question were disciplined (but I don't really know about fired.) The story spread amongst the EMS folks of CO... but I know someone claiming to have borne direct witness, and have no reason to mistrust them.

Denver Health is also famous for the "backboard sandwich o'death"- combative patient? Smush 'em between two backboards! Except that one stopped breathing. Those guys DID get fired from what I understand.

I didn't realize there was goofiness with the Polyheme study- I never did hear any much more about it other than Denver Health was participating in the trial... have to look that one up!

Wendy

RN-ADN

CO EMT-B

  • 2 weeks later...
Posted

What did happen with that Christopher?

(Maybe you can paraphrase and save me hours of waiting for pages to download to search?)

Posted

In a nut shell, the PolyHeme study was discontinued early due to poor outcomes associated with the PolyHeme groups. Unfortunately, the ethics revolving around how people were actually enrolled and allowed to opt out of the study were a bit...dubious. Nothing overtly illegal, but ethically dubious nonetheless.

  • Like 1
Posted

http://www.denverpost.com/news/ci_4134247

A controversial study testing a blood substitute in seriously injured patients at 32 sites - including Denver Health Medical Center - has ended.

The blood substitute - PolyHeme - was used on patients who had suffered blunt trauma and had loss of blood and low blood pressure, according to Dr. Ernest Moore, Denver Health's chief of surgery and trauma services.

Denver Health enrolled 120 patients since the study's start in 2003, said Moore, who has worked for more than a decade on PolyHeme's development.

Northfield Laboratories Inc., the maker of PolyHeme, said the study reached its goal of 720 participants.

Dr. Steven Gould, Northfield's chief executive, said the study results may be ready by this fall.

PolyHeme is made by extracting hemoglobin from human red-blood cells, then filtering, processing and combining it with an electrolyte solution.

Moore said that while the FDA could approve PolyHeme for emergency use based on the current study results, further study may be needed before the product can be approved for other applications.

The research elicited testimonials from patients - including the daughter of singer Hank Williams Jr. - who said they would have bled to death without PolyHeme.

It also drew criticism from some in the medical community, who called it unethical.

The controversy peaked four weeks ago when ABC's "20/20" aired a segment on the research.

This spring, three medical ethics professors signed an open letter to boards at hospitals in the study saying the research "fails to meet ethical and regulatory standards."

The three - Robert Nelson of the University of Pennsylvania School of Medicine; Nancy King, a professor at the University of North Carolina School of Medicine; and Ken Kipnis, a medical ethics professor at the University of Hawaii - asked the hospitals to sharply alter or end the research.

In the study, critically injured patients were given either PolyHeme, or the current standard treatment, saline solution, by paramedics or other emergency personnel.

Since eligible patients were hemorrhaging, in shock or unconscious - and not capable of giving consent- the researchers received FDA permission to enroll participants in the study without their prior consent.

Ambulances don't carry whole blood because it must be kept refrigerated and it is difficult to determine a patient's blood type at an accident or injury scene.

Objections focused mainly on the fact that patients also got a blood substitute after arriving at the hospital, where whole blood was available.

"We make efforts to contact patients' families instantly," Moore said. "At Denver Health, virtually every family was contacted within 12 hours of arrival" at the hospital.

There are about a half-dozen synthetic blood and blood-substitute products in various stages of development and testing.

Staff writer Karen Augé can be reached at 303- 820-1733 or kauge@denverpost.com.

Posted

You know, kind of a funny story on this. This was one of the few things that caught my interest during a time when I was all excited about investing...

I'd just gotten back from Afg, or wasn't back yet, I can't remember, but started thinking of the massive market such a product would have just with the military. Researched the bejeezus out of it...Man, they were building new factories for it's production after completion of clinic trials!

I called everyone I knew, "Oh my God! You need to buy this stuff!! Trust me on this!!" Being the poorest member of the family no one listened of course...I was so disappointed in them all...then read that the trials had been discontinued...I immediately though, "Oh man...I think I don't know all that I need to know to get rich in the investement world..."

Whew. Good thing I didn't have any money to invest...

Posted

I know several folks who invested in stock and lost their collective assets because of early reports on the studies on polyheme and biopure.

Granted it will be a golden cash cow for the researchers that do finally create a product to replace whole blood.

Posted

Yeah, man, it was so exciting! Trials going awesome, a new factory built for production, 50 person staff in place for when trials are completed, and Pfffftttt....Dead.

Whoever does figure it out, yeah man, they will be sipping margueritas on a beach somewhere...

  • 2 weeks later...
  • 2 months later...
Posted

I know some of these posts are older, but wanted a moment to clarify some factual inaccuracies contained in this thread.

1) Denver Paramedics ran 100,000 calls last year, more than every other EMS agency in the state combined. Its medics are hardworking, dedicated, ethical people. The incident of the guy walking into the ED bagging himself has been told and re-told for 20 years. Although I have talked to many people who have claimed to have "been there" when it happened, none of those people can provide many other relevant details (who was the paramedic that did that, whether the patient was male or female, etc).

2) Denver Paramedics had nothing to do the research design, IRB approval, etc for the PolyHeme study. Instead, it served as a research site because of the high volume of trauma we see, the ability for our paramedics to manage both a sick trauma patient AND follow a research protocol, and that all Level I trauma returns to a single facility. Any suggestion that there were ethical lapses on the part of the paramedics themselves is both factually inaccurate and potentially slanderous.

3) Ketamine was added to our formulary on 1 July, not for pain management. But to manage a narrow range of patients who are presenting with excited delirium.

4) Denver Paramedics regularly hire. Many of our new people are coming from within our basic ranks and from our paramedic school. It makes sense to hire people you already know. And the paramedic students have essentially gone through a 500 hour interview, as that is the amount of field time they get with use by the time they graduate from school. However, the division does hire a wide range of providers from outside the system. Obviously, those with more work experience have a better chance of getting hired.

I am not part of admin, but a paramedic field instructor with almost 30 years in and having worked in several systems in several states. People move from across the country to work here. If you have specific questions you would like to ask from someone who is on the inside -and not from people who are posting second hand information- please email me directly: dunntm(at)yahoo(dot)com. Or, contact our HR department.

Good luck to you.

Thom Dunn

Posted

Mr. Dunn- glad to see someone who works there posting!

I have a couple good friends who work there currently (and a couple friends who used to work there back in the hairy old days.)

Please don't take offense at this thread- one would hope that anyone seriously seeking info about an agency would pursue multiple avenues of research and treat an open forum thread like this one for exactly what it is.... scuttlebutt and second hand perspective. Valuable to some degree, but not an overall accurate picture of what it'd be like to be employed by that agency...

I don't think anyone was intentionally casting aspersions with regard to the PolyHeme study; it simply is known that the study failed after it showed so much promise, and Denver Health was the venue in which it failed. Unfortunate association, but I don't think anyone is saying DH is why it failed... it's like being the hospital where the patient caught fire from the chlorhexidine scrub and electrical implements being used. Craptastic, now that's what people associate with our place for a while...

The really good agencies to work for, both prehospital and in-hospital, are very hard to break into from the outside. While they may always be hiring, it takes persistence and sometimes sheer luck to break through that wall. It's definitely easier from the inside as a student. Hence why some people give up; they figure it's unattainable to work for XYZ hospital or EMS company... folks who are willing to repeatedly apply while working elsewhere to gain experience are who succeed. Colorado is this awesome niche for healthcare IMHO, and that makes it even more difficult (especially with a high saturation of educational programs along the Front Range) to crack that nut and get the gig you want.

Wendy

CO EMT-B

RN-ADN

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