# Celox



## tomahawk6 (9 Feb 2007)

http://www.armytimes.com/news/2007/02/TNScelox070209/

Shell-based blood clotter works without heat
By Kelly Kennedy - Staff writer
Posted : Friday Feb 9, 2007 9:54:34 EST

A scientist walking down a beach in Washington state noticed lots of crabs with no legs — but none of them showed any signs of bleeding.

Most animals that lose a limb tend to bleed again after the initial injury, so the scientist wondered why the crabs had such clean wounds.

The answer: Most animals don’t have shells.

“It was the chitosan in the shells,” explained Limor Shemer, chief executive officer for SAM Medical Products. “It stopped the bleeding.”

The crustaceans’ natural body armor now serves a similar purpose for soldiers and Marines in Iraq and Afghanistan through a new quick-clot agent, Shemer said.

“The feedback’s been very positive,” she said. “It works regardless of temperature, and it doesn’t heat up.”

Unlike other quick-clot products troops have been using in the battle zone, the seashell product — called Celox — doesn’t depend on the blood’s natural clotting agent to work. Instead, the seashells bind with the person’s blood to create a clot.

That’s important, because other blood-clotting agents, such as QuikClot, need the blood to be a certain temperature. The agents can heat up to temperatures of 230 degrees Fahrenheit — enough to cause a second-degree burn. Celox also can be used on heparinized blood, or blood that has been treated so that it won’t clot on its own.

While HemCon — which is standard issue for troops in combat zones — also uses chitosan, studies have shown it doesn’t work as well to prevent bleeding because it is a dressing. Celox, which comes in granules, is poured directly onto a wound, and therefore works well on deep or arterial wounds, Shemer said.

Scientists at the Portsmouth Naval Center, N.H., applied Celox granules, HemCon bandages or QuikClot granules to pigs with severed blood vessels in their thighs after letting the animals bleed for three minutes. The study found that Celox reduced bleeding to nothing, HemCon to 33 percent and QuikClot to 8 percent, as opposed to a standard dressing, which brought bleeding down by 50 percent.

“Although all three agents were superior to standard dressing with regard to re-bleed, only Celox improved survival in a lethal hemorrhagic groin injury compared to standard dressing,” wrote Lt. Cmdr. Buddy Kozen in a letter about the study.

Celox was approved by the FDA in June, and has been used in the war zones by Special Forces medics since September, Shemer said.

Studies also found that even if Celox gets wet or is kept in humid conditions, it may get clumpy, but it still works. It can also be easily rinsed from the wound, Shemer said.


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## Armymedic (9 Feb 2007)

If this will take any and all severe bleeds I can encounter in the field down to nothing...then wow.

But the cost per unit item is...?

If we can get 5 packs of QC issued to the troops for the cost of one pack of this new antihemmoragic agent...which is really better?


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## muskrat89 (9 Feb 2007)

SMMT - I couldn't find pricing anywhere, but here is their site. Maybe you could contact them for a cost  http://www.celoxmedical.com/


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## tomahawk6 (9 Feb 2007)

SAM is a distributor of celox.

SAM MEDICAL PRODUCTS® 
7100 SW Hampton Street, Ste 217 
Portland, OR 97223 USA 

503-639-5474 Phone 
800-818-4726 Toll Free 
503-639-5425 Fax
www.sammedical.com

Pdf article.
http://www.defensereview.com/stories/celox/CELOX_Hemorrhage%20Control-%20When%20Seconds%20Count.....pdf

Looks like its packaged to be seen if medic is wearing night vision device.


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## Donut (9 Feb 2007)

Impressive, for sure!

DF


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## Fraser.g (9 Feb 2007)

Just the fact that it is not exothermic is a big bonus. 
As to the cost, what is the cost of the rehab from a burn inside a wound VS no burn?
If it works and the literature can prove it then lets get it out there!


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## Sawbones (9 Feb 2007)

Whoa, folks, slow this parade down!

1.   This product is not approved by Health Canada
2.   This product is not approved by the Canadian Forces.
3.   This product is not recognized by the US military*.
4.   This product does not yet even have an NSN.

*: Some SOF medicals buy whatever they want and use it. They have their own procedures for acquiring kit. 'nuff said.

This product was given FDA device approval based on it being "traditional", it had the same basic ingredient as HemCon.  That doesn't mean it works, just that the device should not be dangerous in itself based on previous use of the ingredients.  No peer-reviewed publication, either clinical or animal has been published.  This has not stopped the manufacturer from claiming it has proprietary effects or is better than other dressings.  Six pigs in Portsmouth doesn't impress me.

We have a procedure for evaluating and issuing new hemostatic agents in the CFHS.  The CF Combat Casualty Working Group, including CF trauma surgeons evaluate new products on a regular basis.  What is issued are products that have been demonstrated to be the safest and most effective for CFHS use.  

The surgeons are the ones who finally see and deal with all these wounds, Quikclot and all, they know what they want in these wounds.  Quikclot works okay, this Celox stuff may be good too, but it is too early.

