Management of External Hemorrhage in Tactical Combat Casualty Care: Chitosan-Based Hemostatic Gauze Dressings TCCC Guidelines – Change 13-05
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Management of External Hemorrhage in Tactical Combat Casualty Care: Chitosan-Based Hemostatic Gauze Dressings TCCC Guidelines – Change 13-05 Brad L. Bennett, PhD, NREMT-P; Lanny F. Littlejohn, MD; Bijan S. Kheirabadi, PhD; Frank K. Butler, MD; Russ S. Kotwal, MD; Michael A. Dubick, PhD; Jeffrey A. Bailey, MD ABSTRACT Hemorrhage remains the leading cause of combat death KEYWORDS: hemorrhage, hemostasis, hemostatic agents, and a major cause of death from potentially survivable topical, dressing, bandage injuries. Great strides have been made in controlling extremity hemorrhage with tourniquets, but not all in- juries are amenable to tourniquet application. Topical hemostatic agents and dressings have also contributed Proximate Cause for the Proposed Change to success in controlling extremity and compressible junctional hemorrhage, and their efficacy continues 1. Since April 2008, no formal change proposal has to increase as enhanced products are developed. Since been made to include additional hemostatic dress- the addition of Combat Gauze™ (Z-Medica Corpora- ings to the guidelines, even though some of these tion, Wallingford, CT, USA; http://www.z-medica.com/) have experimental evidence showing equal or greater in April 2008 to the Tactical Combat Casualty Care efficacy than Combat Gauze and without reported (TCCC) Guidelines, there are consistent data from ani- complications. mal studies of severe hemorrhage that chitosan-based 2. There are consistent data now from animal models hemostatic gauze dressings developed for battlefield of severe hemorrhage that chitosan-based hemostatic application are, at least, equally efficacious as Com- gauze dressings developed for battlefield application bat Gauze. Successful outcomes are also reported using are, at least, equally efficacious as Combat Gauze. newer chitosan-based dressings in civilian hospital- There are eight reports1–8 of the equivalence of chi- based surgical case reports and prehospital (battlefield) tosan-based gauze dressings with Combat Gauze in case reports and series. Additionally, there have been no extremity arterial hemorrhage models (Celox Gauze; noted complications or safety concerns in these cases or ChitoGauze Celox RAPID; Celox Trauma Gauze; across many years of chitosan-based hemostatic dress- TraumaStat™ [Salem, OR, USA; http://www.oremedix ing use in both the military and civilian prehospital sec- .com/products/traumastat.asp]; mini-sponge dressing). tors. Consequently, after a decade of clinical use, there 3. Combat Gauze was selected for addition to the TCCC is added benefit and a good safety record for using chi- Guidelines since it was reported in two Department of tosan-based gauze dressings. For these reasons, many Defense (DoD) laboratories to be efficacious in a non- specific US military Special Operations Forces, NATO coagulopathic animal model. However, other animal militaries, and emergency medical services (EMS) and studies and clinical case reports show inconsistencies law enforcement agencies have already implemented the with Combat Gauze as well as poor efficacy in coag- widespread use of these new recommended chitosan- ulopathy-induced animals.9,10 In a case series (N = 19) based hemostatic dressings. Based on the past battlefield of combat casualties, seven patients were treated with success, this report proposes to keep Combat Gauze as Combat Gauze (two of seven were coagulopathic) in the hemostatic dressing of choice along with the new the prehospital setting, which then had to be removed addition of Celox™ Gauze (Medtrade Products Ltd., in the operating room and replaced with another he- Crewe, UK; http://www.celoxmedical.com/usa/products mostatic bandage to gain hemorrhage control.11 How- /celox-gauze/) and ChitoGauze® (HemCon Medical Tech- ever, more recently, Combat Gauze has demonstrated nologies, Portland, OR, USA; http://www.hemcon.com/) good efficacy in other coagulopathic animal studies to the TCCC Guidelines. compared with standard gauze.12,13 12 4. To date, there is no single hemostatic agent or dress- US Special Operations Command have led to the more ing that has all the ideal characteristics for battlefield ubiquitous distribution and use of hemorrhage control trauma.14–16 Because 38% of all combat casualties re- interventions by prehospital first responders. Great quiring blood transfusion are coagulopathic,17 there strides have been made in controlling extremity hem- is a need for an enhanced hemostatic dressing, such orrhage with tourniquets.34–36 Topical hemostatic agents as chitosan-based dressings or fibrin dressing, that (i.e., granules, powders) and dressings (i.e., an agent in- can stop bleeding independently