Can we talk about sequence of operations?

[Iraqgunz]

Yes, at least as far as I remember. It had to do with the Army and their recent decision to suspend the use of Wound-Stat. Something about thrombosis or something being caused by the agents. I believe that our guys did say that Celox or the bandage that has the hemostatic agent in it are much better.

My feeling is that if a person is bleeding and direct pressure/ bandage has failed and the tourniquet has failed (obviously where appropriate) then the hemostatic would then be applied. Maybe my thinking is wrong on this. But, as I said everything is situation dependent.

So they recommend that hemostatic agents be applied only after the tourniquet has failed?

[rob_s]

From what I understand, the newer products like Quick Clot ACS (which is the same as the commercial Quick Clot) in the sponge/bandage alleviates a lot of the problems they were having with the earlier generations.

Can any of the IP/SMEs shed some light on this?

[Iraqgunz]

This was posted over at SOCNET and I thought it pertinent to the discussion.

FROM
CDRUSAMMA FT DETRICK MD//MCMR-MMO-SO//

***PRIORITY***MESSAGE NOT RELEASED

****************UNCLASSIFIED****************

SUBJ: T0B-1218-002
NEW SOLDIER HEMOSTATIC DRESSINS / WOUNDSTAT / MEDICAL INFORMATION


REFERENCE: ALARACT 239/2008, NEW SOLDIER HEMOSTATIC DRESSINGS

1. THIS FRAGO DIRECTS TEMPORARY CESSATION OF USE OF WOUNDSTAT™ (WS) BY 68W
COMBAT MEDICS AND ALL OTHER PROVIDERS DUE TO NEWLY IDENTIFIED SAFETY CONCERNS
ABOUT THIS PRODUCT, PENDING FURTHER EVALUATION.

2. WOUNDSTAT™ WILL BE TURNED IN TO THE MEDICAL SUPPLY SYSTEM IMMEDIATELY.
UNIT SUPPLY PERSONNEL WILL TURN -IN WOUNDSTAT™ TO THEIR SUPPORTING MEDICAL
SUPPLY SUPPORT ACTIVITY (SSA). THE ARMY MEDICAL SSA WILL REVIEW TRANSACTION
REGISTERS AND COMPLETE 100% CONTACT WITH UNITS ISSUED WS TO ENSURE TURN-IN
OF PRODUCT. ARCENT WILL SUBMIT THE TOTAL NUMBER OF WS ISSUED AND COLLECTED
TO OTSG. THE ARMY MEDICAL SSA WILL HOLD WS UNTIL FURTHER NOTICE OR UNTIL DISPOSITION
INSTRUCTIONS ARE RECEIVED FROM OTSG.

3. DATA FROM THE US ARMY INSTITUTE OF SURGICAL RESEARCH (USAISR) SHOW THAT
WS IS ASSOCIATED WITH A HIGH INCIDENCE OF BLOOD VESSEL THROMBOSIS AND DAMAGE
TO THE VESSEL WALL. COMBAT GAUZE AND PLAIN KERLIX WERE NOT ASSOCIATED WITH
SIMILAR FINDINGS. USE OF COMBAT GAUZE IS SAFE, ACCORDING TO CURRENT STUDIES,
AND DISTRIBUTION AND USE SHOULD CONTINUE.

4. MEDICAL PERSONNEL MUST LOCATE AND EXAMINE ALL CASUALTIES PREVIOUSLY TREATED
WITH WS TO VERIFY ADEQUATE LIMB PERFUSION, IF WS WAS USED TO TREAT EXTREMITY
WOUNDS.

5. EXPIRATION DATE CANNOT BE DETERMINED.

[joker581]

Joe pretty much nailed it from an EMS perspective. For care under fire, or in a generally hostile environment, a different sequence of events may be preferrable.

If you are taking fire, the best thing you can do for a wounded man is to maintain fire superiority and get him out of there. It is critical that you unass the area as quickly as possible and get to a place where you can provide care.

Bleeding control is obviously very important. You only have a limited amount of blood to begin with and it is lost rapidly when you are shot. If you are able to devote a lot of time, skill, and material to a casualty, then it is best to go through all of the steps outlined above. If not, you are better off applying a tourniquet and moving on. The potential for a lost limb is well established, but a lost limb is preferable to a dead patient if bleeding cannot be controlled and the simple fact is that a properly applied tourniquet will stop(or at least significantly reduce) bleeding immediately.

In my opinion, if you aren't able to immediately evacuate your casualty to a place that can provide more care, a tourniquet is the way to go for severe wounds.

[Iraqgunz]

Here is another from SOCNET about the subject.

