Polyheme: Ethicists want fake blood study stopped

[Jon]

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Polyheme is part of a story in USA Today. Hank Williams Jr.'s daughter's rights were abused when a lifeflight crew unwittingly made her a guinea pig and infused her with that Polyheme stuff.



http://www.usatoday.com/news/health/2006-06-13-traumas-trials_x.htm?POE=NEWISVA

I dissagree with how you put it.

From what it sounds like, her life was SAVED. The waived-consent trial is VERY important. Polyheme needs to work in trauma situations, and a waived-consent trial is the only real way to test it how it will be used.

When I saw how you put it, I thought this would be a bad article, but it is another well-written article by Bob Davis, Americas' EMS newspaper writer.

Jon

 

[Jon]

I dissagree with how you put it.

From what it sounds like, her life was SAVED. The waived-consent trial is VERY important. Polyheme needs to work in trauma situations, and a waived-consent trial is the only real way to test it how it will be used.

When I saw how you put it, I thought this would be a bad article, but it is another well-written article by Bob Davis, Americas' EMS newspaper writer.

Jon

This has been discussed - it is each persons' choice, and there is a way to "opt out" of the study. BUT - the Jehovia's Wittnesses seem like the idea of Polyheme.

 

[Guardian]

My two cents, where i work, we are participating in the polyheme trial. Do i think it's a promising step forward in medicine? Yes. Do I want polyheme used on me or my family in place of real blood during an emergency? No.

 

[ffemt8978]

My two cents, where i work, we are participating in the polyheme trial. Do i think it's a promising step forward in medicine? Yes. Do I want polyheme used on me or my family in place of real blood during an emergency? No.

Care to elaborate this a little more, especially why you wouldn't want it used on you or your family?

 

[gradygirl]

Would I rather have blood products than an HBOC? Sure, absolutely.

If I were an unconscious trauma pt. bleeding out in desperate need of blood volume who literally doesn't have the time to have blood cross typed and infused, would I care if I were given PolyHeme? Absolutely not.

Now, this is from a well informed person who is not having to worry about what I may or may not receive if I were to get into an accident and need blood. But, being a well informed person, I know that what is the most important thing in this whole PolyHeme debate is whether or not it will be passed by the FDA so we responders have one more tool by which we can try to stabilize our trauma pts. And, while I don't approve of the way Northfield is handling the testing, I will not say anything negative about PolyHeme until, god forbid, someone has a negative interaction with the product.

 

[Guardian]

I'm not an expert on polyheme.........now that i've said that, I am not convinced polyheme works as well as real blood. I'm concerned that i won't get real blood fast enough at hospital if i'm enrolled into polyheme trial. Polyheme is a good step forward and I think it has great potential for pre-hospital use ("fake" blood better that saline) but when i arrive at the hospital, I want real blood and i want it fast!

 

[gradygirl]

Alright, I am putting on the table the process through which a trial pt. goes.

In the trial areas, including somewhere between 25-30 Level 1 trauma centers across the U.S., 720 unconscious trauma pts. are to be enrolled into the trials. Ideally, the trial areas' residents should have been properly educated about the trial and given the option to opt-out of the trial by wearing a special bracelet indicating such wishes. No conscious pts. are given PolyHeme in the trial.

Treatment with PolyHeme begins on scene, is continued on the ambulance, and then is carried on in the hospital for up to 12 hours or 6 units while in the hospital.

This trial is being compared to the use of saline in the field and blood products in the hospital. AGAIN, treatment with PolyHeme is discontinued and blood products are used after 12 hours or 6 units. The trial endpoint measures the survival rate of trauma patients at 30 days.

This trial, again though violating a pt.'s right to choice, strictly adheres to the FDA's Title 21 Chapter 1 Section 50.24 Protection of Human Subjects guidelines.

 

[Guardian]

discontinued after 12 hours, that's a long time when you're in shock

 

[gradygirl]

That's what the PolyHeme treats. It's chemically engineered from real human hemoglobin to carry oxygen and replaces blood volume at the same time. Like I said in my first post, one pt. essentially bled out twice, but lived and was only given PolyHeme. As of yet, I don't know of any deaths related to PolyHeme use (or rather, a lack of blood product use). As soon as I hear of a 100% proven case that a pt. died because they received PolyHeme instead of blood products, I will promptly bight my tongue.

Also, PolyHeme has been in trials for a very, very long time. The fact that it has reached a Phase III FDA trial means that, if it does, indeed, pass, it could be available to the emergency medical system as early as 2007. No other HBOC has made it this far.

