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TACTICAL COMBAT CASUALTY CARE: TRANSITIONING BATTLEFIELD LESSONS LEARNED TO OTHER AUSTERE ENVIRONMENTS| Volume 28, ISSUE 2, SUPPLEMENT , S39-S49, June 2017

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Bleeding Control Using Hemostatic Dressings: Lessons Learned

Published:March 18, 2017DOI:https://doi.org/10.1016/j.wem.2016.12.005
      Based on lessons learned, many military battlefield trauma advances ultimately transition to enhance civilian trauma care. However, even with major strides to enhance battlefield hemorrhage control, it is unclear how effectively these techniques and products are being translated to civilian trauma. The purpose of this brief review is to present the evidence of current hemostatic product effectiveness, determine the evidence for transitioning of this technology to prehospital civilian application, and provide recommendations about potential use in the wilderness/austere setting. It is concluded that there is adequate evidence of hemorrhage control effectiveness in both military and civilian preclinical studies and clinical case series. The Committee on Tactical Combat Casualty Care recommends implementing approved hemostatic dressings as one part of a comprehensive hemorrhage control training and clinical management program. These recommendations for hemostatic dressings use by public safety and laypersons should be applied in acute transport urban settings or during prolonged care in austere environments.

      Keywords

      Introduction

      Many historical advances in prehospital and operative care have occurred during wars and conflicts, with additional benefits when military lessons learned are transitioned to civilian medicine.
      • Pruitt Jr, B.A.
      The symbiosis of combat casualty care and civilian trauma care: 1914-2007.
      • Haider A.H.
      • Piper L.C.
      • Zogg C.K.
      • et al.
      Military-to-civilian translation of battlefield innovations in operative trauma care.
      Since the beginning of the Afghanistan and Iraq military conflicts in 2001, many medical advances in military trauma care have been made to decrease morbidity and mortality based on more than 52,000 US combat casualties. Many of these clinical advances are being transitioned into the civilian sector—for example, external and internal hemorrhage control, coagulopathy, acidosis, and blood component therapy.
      • Eastridge B.J.
      • Mabry R.L.
      • Seguin P.
      • et al.
      Death on the battlefield (2001-2011): implications for the future of combat casualty care.
      Despite these recent advances, hemorrhage remains the leading cause of combat death and is the second leading cause of death after traumatic brain injury in the civilian sector.
      • Eastridge B.J.
      • Mabry R.L.
      • Seguin P.
      • et al.
      Death on the battlefield (2001-2011): implications for the future of combat casualty care.
      • Valdez C.
      • Sarani B.
      • Young H.
      • Amdur R.
      • Dunne J.
      • Chawla L.S.
      Timing of death after traumatic injury−a contemporary assessment of the temporal distribution of death.
      • Sobrino J.
      • Shafi S.
      Timing and causes of death after injuries.
      Consequently, a vast amount of hemorrhage control research and development over the past 15 years has focused on controlling extremity hemorrhage because these wounds are potentially survivable.
      • Eastridge B.J.
      • Mabry R.L.
      • Seguin P.
      • et al.
      Death on the battlefield (2001-2011): implications for the future of combat casualty care.
      Even civilian trauma epidemiology studies have concluded that early trauma deaths (from immediately on scene to 24 hours after) due to hemorrhage are regarded as potentially survivable, but only if adequate personnel and resources are immediately available.
      • Valdez C.
      • Sarani B.
      • Young H.
      • Amdur R.
      • Dunne J.
      • Chawla L.S.
      Timing of death after traumatic injury−a contemporary assessment of the temporal distribution of death.
      Research and development on topical hemostatic agents has rapidly expanded since 2000, and the majority of evidence supports their utility over plain gauze to control severe hemorrhage. In addition, great strides have been made in trauma-related awareness and education and training of all military personnel in the appropriate use of tourniquets and hemostatic dressings to control severe bleeding and prevent shock and death.
      • Butler F.K.
      • Blackbourne L.H.
      Battlefield trauma care then and now: a decade of Tactical Combat Causality Care.
      • Butler F.K.
      • Smith D.J.
      • Carmona R.H.
      Implementing and preserving the advances in combat casualty care from Iraq and Afghanistan throughout the US Military.
      Hemostatic dressings are a valuable adjunct in external hemorrhage control when the source of bleeding is a location not amenable to tourniquet placement, such as in junctional regions (ie, neck, axilla, and groin).
