Use of Absorbable Hemostatic Agents by EMS Agencies

[trauma74 111]

Click on the PDF attachment to read the HVREMSCO approval of Absorbable Hemostatic Agents.

HemostaticAgents.pdf

Edited November 10, 2007 by trauma74

[Guest alsfirefighter]

Good to see they are catching up. One agency I work for has been utilizing quik clot for some time now and the past year or so Celox. I both of those and also carry HemCon dressings as a tactical medic.

I personally like Celox the best and have great success with it when needed. They are in the process of coming out with a bandage like QuikClot did to alleviate the issues with wind that were noted by the military. Discussions I've had with Celox reps said they are also looking at an applicator where you will actually be able to inject the product through a syringe like device.

QuikClot's newer formula from what I understand is much better then the older being it doesn't get as hot. Their first response bandage was an awesome idea and I also carry that in my tac vest.

These agents are very safe and highly effective and I've had some very interesting learning experiences as I've researched them for presentation purposes. Hopefully Westchester will move soon on these as well.

[PVFD233 68]

Topic at St Francis 10th Annual Trauma Conference, and what was said is thy work great and it looks like QuikCLot would be the choice.

[Guest alsfirefighter]

QuikClot is the agent approved by NTOA.

As I've stated I prefer Celox over QuikClot but the bandage has its uses for me in certain types of traumatic wounds I've dealt with and potentially could deal with as a tac medic.

SPFC...it you don't mind sharing and hopefully we'll spark some additional coversations with others...

why you feel QuikClot is the choice. Is that your personal liking? Or agency?

[PVFD233 68]

Have not been able to see any in action, I have a packet of the slides involved in the lecture if you would wish. I can scan when I get a chance and send them to you. The whole topic was interesting. Alot of the topic included the use of it in Iraq. Very Intreresting. If I do remember though QuikClot is much more stronger coagulating the wound.

[Guest alsfirefighter]

Thanks for the offer brother. I actually have a presentation on all 3 that I've developed for CME lectures and for when I teach tactical medic topics.

Funny enough all 3 boast adherency as a pro of their product. I've never seen any difference between Celox and QuikClot in the field. I have yet to use HemCon in the field but from Navy trauma surgeons HemCon adheres awesomely. I have the pig test video that they conducted and it does really seal that wound well.

By any chance did David Hajdu do the presentation from Z-Medica on the QuikClot? He is a very nice guy and handles this area for Z-Medica.

Edited November 11, 2007 by alsfirefighter

[trauma74 111]

Alsfirefighter,

Do you have a copy of a policy you can send me regarding the hemostatic agents? I want to come up with a good comprehensive policy to bring to our medical director. Thanks.

[ny10570 745]

All right, so everything I have ever heard about these products has been overwhelmingly negative until now. Someone care to educate us outside the loop?

[Guest alsfirefighter]

All right, so everything I have ever heard about these products has been overwhelmingly negative until now. Someone care to educate us outside the loop?

10570...I'm interested in what negatives you have heard and if you can share I will what I have learned, experienced with use or read. The only one I know of is the original formula QuikClot could reach high temperatures being with contact with fluid it has an exothermic reaction. The stuff still worked very well though I just didn't like it because of that. The new formula doesn't get as hot as the old and I believe will not exceed around 104 degrees.

Otherwise brother I have to apologize...I might not be able to divulge to much stuff being I offer a lecture on the agents.

Trauma...if you still have my email address email me and I can point you in the right direction and if your interested we can discuss if you'd like a CME on the topic at your agency. If not PM me.

[NYMedic37 22]

Alsfirefighter,

Do you have a copy of a policy you can send me regarding the hemostatic agents? I want to come up with a good comprehensive policy to bring to our medical director. Thanks.

Tarrytown EMS has had Quicclot on our ambulances for a little while now. I don't think anyone has used it yet but in training looks very promising.

[ny10570 745]

Everything I know about Hemostatic Agents is complete hearsay. Its not discussed much and I had little motivation to pursue much info as it didn't look like they were coming anytime soon.

The heat was an issue brought up, but the numbers were in excess of 120. Enough to potentially cause thermal injury. They made debridement difficult and were contributive in many post-op complications. Overwhelmingly negative may have been a bit of an overstatement, but in this area with transport times being less than 20 minutes to a Trauma Center in most cases and often only a few minutes to the nearest hospital it seemed unnecessary.

So without ruining this portion (I'm waiting for the DVD) of the "ALS Presents CME Series" what am I missing? Or just give the whole thing away and bill Seth.

[Guest alsfirefighter]

Heat was an issue and I had a patient that got a 1st degree burn with about 1 blister from the use of QuikClot old formula. I attempted to dry off the area around his wound being it was summer and he was sweaty but I guess it was still moist enough around it and a little of the product got on the edges of the wound.

As far as transport times, there is a time and a place for everything. This is an adjunct to BLS bleeding control and one that works wonders. I've used it on surgical wounds that have opened, vericose vein ruptures (we know how these get) and arterial and arteriolar bleeds. Also keep in mind even with short txp times, it still gives the ED a chance to get a hold and work a bit more controlled then the mad rush to stop the bleeding.

In the tactical medical world they are god sends to assist in stopping bleeding where manual direct pressure isn't an option when you have to move. The combination of product, with an israeli trauma bandage allows myself and my partner to get some control on bleeding if need be prior to moving my guy out and to the trauma center.

