What happened to PolyHeme?

[MMiz]

What was the deal with PolyHeme? They declared bankruptcy and have ceased all operations. That was an expensive 220 million dollar trial.

The drug showed no hope?

 

[Ridryder911]

Yeah, along with all of the stocks I had bought.

R/r 911

 

[LucidResq]

Don't know if you've seen these numbers...

Final PolyHeme Public Disclosure (Denver Health)

 

[Shishkabob]

Strange results--- seems as if polyheme caused more harm then it helped, mainly in the cardiac arena.

 

[LucidResq]

That's why the FDA rejected it... too many significant adverse effects and not enough clinical benefit to justify the risk.

 

[Shishkabob]

I wonder what the results would have been if they had crossmatched blood types for a 3rd control.

Like, make PolyHeme from an A+ blood sample, and put it in an A+ pt, and see the results.


(Yes, I know it's supposed to be a general supplement, but it IS science, so more info never hurts)

 

[LucidResq]

I'd be more interested in whether or not the results would have been better if the Phase III trial more closely represented what this product would have been best used for - exclusively prehospital, especially in areas with long transport times.

In the Phase III trial PolyHeme was administered prehospitally and was continued in-hospital. All of the trial sites were urban with relatively short transport times. The problem with current protocols isn't so much that whole crossmatched allogenic blood isn't working, it's that it's impossible to provide blood in certain settings, especially prehospital. Wonder if the product would have shown more promise had it been administered prehospital, and then standard crossmatched blood was given in-hospital.

 

[PapaBear434]

My buddy is an RN in the Navy, and is currently in Afghanistan basically acting as a trauma nurse and medic. According to him, they are still using PolyHeme or something like it because keeping blood viable and on hand in a desert isn't easy.

But the military is always at the forefront of these fun toys and techniques. He said he is also getting to use all sorts of coagulant agents that can temporarily seal off a gushing abdomen wound and others that he's basically sprinkled on a femoral arterial nick and watched it chemically seal shut within seconds.

But I also assume on the battlefield it's a bit different. You don't have time to properly wrap a wound with pressure bandages and move them. You just pour the stuff on and risk that the patient might move one of those clots through the body where it's not supposed to be. In addition, you know that anyone out there is likely to be in fairly good shape and not have any major medical issues. If you're going to treat a trauma patient with a new, untested material, nice strong, otherwise healthy young men in their prime are the way to go.

 

[Shishkabob]

I assume you're speaking of Quikclot, Papa? If so, the military is moving away from that last I heard.

They still want hemostatic agents, but there have been problems with some types causing an embolus.



Lucid, you bring up a good point about the other phase. In hospital, they really DO have the luxury of getting the blood type and giving the right blood, while PH we do not.

But I'm wondering if A) PolyHeme help a bit more with anemic pts, as opposed to just plain old trauma

and B ) if it'd be a better 50/50 mix with NS? Since they showed the NS control worked better, maybe mixing the goods of oxygen carrying items, WITH NS, would make a difference?




I know those scientist are smarter as a whole then me, but there are plenty of other ways they could have tested and tweaked.

 

[LucidResq]

The battlefield is another setting in which an oxygen-carrying blood substitute could show promise.

As far as hemostatic agents go, it's likely the stuff your buddy described is Celox or HemCon. It has definitely shown promise in the military, and at least one small study that I'm aware of showed benefit in a civilian EMS system.

 

[PapaBear434]

I assume you're speaking of Quikclot, Papa? If so, the military is moving away from that last I heard.

They still want hemostatic agents, but there have been problems with some types causing an embolus.

As of last week he said he was still using the clotting agents, so I don't think they've moved away from it just yet. He loves the stuff, and said that he knows for a fact it's saved at least three people he knows of personally.

As far as Celox or HemCon goes, I have no idea. I'm just trying to learn the basics of "medictry" right now without trying to learn all about the theoretical and experimental stuff.

 

[Afflixion]

The Army no longer uses Quikclot powder or the ACS (Advanced Clotting Sponge), we also no longer use HemCon anymore Quikclot reformulated their product and put it into kerlix and dubbed it "Combat Gauze" it's a hemostatic agent still but is formulated from some type of clay. I know they stopped using the previous forms due to full thickness burns when it was placed elsewhere. No clue as to why we stopped using HemCon as we just had it recalled about 3months ago. Also any level 2 or higher military treatment facility (MTF) carries whole blood, granted they carry O+ and O- only but they do carry it.