Dear Dr. F,

I am writing this letter in response to your request for an unbiased opinion concerning the decision of the Army to temporarily remove WoundStat from clinical use until it could further evaluate the findings from an animal study that raised concerns about its safety. To clarify my position, I am the Chief of Trauma and Surgical Critical Care at Oregon Heath & Science University, which is a Level 1 Trauma Center and I have an active xxxxxxx research laboratory that studies hemostatic dressings. I am also a member of the US Army Reserves assigned to the Institute of Surgical Research (USAISR) and I have been deployed to Iraq where I utilized hemostatic dressings in the care of combat casualties. I have no pre-existing affiliation with WoundStat or TraumaCure and my primary interest as a trauma surgeon is to achieve the best possible outcomes for civilian and military casualties.

My opinion is based on a review of both published and unpublished studies comparing WoundStat to other dressings for safety and efficacy as well as discussions with experts in the field and personal experience with the dressing. The latest published guidelines of the Committee on Tactical Combat Casualty Care (TCCC) indicate that WoundStat should be used as a backup to Combat Gauze for compressible hemorrhage not amenable to tourniquet use or as an adjunct to tourniquet removal in the tactical field care environment. Studies comparing the efficacy of WoundStat to other dressings have been performed by the Virginia Commonwealth University (VCU), North America Science Associates (NAMSA), the US Air Force, the US Navy and the US Institute of Surgical Research. Ex vivo studies in normal blood, heparinized blood, blood with anti-platelet agents and diluted blood all reveal that WoundStat increases coagulability suggesting that at least part of the dressings’ effect is due to activation of the coagulation system. The dressing has also been noted to function by creating a sealant effect by its conversion to a clay form which has memory and confers compression even after manual pressure has been removed.

Pre-clinical trials have been performed in xxxxx models. These models have primarily involved femoral artery and/or vein punctures with uncontrolled hemorrhage followed by placement of study dressings with a variable compression period and resuscitation. These models are considered to be 100% lethal when treatment is with standard dressings.

Study endpoints have included short term survival, blood loss, resuscitation volumes and laboratory values. The numbers of xxxxx per group ranges from 5 to 10 and there are generally multiple dressings studied. These analyses are underpowered to show differences in survival or blood loss unless the differences are very large. Studies performed by VCU, NAMSA, Travis Air Force Base and the USAISR have revealed a 100% survival rate in xxxx treated with WoundStat. No other dressing achieved 100% survival rates in any of these studies. xxxx treated with WoundStat also had less than 10 ml/kg of post-treatment blood loss which was numerically less than any other dressing. The USAISR performed the only study that compared WoundStat to Combat Gauze. In this study, xxxxx treated with WoundStat had 100% survival compared to 80% for Combat Gauze. Blood loss was approximately 10 ml/kg in the WoundStat group versus approximately 40 ml/kg in the Combat Gauze group. These differences in survival and post-treatment blood loss did not achieve statistical significance. Histologic changes in tissues treated with various dressings were analyzed in the USAISR study and they were graded as mild to moderate tissue injury in both the combat gauze and WoundStat groups. Also of note, the USAISR has performed computed tomography angiograms to evaluate injured femoral vessels after they have been treated with various dressings and these studies have revealed that all agents have resulted in obstructed blood flow. These preliminary studies have uniformly shown excellent efficacy of WoundStat resulting in tremendous enthusiasm for its use and its addition to the TCCC guidelines as a secondary agent when Combat Gauze fails or the wound is more amenable to a granular agent.

Studies showing evidence of tissue injury and obstructed blood flow with hemostatic dressings induced the USAISR to produce a new model that was primarily designed to test safety in larger blood vessels. This model involves dissection of the carotid artery and external jugular vein followed by clamping and a 50% transection of both vessels made with scissors. Free bleeding is allowed for 30 seconds after which dressings are placed and compression is held sequentially until hemostasis is secured. xxxx are resuscitated with 500 ml of Hextend followed by LR to maintain a mean arterial pressure of 65 mmHg. Dressings are left in place for 2 hours and subsequently removed. The vessels are then primarily repaired and blood flow is restored. During the repair, xxxxx are given 1 liter of lactated Ringer’s. The wounds are subsequently closed. Heparin is not utilized either locally or systemically. Two hours after blood flow is restored, the wounds are reopened and blood flow is assessed with computed tomography angiography. The wounds are then reopened and blood flow is confirmed. Histology is obtained from the injured vessels as well as from lung and brain to look for evidence of material or clot embolization.