      Consequently, hemostatic agents and dressings have been implemented into Tactical Combat Casualty Care (TCCC) Guidelines since 2003. Hemostatic dressings are only one item, along with pressure dressings, tourniquets, chest seals, and so forth, contained in the military individual first aid kit.
      • Butler F.K.
      • Holcomb J.B.
      • Giebner S.G.
      • McSwain N.E.
      • Bagian J.
      Tactical combat casualty care 2007: evolving concepts and battlefield experience.
      See Table 1 for an overview of first, second, and third generations of these approved hemostatic products. These products have contributed to the success in controlling extremity and compressible junctional hemorrhage in US and North Atlantic Treaty Organization military personnel.
      • Butler F.K.
      Military history of increasing survival: the US military experience with tourniquets and hemostatic dressings in the Afghanistan and Iraq conflicts.
      • Holcomb J.B.
      • Butler F.K.
      • Rhee P.
      Hemorrhage control devices: tourniquets and hemostatic dressings.
      Over the past decade, a number of reviews by authors from the United States and United Kingdom give greater detail on hemostatic agents and dressings used on the battlefield.
      • Kheirabadi B.S.
      Evaluation of topical hemostatic agents for combat wound treatment.
      • Gordy S.D.
      • Rhee P.
      • Schreiber M.A.
      Military applications of novel hemostatic devices.
      • Granville-Chapman J.
      • Jacobs N.
      • Midwinter M.J.
      Pre-hospital haemostatic dressings: a systematic review.
      • Smith A.H.
      • Liard C.
      • Porter K.
      • Bloch M.
      Hemostatic dressings in prehospital care.
      • Bennett B.L.
      • Littlejohn L.
      Review of third generation topical hemostatic agents for combat casualty care.
      • Bennett B.L.
      • Littlejohn L.F.
      • Kheirabadi B.S.
      • et al.
      Management of external hemorrhage in tactical combat casualty care: chitosan-based hemostatic gauze dressings—TCCC guidelines–Change 13–05.
      • Butler F.K.
      Military history of increasing survival: the US military experience with tourniquets and hemostatic dressings in the Afghanistan and Iraq conflicts.
      • Holcomb J.B.
      • Butler F.K.
      • Rhee P.
      Hemorrhage control devices: tourniquets and hemostatic dressings.
      • Mawhinney A.C.
      • Kirk S.J.
      A systematic review of the use of tourniquets and topical haemostatic agents in conflicts in Afghanistan and Iraq.
      Table 1First-, second-, and third-generation hemostatic products CoTCCC approved for battlefield use
      ManufacturerGenerationMechanism of actionFormApplication
      HemCon bandage, HemCon Medical Technologies, Portland, OR1stCross links RBCs to form mucoadhesive barrier4 × 4 inch wafer; 2 × 2 inch single-sided waferPlaced firmly over wound, 3 min direct pressure
      QuickClot granules, Z-Medica, Wallingford, CT1stRapidly adsorbs water in an exothermic reaction to concentrate clotting factorsGranular zeolite (volcanic rock)Pour deep into wound, pack standard gauze on top of granules, 3 min direct pressure
      QuikClot combat gauze, Z-Medica, Wallingford, CT2ndContact between kaolin and blood immediately initiates the clotting process by activating factor XII of the clotting cascadeGauze impregnated with kaolin, an inorganic mineralQuikClot comes in a variety of forms, including 4 × 4 dressings, trauma pads, rolled dressings, and Z-folded dressings
      Celox gauze, MedTrade Products Ltd, Crew, United Kingdom3rdCross-links RBCs to form mucoadhesive barrierChitosan rolled gauze Z-fold, 3 in × 10 ftPacked into wound, 3 min direct pressure
      ChitoGauze Pro, HemCon Medical Technologies, Portland, OR3rdCross-links RBCs to form mucoadhesive barrierChitosan gauze Z-fold, 12 ft lengthPacked into wound, 2–5 min direct pressure
      XStat, RevMedx Inc, Wilsonville, OR3rdCellulose sponges coated with chitosan to assist with a mucoadhesive barrier92 flat, circular, compressed mini sponges packaged in a 60-mL syringe applicatorThe applicator has a small diameter insertion device available for use in wounds with narrow wound tracts
      RBCs, red blood cells.
      As hemostatic product efficacy continues to evolve, there is limited information about how widespread combat casualty lessons learned for hemostatic dressings are disseminated in the civilian sector.
      • Bennett B.L.
      • Littlejohn L.
      Review of third generation topical hemostatic agents for combat casualty care.
      Thus, the purpose of this brief review is 1) to present the evidence of current hemostatic product effectiveness; 2) to determine the evidence for transitioning of this technology to prehospital civilian application; and 3) to provide recommendations about potential use in the wilderness/austere setting.