 

[Wildcat]

Quikclot in the military

There has been no movement away from Quikclot by the military. Every soldier and Marine carries it in his kit and every medic and corpsman has it. There haven't been any significant reports of problems with embolus with field use of Quikclot. The newer version of the product is a gauze infused with kaolin and is not the earlier granular product which was first in use.

I assume you're speaking of Quikclot, Papa? If so, the military is moving away from that last I heard.

They still want hemostatic agents, but there have been problems with some types causing an embolus.



Lucid, you bring up a good point about the other phase. In hospital, they really DO have the luxury of getting the blood type and giving the right blood, while PH we do not.

But I'm wondering if A) PolyHeme help a bit more with anemic pts, as opposed to just plain old trauma

and B ) if it'd be a better 50/50 mix with NS? Since they showed the NS control worked better, maybe mixing the goods of oxygen carrying items, WITH NS, would make a difference?




I know those scientist are smarter as a whole then me, but there are plenty of other ways they could have tested and tweaked.

 

[Wildcat]

Quikclot, military, FDA

It is my understanding that, not only is the military NOT moving away from Quikclot, but it is more committed to the product. What is being used today is a 3rd generation product that is significantly different from the initial granular product that was used several years ago. The drawbacks from the granular product were not those of performance as it worked extremely well to stop bleeding, but that it was somewhat difficult to rinse from the wound and it created an exothermic reaction with the water in the blood. The current products are surgical sponges and gauze that is infused with kaolin which is a coagulant. Every soldier, Marine and SEAL carries it in their personal aid kit and all medics and corpsmen carry Quikclot.

The FDA is currently relooking at all coagulant products and Quikclot has passed that review. Several other products which are currently being used are not likely to pass.

I assume you're speaking of Quikclot, Papa? If so, the military is moving away from that last I heard.

They still want hemostatic agents, but there have been problems with some types causing an embolus.



Lucid, you bring up a good point about the other phase. In hospital, they really DO have the luxury of getting the blood type and giving the right blood, while PH we do not.

But I'm wondering if A) PolyHeme help a bit more with anemic pts, as opposed to just plain old trauma

and B ) if it'd be a better 50/50 mix with NS? Since they showed the NS control worked better, maybe mixing the goods of oxygen carrying items, WITH NS, would make a difference?




I know those scientist are smarter as a whole then me, but there are plenty of other ways they could have tested and tweaked.

 

[Wildcat]

Quikclot, military and civilian

Quikclot is one of the primary products used by both the Army and Marines and they are not "moving away" from it. In fact, they now have Quikclot as part of every soldier's and Marine's personal aid kit. In addition every medic and corpsman carries a supply.

The original version of Quikclot was a granular product that was quite effective and is still used today, but there are other configurations that are also used in the form of gauze and surgical sponge. It is now available in the civilian world in the gauze or sponge form as well as the granular. I have used it in both forms and it is extremely effective, even used on patients who use blood thinners. There is even a version that is designed to deal with nosebleeds. It is being used in ER's as well as by EMT organizations and OR's.

 

[alphatrauma]

I wonder what the results would have been if they had crossmatched blood types for a 3rd control.

Like, make PolyHeme from an A+ blood sample, and put it in an A+ pt, and see the results.


(Yes, I know it's supposed to be a general supplement, but it IS science, so more info never hurts)

Looking at the data, it's not the antigen/Rh factor that caused the problem... it was hemoglobin toxicity.

 

[Akulahawk]

PolyHeme showed some promise, but... there seems to have been no significant difference between people resuscitated with it vs. conventional resuscitative measures. Also, they uncovered that about 3% suffered myocardial damage from PolyHeme. It very well could have been the hgb toxicity... IOW: it's no better, and actually possibly worse than standard resuscitation methods. So... they pulled it.

I'd have to look at the study data to see for myself... I haven't followed PolyHeme for about 2 years, so any studies newer than about 2008, I'm just not familiar with.

 

[PapaBear434]

PolyHeme showed some promise, but... there seems to have been no significant difference between people resuscitated with it vs. conventional resuscitative measures. Also, they uncovered that about 3% suffered myocardial damage from PolyHeme. It very well could have been the hgb toxicity... IOW: it's no better, and actually possibly worse than standard resuscitation methods. So... they pulled it.

I'd have to look at the study data to see for myself... I haven't followed PolyHeme for about 2 years, so any studies newer than about 2008, I'm just not familiar with.

Last I heard, it was the cost benefit vs. the actual benefit comparative to other traditional methods. It just didn't do anything as spectacular as they were hoping. It's unfortunate, because the idea sounded like a great break though.

 

[Akulahawk]

Either way, it still doesn't address the other issue... and that's platelet loss.