Combat Gauze, WoundStat and kerlix were compared utilizing this model. Post-treatment blood loss was significantly greater in the kerlix group but not significantly different between Combat Gauze and WoundStat. Combat Gauze and WoundStat xxxxxxx also required significantly less total compression time. In terms of safety, 7 out of 8 carotid arteries and 6 out of 8 jugular veins treated with WoundStat developed occlusive thrombi. All vessels that were treated with Combat Gauze and kerlix were patent but there was restricted flow in some of the vessels treated with these agents. There was also a large clot and WoundStat residues found in the lung of two xxxxxx that were treated with WoundStat. Histology revealed transmural injury in all vessels that were treated with WoundStat. Histologic changes associated with Combat Gauze and kerlix use were reported to be mild and equivalent.

It is important to note that QuikClot shares some common characteristics with WoundStat. QuikClot is a granular agent that has been shown to have pro-coagulant effects in vitro which are similar to WoundStat. QuikClot has the disadvantage of being an exothermic agent that induces thermal injury. QuikClot has been used extensively by military and civilian agencies. There is a published report of its use in 103 patients and neither pathologic vessel thrombosis nor embolization has been reported. QuikClot has not been studied in the USAISR safety model.

There have been scattered verbal reports of WoundStat use in human patients. However, to my knowledge, none of these reports have been published to date. Additional studies evaluating WoundStat for safety and efficacy are either planned or ongoing.

Based on the available data, I would make the following observations:

1. WoundStat is extremely effective in xxxx models of lethal hemorrhage. The trials that have been performed have been small and they do not have the power to distinguish the efficacy of WoundStat compared to Combat Gauze.

2. The findings by the USAISR of full thickness vessel injury and thrombosis associated with the use of WoundStat are of some concern. It is not clear if these finding are related to a mechanical effect of WoundStat related to the product’s intrinsic memory and its ability to maintain pressure when compression has been removed, an abrasive quality of the granules or a chemical reaction of the product. These findings should be interpreted within the scope of the xxxxx model. Similar to the femoral vessel injury model, the cervical model involves dissection of the vessels and partial transection with scissors exposing the vascular endothelium. The injuries were primarily repaired. This differs from injuries seen in combat in that those injuries generally involve high energy impact with significant damage to the vessels and surrounding tissues. The vast majority of these injuries require resection of injured vessels to healthy areas and interposition grafting. In addition, either systemic or local heparinization is used in clinical settings to help achieve prolonged patency. Finally, xxxxxx are a hypercoagulable xxxxx compared to humans. Further research studying the etiology of the thrombosis and endothelial injury seen with WoundStat as well as comparing WoundStat and Combat Gauze in injury models associated with high energy and the use of interposition grafting would help clarify the relative safety of these two products in realistic settings. It would also be interesting to test QuikClot in the USAISR cervical model to help determine if the findings seen with WoundStat are reproduced with another FDA approved agent that has similar characteristics.

3. It is not uncommon for potent hemostatic agents to cause thrombosis or systemic complications when they are exposed to the vascular endothelium. Topical thrombin which is used on a widespread basis by surgeons to control bleeding is contraindicated for intravascular use or for the treatment of brisk arterial bleeding. This has not prevented thrombin from being used widely for severe bleeding.

In conclusion, WoundStat is a granular hemostatic agent that differs mechanistically from tourniquets and Combat Gauze, expanding the medics’ ability to stop bleeding in extreme scenarios. In light of WoundStat’s intrinsic hemostatic capacity compared to preliminary data suggesting its potential for causing injury to blood vessels as well as thrombosis and embolization, it seems reasonable to continue using WoundStat when other measures have failed especially when the alternative is death. The safety of WoundStat has not been studied in realistic models that include modern vascular replacement techniques and heparinization. Furthermore, the use of WoundStat should be safe and potentially lifesaving in coagulopathic patients in whom large vessel bleeding has been controlled and exposure to vascular endothelium is limited. Both recombinant factor VIIa and tourniquets are commonly used to treat combat casualties. These agents have known complications that are limited by using them appropriately and the same concepts should be applied to WoundStat.

[rob_s]

I wonder how that carries over to Quick Clot, specifically the ACS and others that are part of a sponge. IIRC, Wound Stat is typically applied in the granulated form.

[Decon]

That letter states it very well. There will be situations and certain wounds where the basic steps will have little effect and it's nice to have another option.

I would learn to know the difference between a wound that will be treated well with the basic steps and a wound that will need aggressive treatment.

As always, the best tactical medicine is overwhelming force. Medicine is much easier when you remove the tactical.

[Gutshot John]

The ACS is an improved application that works well for simple TnT gunshot wounds. It's packaged in pairs (entrance/exit wounds) which makes things convenient.