      Mechanism of Injury (Combat/Civilian/Wilderness)

      Traditional mechanisms of wounding historically have been different in combat and civilian settings. However, it should be appreciated that more than 53,000 civilians and military personnel were killed or injured by improvised explosive devices (IED) worldwide between 2011 and 2013. Trauma from penetrating fragmentation from explosive devices is becoming more common in developed countries, similar to what occurred in recent IED blasts in the civilian sectors (eg, at the Boston Marathon in 2014, in Paris in 2015, and elsewhere).
      • Elster E.A.
      • Butler F.K.
      • Rasmussen T.E.
      Implications of combat casualty care for mass casualty events.
      However, the best evidence from battlefield lessons learned regarding hemorrhage control should be applied similarly regardless of casualty incident location, barring any limitations on resources.
      For the last 13 years of combat casualty care in Afghanistan and Iraq, the mechanism of injury has been penetrating in approximately 75% of casualties. The majority of these injuries are principally caused by fragmentation from IEDs (~74%), followed by gunshot wounds (~22%) and blunt trauma (~4%).
      • Eastridge B.J.
      • Mabry R.L.
      • Seguin P.
      • et al.
      Death on the battlefield (2001-2011): implications for the future of combat casualty care.
      Most combat deaths occur before the patient ever reaches a surgical team. The leading cause of mortality is hemorrhage (91%) from 3 key anatomic regions: truncal (67%), junctional (19%), and extremity (13%).
      • Butler F.K.
      • Blackbourne L.H.
      Battlefield trauma care then and now: a decade of Tactical Combat Causality Care.
      • Butler F.K.
      • Smith D.J.
      • Carmona R.H.
      Implementing and preserving the advances in combat casualty care from Iraq and Afghanistan throughout the US Military.
      In the civilian sector, the primary mechanism of injury resulting in morbidity and mortality is blunt trauma (78–89%), followed by penetrating trauma (11–22%). The proportion of the immediate to early deaths (50–60%) from either cause has remained unchanged, and death is primarily the result of traumatic brain injury or hemorrhage. Historically, these findings have been consistent over many decades.
      • Valdez C.
      • Sarani B.
      • Young H.
      • Amdur R.
      • Dunne J.
      • Chawla L.S.
      Timing of death after traumatic injury−a contemporary assessment of the temporal distribution of death.
      • Sobrino J.
      • Shafi S.
      Timing and causes of death after injuries.
      • Acosta J.A.
      • Yang J.C.
      • Winchell R.J.
      • et al.
      Lethal injuries and time to death in a level one trauma center.
      • Sauaia A.
      • Moore F.A.
      • Moore E.E.
      • et al.
      Epidemiology of trauma deaths: a reassessment.
      However, in the wilderness setting, traumatic brain injury or multisystem trauma is the leading causes of morbidity and mortality for victims falling from height.
      • McLennan J.G.
      • Ungersma J.
      Mountaineering accidents in the Serria Nevada.
      • Stephens B.D.
      • Diekema D.S.
      • Klein E.J.
      Recreational injuries in Washington State National Parks.
      • Flores A.H.
      • Haileyesus T.
      • Greenspan A.I.
      National estimates of outdoor recreational injuries treated in emergency departments, United States, 2004-2005.
      • Windsor J.S.
      • Firth P.G.
      • Grocott M.P.
      Mountain mortality: a review of deaths that occur during recreational activities in the mountains.
      • Schöffl V.
      • Morrison A.
      • Schöffl I.
      • et al.
      The epidemiology of injury in mountaineering, rock and ice climbing.