If you want to make suggestions, you certainly can tell them.  

So it is an interesting product and one can buy anything one wants off the internet (this stuff is $15.95 US a package) but if you use it on a an actual casualty, and anything goes wrong with that casualty, there will be very unpleasant questions asked afterwards.  Conducting an impromptu clinical trial using an unapproved dressing without authority or patient consent is likely to cause some trouble. 

As the DS used to say when someone over-anticipated the word of command,

WAIT FOR IT!!!

Sawbones


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## Armymedic (9 Feb 2007)

Sawbones said:
			
		

> We have a procedure for evaluating and issuing new hemostatic agents in the CFHS.  The CF Combat Casualty Working Group, including CF trauma surgeons evaluate new products on a regular basis.  What is issued are products that have been demonstrated to be the safest and most effective for CFHS use.



Sorry for the slight hijack:
This group...is it the one holding up the issuing of FASTs (sternal IOs)?


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## tomahawk6 (10 Feb 2007)

If the SF medics use celox I think its good to go. Its another tool in the medics kit. I understand the bureaucracy and the need for safety but if the US FDA approves it surely Health Canada cant be far behind ?


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## medicineman (10 Feb 2007)

Health Canada doesn't follow that quickly behind the US actually - however, if the CF feels it's needed, they'll apply for special access (like with HI-6, morphine auto injectors and such).

MM


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## Sawbones (10 Feb 2007)

St Micheal's:  Actually committee members looked at new data from OEF and Roto III MedTechs were introduced to the Pyng FAST1 during January predepolyment training at Wainwright.  Don't know how many will be issued.  Past concerns with the Pyng have been the need to remove the ballistic vest and real difficulties in getting the needle out afterwards..

There are already two I/Os in the system now, the WaisMed B.I.G. from the Israelis and the older Cook "doorknob" needle, which still works is all ages.  MOs, NOs and PAs going to CFTTC(W) are trained on the B.I.G. I/O. In all 2006, I am aware of only two cases where I/O was used in casulaties going to R3MMU.   I/O just doesn't get much use in trauma, its used much more in cardiac cases, ODs and burns.

The C3WG is pretty switched on, they are providers, not desk jockeys and if you deployed you probably met some of them.  They're the folks that developed TCCC into the Army. Their recommendations are usually adopted rapidly by Surg Gen, delays are usually due to training, regulatory or supply issues.  There are more goodies in the pipeline, but for instance Actiq fentanyl lollipops and Rescueflow hypertonic saline are still waiting for Health Canada SAP approval.

Tomahawk6:  Just because SOF uses it, doesn't mean its right, or right for the rest of us.  If you're a CF provider and deliberately use a non-approved dressing instead of the dressings you were issued and trained to use, and that soldier does good or bad, it won't matter whether its your fault or not, someone is going to find out and find you. Starting a impromptu clinical trial in a war zone without authority or informed patient consent may not be your best career move.  Every wound gets examined at base, and the dressings are documented in the combat trauma registry.

Clinicians have to stick to what's in the formulary and its the same for everyone else.  Otherwise it will be all cowboys and witchcraft and nobody will know what the heck's going on.  That's why its an army and not a shooting club.

Sawbones


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## tomahawk6 (10 Feb 2007)

You sure have the book down Doc. I agree with you about prudence and following regulations. You certainly wont ever get into trouble by following the book.


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## Sawbones (10 Feb 2007)

I am enjoying these combat arms types way over in the medical lanes.

Well, I had the experience last year of examining a deceased casualty with an non-approved dressing in his wound.  He probably would have died anyway, but our own TTPs weren't followed by a MedTech or TCCC provider probably treating one of the first bad torso wound casualties he'd ever seen.  Somebody probably somewhere told him to buy and use it, but it wasn't a product adopted by the CF.   Not a good experience.   Thats not being innovative, that's ignoring your seniors and your training.  I wonder if he's still out there somewhere wondering if he did the right thing?

We have a process to examine medical lessons learned and adopt new medical TTPs.  It works.  This is heathcare, not fighter tactics and it won't get solved in these lanes.  This product will be examined, but it doesn't meet criteria for use yet in my opinion.  This isn't a better tactic, just a new idea and pretty much untested in humans.  You wanna be first?

There is no "book", and there is no "them" but there are best practices, and if you don't want to listen to people to have already been there and done that, but use hearsay and products without a background but a couple of internet articles, then you have no tactics at all.  The wounded need the best possible care to maximize survival by people using proven techniques.  Innovation does occur, but in a controlled fashion, otherwise its human experimentation.

Sawbones out.


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## Armymedic (10 Feb 2007)

> There are more goodies in the pipeline, but for instance Actiq fentanyl lollipops and Rescueflow hypertonic saline are still waiting for Health Canada SAP approval.


Perhaps my angst is misdirected against the committee and should be directed at others. 

I am sorry to hijack this into a IO discussion.