If the prior track record says anything about this product, it will be in use in a relatively short period of time.

 

[Guardian]

tcert1987, it you had two pts in exactly the same condition (shock), and one was given polyheme while the other blood, which one do you think would have the better chance for survival?..........the truth is no one knows this, thats one of the questions phase 3 is trying to answer. My point is this, i would rather be given the one that is sure to work, blood.

 

[gradygirl]

I absolutely agree with you. As I said, I would much rather receive blood products than an experimental HBOC. My argument is just that PolyHeme is an incredible tool that we may be able to use in the future, but unfortunately, invasive human tests must be carried out to make sure that it's not going to kill anyone if it is passed. To be honest, I don't agree with Northfield that it must be used up to 12 hours after the accident, I think it should strictly be used in the field on an ambulance as a better volume expander than saline. I am simply trying to lay out the hard facts about what PolyHeme is and how the trial must work to deflate some of the misguided information posted.

 

[gradygirl]

I am now getting off of my soap box.

*Steps down.*

 

[Guardian]

I can't get off my soap box, it's just too high

 

[krj00]

This is why Northfield Labs AND the FDA agreed to the 12 hours post arrival at hospital (via Special Protocol Agreement). In my opinion.

Polyheme may actually be better than blood.

http://www.bioethics.net/journal/j_articles.php?aid=998


Critics argue that, despite acknowledged limitations of banked blood, its general acceptance in resuscitation is prima facie evidence of its “satisfactory” nature. Once blood is available, they profess, randomization should be reserved for consenting subjects.

Is the efficacy and safety of transfused blood “proven”? Despite its widespread use and acceptance, the performance of banked blood has never been subjected to the level of scrutiny imposed on investigational new drugs. Transfusions fail to improve oxygen consumption in critically ill patients (Fernades et al. 2001). Attendant risks of transfusion reaction and transmission of infection are universally recognized. Few accept transfusion absent life-threatening anemia.

Is the transfusion of banked blood “satisfactory”? Clearly, it is an effective means of immediate resuscitation in hemorrhagic shock, but at what price? Clinical trials have demonstrated that transfusion increases the incidence of multiorgan failure (MOF) and increases mortality (Kao 2000; Johnson et al. 2001). In particular, transfusion of six or more units within the first 12 hours is the primary risk factor for MOF, independent of injury severity (Moore, Moore and Sauaia 1997). MOF is the leading cause of post-injury death, conferring a mortality of 35% and prolonging ICU stays an average of one month with mechanical ventilation and dialysis. The adverse effect on outcomes is not limited to trauma victims, but is particularly pertinent to this population because of the pathophysiology of transfusion-related injury (Corwin et al. 2004; Herbert and Fergusson 2004; Napolitano 2004; Rao et al 2004). Many thoughtful clinicians feel treatment that increases mortality and organ failure is unsatisfactory.

How could blood be bad? It’s a universal natural product that serves us well. Banked blood, however, is artificially preserved and gradually degrades with its 42-day storage, releasing from red cell membranes lipid mediators and cytokines. These factors combine with traumatized tissue in a two-step priming of neutrophils and oxygen radical production, each of which is highly correlated with development of MOF (Moore, Moore and Sauaia 1997; Johnson et al. 2001). Transfused units are necessarily the oldest in the blood bank with the highest concentration of toxins. Furthermore, trauma patients requiring massive transfusions first receive unmatched blood. Type-specific blood requires up to 20 additional minutes to deliver and fully cross-matched blood can require 45 minutes. The risk of immunologic complications and medical error increases under the pressure of emergency delivery. Blood’s failure to improve oxygen consumption in critically ill patients apparently stems from changes in red cell deformability with storage. Such rheologic changes can produce red cell entrapment, microvascular obstruction and tissue ischemia (Fernandes et al. 2001; Berezina et al. 2002).

By contrast, PolyHeme® has a long shelf life and is compatible with all blood types. The risk of viral and bacterial transmission is extremely low. Extensive pre-clinical and earlier clinical studies have shown very few adverse effects. Deleterious vasoconstrictive effects that have plagued earlier blood substitutes are noticeably absent with this product

 

[MMiz]

krj00,

What is your relationship with PolyHeme? I've noticed that you've asked similar questions and prompted similar discussions on several discussion forums.

 

[krj00]

We've been seening one another for about six years or so. Nothing serious.

 

[fm_emt]

The original link has expired. Blah. Stupid CNN.

Here's a new story about these kinds of trials & stuff:

http://www.usatoday.com/news/health/2006-06-13-traumas-trials_x.htm?POE=NEWISVA