of host coagulation corporated into gauze or bandage) have also contributed status.14 Fibrin dressings are efficacious, but they are to success in controlling extremity and compressible not cost-effective for the individual first responder junctional hemorrhage, and their efficacy continues to to carry, and they are better suited for surgical increase as enhanced products are developed.14–16,37–40 application.11,18 Even with these recent advances, there remain require- 5. In contrast, chitosan-based dressings work indepen- ments for ongoing research and development of hem- dently of host clotting pathways and consistently are orrhage control dressings and devices in an effort to reported to be efficacious in coagulopathic conditions continue to decrease the potentially survivable mortality (hypothermia or heparin) using animal models.19–24 rate (~24%) in Operational Forces33 to the 0% to 3% 6. Successful outcomes are also reported using newer level successfully demonstrated by the US Army 75th chitosan-based dressings (Celox Gauze) in civilian Ranger Regiment.41 hospital-based (surgical) case reports25–27 and prehos- pital (battlefield) case reports and series.28,29 Addition- The collective studies on the first-generation of hemo- ally, there have been no noted complications or safety static agents were essential for the Committee on Tacti- concerns in these cases or across many years of chi- cal Combat Casualty Care (CoTCCC) to examine the tosan-based hemostatic dressing use (HemCon® Ban- evidence-based research and make decisions for select- dage [HemCon Medical Technologies; http://www ing HemCon Bandage as the first hemostatic agent in .hemcon.com/products/] and Celox granules) in both 2003 and QuickClot® granules (Z-Medica Corpora- the military30,31 and civilian32 prehospital sectors. tion; http://www.z-medica.com/) as a backup agent in 7. Because of the long-term history of chitosan use and the 2006 TCCC Guidelines.42 Subsequently, a number safety in animal, prehospital, and surgical settings with- of second-generation hemostatic agents and dressings out complications, chitosan-based dressings have been were tested at both the US Army Institute of Surgical adopted for use (either carried with Combat Gauze Research and the Naval Medical Research Center. Both or carried as the only dressing) in specific US Special DoD laboratories reported that Combat Gauze, Wound- Operations Forces, the U.K. Ministry of Defense, and Stat (Traumacure, Inc., Bethesda, MD, USA; http://www at least eight other NATO militaries (Celox Gauze .TraumaCure.com.), and Celox were consistently more and Celox RAPID); the Medical College of Georgia effective than the previously selected first-generation he- hospital emergency department (ChitoGauze); the mostatic agents.43–46 Consequently, the CoTCCC voted California Emergency Medical Service Authority (Ce- (April 2008) to recommend Combat Gauze dressing as lox Gauze, Celox RAPID, HemCon ChitoFlex along the first-line treatment for life-threatening hemorrhage with Combat Gauze); and numerous US elite tactical from wounds not amenable to tourniquet placement. federal, state, city, and county law enforcement teams WoundStat was recommended as the backup agent (Celox Gauze, Celox RAPID, ChitoGauze). because combat medical personnel expressed a strong 8. For the same benefit, medics have multiple options preference for a gauze-type hemostatic dressing rather to manage battlefield trauma (e.g., airway devices than a granule for application.47 However, based on and pain medications, etc.); specific chitosan-based subsequent animal safety studies, WoundStat was later dressings should be made available to medics and removed from the TCCC Guidelines.48 first responders as another option to control severe bleeding in the domain of risk versus benefit. Topical hemostats are classified most commonly by mechanism of action into three types: factor concentra- tors, procoagulants, and mucoadhesives.15 Factor con- Background centrators adsorb water from blood and concentrate the Although aggressive control of external hemorrhage in clotting factors present (QuikClot granules). Procoagu- the prehospital environment has had a considerable im- lants either activate the clotting cascade (Combat Gauze) pact on morbidity and mortality during recent conflicts or provide clotting factors such as fibrinogen and/or in Afghanistan and Iraq, hemorrhage remains the lead- thrombin (dry fibrin sealant dressing). Mucoadhesives ing cause of combat death and a major cause of death are primarily chitosan based and work by cross-linking from potentially survivable injuries.33 Joint efforts from cellular blood components to form a mucoadhesive bar- the Naval Medical Research Center, the US Army Insti- rier (HemCon Bandage, ChitoGauze, Celox Gauze). tute of Surgical Research, US Central Command, and Some hemostatic