They won't work well for something like a traumatic amputation, though they are probably all the hemostat that most people here will need relevant to GSW.

Things like CELOX applicator use the granulation to place it very specifically into the wound.

For simplicity's sake, I'd confine things to impregnated dressings. It just eliminates a step.

[Doc Solo]

A few things to bear in mind when talking about bleeding control in the face of penetrating trauma, especially if there is an ongoing threat.

The sequence is exactly as IraqGunz said, massive bleeding is actually prioritized above airway, and tourniquets are emphasized much earlier in the bleeding control sequence due to the speed that they can control bleeding and the over-arching needs of the existing tactical situation. Stopping the shooter/s results in less of us getting shot. Shot officers/soldiers are assets that need to be kept in the fight. Tourniquets are fast and can be converted to pressure dressings later after the fight is over. Stair stepping up thru the bleeding control continuum just allows the casualty to bleed more. But this is situation dependant as people have already talked about.

There are a few take home points for using hemostatics. They fill a couple niches wherein we prioritize their use sooner. These niches are severe bleeding that isn't easily compressible or isn't being controlled by direct pressure, or can't be tourniqueted.

A: The neck, large vessels, difficult to compress, there are some bandaging possibilities, but you have to be creative so as not to compress vessels on both sides, or the airway.

B: Axilla(armpit), likewise, large vessels, somewhat easier to compress, but difficult to tourniquet.

C: High femoral/groin: large vessels again, sometimes you can get a tourniquet high enough to actually act as a adjunct to the pressure dressing. But still, a difficult, spot to control bleeding depending on how high the wound is.

Those are our 3 sites that we may go directly or very quickly to hemostatics. Extremities we tourniquet. The bleeding from torso injuries "in general" is internal and not compressible and we don't address it other than dressings and Ashermans if its thoracic. There are other instances that we use hemostatics, but that is beyond the scope of what we are talking about here and is more of a remote/austere prolonged evac setting.

A couple more notes about Hemostatic agents, I've used all of them except woundstat. They all work about equally well, the low temp QuickClot doesnt scorch wounds anymore, and they are all easy to remove afterward. The biggest single factor in getting control of bleeding is using whatever agent correctly.

Get heavy pressure on the wound quickly, we teach kneeling on it if thats possible, or putting a gloved fist onto it with much of your body weight, get out your supplies, or take the downed officers IFAK off and use his, open up at least one, preferably two battle dressings, and the hemostatic agent (we use QuickClot ACS). Release pressure and immediately sweep the wound to clear excess blood, place the hemostatic agent as deep into the wound as possible to get to the bleedng vessels, put a battle dressing back onto / into the wound and put the same heavy pressure back onto the wound for 2 minutes. If the wound is deep you may need the additional dressing to build up enough so that the pressure you are applying at the top of the wound is transmitted all the way down to the base of the wound.

While the tourniquet info is geared more toward a care under fire setting, the hemostatic take home points are valid for .civ ems or TEMS/Military.

Additionally we are looking at CombatGuaze for scalp lacs/avulsions.

[Joe_Friday]

Hey Rob,
I have just a couple of questions that may help to answer your question and I should have asked before posting, being I made the original reply pretty generic.

1. What is the intended purpose? You alone, you and another, or more than two individuals.

2. Will you be depending on applying the kit to yourself or directing another to do so?

3. How far in minutes will you be from defined care if an incident were to occur? (estimate, I know you are never sure)

4. Is this going to be on your "GoTo" Rig or are you going to keep these items for the range mainly?

I know some of these questions may seem to be a moot point but it really helps to know as everyones situation may be different. As Iraqgunz said "everything is situation dependant." Do you know what the local EMS/trauma facility protocol is on using an hemostatic agent. I know that you live in a heavily populated area from your other posts but if you went to Podunk General because it is the nearest facility they may not have a clue what QuikClot or Woundstat is which could exacerbate the problem with Roscoe poking at it with a stick (trust me I have been to a few Podunk Generals before). Just something to think about. Of course as others have said, if your fixin' to be DRT who cares what anyone else thinks, pour it in and pray.

Oh and the tourniquet, I did not say anything about the amputations because Ray Charles can even see that you need to put a tourniquet on an amputation. Basically there will not be any tissue to save anyway.

To be honest with you, I have a little problem with the IFAK kits that I see a lot of people running around with anyway . The HSLD crowd has a definite need for some of these items but they have also been given the appropriate level of training as to when and, more importantly, when not to use certain items. While I agree that you should do everything you can to save someone, especially if it is numero uno, many do not understand that what they are doing is causing even more harm.

YMMV