			
				Sawbones said:
			
		

> St Micheal's:  Actually committee members looked at new data from OEF and Roto III MedTechs were introduced to the Pyng FAST1 during January predepolyment training at Wainwright.  Don't know how many will be issued.  Past concerns with the Pyng have been the need to remove the ballistic vest and real difficulties in getting the needle out afterwards..
> 
> There are already two I/Os in the system now, the WaisMed B.I.G. from the Israelis and the older Cook "doorknob" needle, which still works is all ages.  MOs, NOs and PAs going to CFTTC(W) are trained on the B.I.G. I/O. In all 2006, I am aware of only two cases where I/O was used in casualties going to R3MMU.   I/O just doesn't get much use in trauma, its used much more in cardiac cases, ODs and burns.



Is not teaching just MO, NO and PA on IO defeating the purpose of a prehospital vascular access method? One where medics would use in cases where they are not able to access anticubital veins. Perhaps there would be more cases showing up at R3MMU if all medics in the CF could use an IO. Who were the providers who put in the IO in the cases you know about?

Also, I am quite familiar with all three IO delivery systems you mention above. 
The Cook is great for kids...not so fun to put in adults, and required to be put into the tibial plateau. And needs to be screwed. Not exactly comfortable for the patient, nor easy for the provider.
Same placement for the BIG. It is extremely painful, and requires no possible fracture to the lower leg. And does not always work. (about 30% of the time). Removal is easier then FAST, but still problematic.
The FAST goes in high on the sternum and the ballistic vest front only needs to be removed for a minute or so during installation. Also there is quite a significantly less likelihood of a sternum fracture vs a tibia fracture. Removal requires a small tool as you mention, which needs to be sent with the line. The tool is often forgotten, but that can be mitigated by good training. There is a risk of the penetrator being left in the bone if removal is not done properly, but that can be corrected by minor surgery, and mitigated by minor surgery.

My opinions are that the Cook IO is a waste of time and money for soldiers. The BIG is not the most effective tool given the nature of majority of injuries in Afghanstan (lower limb blast type). Why are we not pushing to get FAST (which has been on the market longer then the BIG, I seen a demo in 2000) in the hands of all our Med Techs quickly?


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## Fraser.g (10 Feb 2007)

The FAST is stocked and issued to SF medics, as well as the Role 3 now with a move afoot to get it lower for all the reasons you stated above.


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## Armymedic (10 Feb 2007)

RN PRN said:
			
		

> The FAST is stocked and issued to SF medics, as well as the Role 3 now with a move afoot to get it lower for all the reasons you stated above.


Canadian SF? Doesn't help out the rest who could use it, because:



			
				Sawbones said:
			
		

> Tomahawk6:  Just because SOF uses it, doesn't mean its right, or right for the rest of us.


That thought is the norm through the medical group. Even though its SOF who gets to use and prove the stuff.


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## Limor - SAM LSI (11 Feb 2007)

Hi To all,
My name is Limor and I am with SAM Medical Products, CELOX's 
exclusive representative Wordwide.
CELOX will be Health Canada approved within the next 2 months or 
sooner.
I am pleased to inform you that we attended a live-tissue training in 
Dallas about 2 1/2 weeks ago.  The training included all three hemostat 
products, QuikClot, HemCon and CELOX.
One of the Army Docs, who attended the TacMed course, inspected 
the wounds which were controlled by the above mentioned hemostatic 
products.  The Doc found out that CELOX not only stopped the arterial 
bleeding, it actually repaired the damaged artery.  The Doc easily 
removed all the CELOX product from the wound, cleaned the cavity 
very well and yanked / agitated the leg very hard – he also 
scratched the artery with his finger nail and scissors.   No re-bleed 
occur!!!   The Doc demonstrated it three more times by pocking holes 
in the artery with 18 gage needle, applying USED CELOX from other 
wounds, and cleaning the wound with saline water.  The doc was able 
to re-confirm that the artery was completely sealed and repaired – no 
signs of re-bleed !  
The recorded MAP during this demo was over 90 !!!
The artery was partially transected and stabbed.  
We have a clinical report conducted by Portsmouth Naval Hospital
which compaired all 3 hemostat products: HemCon, QuikClot and CELOX.
If you wish to get a copy of the report and additional information, please
feel free to email me at: limor@sammedical.com 
Thanks - stay safe, Limor


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## Limor - SAM LSI (11 Feb 2007)

My name if Limor - SAM Medical Products, CELOX exclusive representative worldwide.
i am pleased to share with you that CELOX will be Health Canada approved within the
next couple of months !
CELOX was clinically tested by Portsmouth Navy Hospital and was compaired to HemCon,
QuikClot and a standard field dressing.
I will be happy to share with you a copy of the report and additional clinical information
upon request.  Please feel free to contact me at: limor@sammedical.com

Thanks - have a nice weekend, Limor


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## tomahawk6 (11 Feb 2007)

Thanks Limor for dropping by.Very informative post about the military testing of celox.


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