As far as wound debridement I've never heard of nor experienced any complications so I don't know where that came from. None of these products form a hard clot. The powdered products when the clot forms can be rinsed away with saline flushes. HemCon which is a bandage and does adhere to the wound also is released by wetting the sponge. Again I'm not sure who passed that info to you but it almost sounds like they heard it from someone who heard it from someone who heard it from someone type of deal.

What are you missing? A wonderful adjunct to hemhorrage control that has been now proven in combat to be highly effective. The big 3 have all gotten exposure in Afghanistan and Iraq. Some are pricier then others, some have cons that others don't in application. But none have any reactivity or sensitivity concerns for any patient and flat out work. Contact each manufacturer they will send you info and if you are really nice they often will send a free sample of their material. The only thing is you obviously have to have the situation to use it.

I hope you're not upset bro about the CME comment, I'm partly joking but partly do have to protect what I do on the side.

[ny10570 745]

No, not upset at all. You absolutely should be rewarded for your knowledge and expertise. Thanks for the info.

Edited November 13, 2007 by ny10570

[WAS967 97]

FYI, such a policy has existed from the Westchester region since 2004. Wonder what took the Hudson Valley Region so long to catch up?

BTw....found this on the WREMAC site. Interesting information that should be mandatory reading for all users:

FDA Public Health Notification: Paralysis from Absorbable Hemostatic Agent

(You are encouraged to copy and distribute this information)

Issued: 4-2-2004

Dear Surgeon:

This is to remind you of a rare but devastating adverse event that can occur with the use of an absorbable hemostatic agent, a device used to promote coagulation and stop internal bleeding during surgical procedures. Unfortunately, these events continue to occur despite specific advice and warnings in the device labeling. We ask that you take action to minimize the risk in your patients and help spread the message in this announcement.

Nature of Problem

Since 1996, FDA has received reports of over 110 adverse events related to absorbable hemostatic agents. Eleven of the events resulted in paralysis or other neural deficits. The last reported paralysis occurred in October, 2003. The common thread in all 11 events was an absorbable hemostatic agent that was used on or near a bony or neural space and left inside the patient. When wetted, the material swelled and exerted pressure on the spinal cord or other neural structures, resulting in pain, numbness or paralysis. In some cases, blood pooled behind the implanted absorbable hemostatic agents, forming a hematoma that exerted pressure on neural tissues and caused a range of neural deficits.

Although these events are rare, they can have serious consequences. These consequences are preventable.

Recommendations

FDA recommends that users of absorbable hemostatic agents review the device labeling, especially the contraindications, warnings and precautions.

If you use an absorbable hemostatic agent on or near bony or neural spaces:

* use the minimum amount necessary to achieve hemostasis; and,

* remove as much of the agent as possible after hemostasis is achieved.

This will reduce the likelihood of neural and other soft tissue damage from swelling of the absorbable hemostatic agent, and/or migration and swelling of fragments of the agent.

Reporting Adverse Events to FDA

FDA requires hospitals and other user facilities to report deaths and serious injuries associated with the use of medical devices. If you suspect that a reportable adverse event was related to the use of an absorbable hemostatic agent, you should follow the reporting procedure established by your facility.

We also encourage you to report adverse events related to absorbable hemostatic agents that do not meet the requirements for mandatory reporting. You can report these directly to the device manufacturer. You can also report to MedWatch, the FDA’s voluntary reporting program. You may submit reports to MedWatch by phone at 1-800-FDA-1088; by FAX at 1-800-FDA-0178; by mail to MedWatch, Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857-9787; or online at http://www.fda.gov/medwatch/report.htm.

Getting More Information

If you have questions about this notification, please contact Ms. Quynh Hoang, Office of Surveillance and Biometrics (HFZ-510), 1350 Piccard Drive, Rockville, Maryland, 20850, Fax at 240-276-3356, or by e-mail at phann@cdrh.fda.gov. You may also leave a voice mail message at 240-276-3357 and we will return your call as soon as possible.

FDA medical device Public Health Notifications are available on the Internet at http://www.fda.gov/cdrh/safety.html. You can also be notified through email on the day the safety notification is released by subscribing to our listserv. To subscribe, visit: http://service.govdelivery.com/service/sub...de=USFDACDRH_10.

Sincerely yours,

David W. Feigal, Jr., MD, MPH

Director

Center for Devices and Radiological Health

Food and Drug Administration

[Guest alsfirefighter]

Eleven of the events resulted in paralysis or other neural deficits. The last reported paralysis occurred in October, 2003. The common thread in all 11 events was an absorbable hemostatic agent that was used on or near a bony or neural space and left inside the patient. When wetted, the material swelled and exerted pressure on the spinal cord or other neural structures, resulting in pain, numbness or paralysis. In some cases, blood pooled behind the implanted absorbable hemostatic agents, forming a hematoma that exerted pressure on neural tissues and caused a range of neural deficits.

Still beats bleeding to DEATH!

These materials are just like any other administer agent, they all carry risks and side effects. They are calcuable. These same areas that this can and/or has occurred are places that in many cases direct pressure is impossible and/or ineffective.

I'm not sure of what hemostatic(s) they are referring to but I'd be interested to know. None of the agents I am familiar with, "swell" when in use, at least noticably. There are documented cases in Afghanistan and Iraq that these materials have been packed in wounds and stayed for hours and in a couple of cases days for special ops guys. There is little risk in the pre-hospital field, and if you take note the memo is addressed as "Dear Surgeon" leading me to believe they were trying these in surgical cases to control difficult bleeding situations.

Thanks for sharing that WAS.