      The Evolution (2003–2016) and Effectiveness of Hemostatic Agents/Dressings

      The history of the use by the Department of Defense of hemostatic agents and dressings for controlling major bleeding is presented by a several authors.
      • Bennett B.L.
      • Littlejohn L.
      Review of third generation topical hemostatic agents for combat casualty care.
      • Bennett B.L.
      • Littlejohn L.F.
      • Kheirabadi B.S.
      • et al.
      Management of external hemorrhage in tactical combat casualty care: chitosan-based hemostatic gauze dressings—TCCC guidelines–Change 13–05.
      • Butler F.K.
      Tactical combat casualty care: update 2009.
      • Butler F.K.
      • Hagmann J.
      • Butler E.G.
      Tactical combat casualty care in special operations.
      In brief, the initial 1996 TCCC Guidelines had no US Food and Drug Administration (FDA)-approved hemostatic agents applicable to battlefield (prehospital) care.
      • Butler F.K.
      Tactical combat casualty care: update 2009.
      In subsequent hemostatic agent research, the objective was to develop an effective product to control major bleeding within minutes that was safe for the casualty and medic; easy to apply by medics or infantryman; lightweight, durable, and with a long shelf life; and inexpensive.
      • Pusateri A.E.
      • Holcomb J.B.
      • Kheirabadi B.S.
      • Alam H.B.
      • Wade C.E.
      • Ryan K.L.
      Making sense of the preclinical literature on advanced hemostatic products.
      Eventually, by the 2003 TCCC guideline revision, a number of hemostatic products were reported to be efficacious to control massive bleeding in animal models.
      • Alam H.B.
      • Uy G.B.
      • Miller D.
      • et al.
      Comparative analysis of hemostatic agents in a swine model of lethal groin injury.
      • Alam H.B.
      • Chen Z.
      • Jaskille A.
      • et al.
      Application of a zeolite hemostatic agent achieves 100% survival in a lethal model of complex groin injury in swine.
      • Sondeen J.L.
      • Pusateri A.E.
      • Coppes V.G.
      • Gaddy C.E.
      • Holcomb J.B.
      Comparison of 10 different hemostatic dressings in an aortic injury.
      • Pusateri A.E.
      • Modrow H.E.
      • Harris R.A.
      • et al.
      Advanced hemostatic dressing development program: animal model selection criteria and results of a study of nine hemostatic dressings in a model of severe large venous hemorrhage and hepatic injury in Swine.
      • Pusateri A.E.
      • Delgado A.V.
      • Dick Jr, E.J.
      • Martinez R.S.
      • Holcomb J.B.
      • Ryan K.L.
      Application of a granular mineral-based hemostatic agent (QuikClot) to reduce blood loss after grade V liver injury in swine.
      The 2 leading agents selected for use on battlefield casualties were the chitosan-based bandage HemCon (HemCon Medical Technologies, Portland, OR) and the zeolite powder QuikClot (Z-Medica, Wallingford, CT). Both products were deemed to be equally efficacious to control severe bleeding based on these initial preclinical studies, but no single agent was considered to be more advantageous at that time. However, based on reported observations by military surgical teams, first-, second-, and third-degree burns were observed in the surrounding tissues after use of QuikClot. A rapid exothermic reaction is produced when blood makes contact with QuikClot (zeolite) granules during application in soft tissue wounds and can result in burns.
      • Wright J.K.
      • Kalns J.
      • Wolf E.A.
      • et al.
      Thermal injury resulting from application of a granular mineral hemostatic agent.
      Due to the adverse side effects of QuikClot granules, the Committee on Tactical Combat Casualty Care (CoTCCC) decided to designate the HemCon bandage as the initial hemostatic agent of choice.
      • Butler F.K.
      • Holcomb J.B.
      • Giebner S.G.
      • McSwain N.E.
      • Bagian J.
      Tactical combat casualty care 2007: evolving concepts and battlefield experience.
      The CoTCCC conducted a review of the literature on hemostatic dressings for potential tactical medicine guideline revision. The CoTCCC received input from combat-experienced first responders and trauma surgeons in an effort to capture their experiences with both QuikClot and HemCon. In addition, a review of any new studies using animal models of efficacy was conducted. It should be noted that the CoTCCC did not select an obvious winner in terms of efficacy in the laboratory or effectiveness based on case reports or series. In the 2006 TCCC guideline revision, both HemCon bandages and QuikClot granules were recommended to be carried by all combatants on the battlefield, but QuikClot was to be used as a secondary agent if HemCon was not effective or was not available.
      • Pusateri A.E.
      • Holcomb J.B.
      • Kheirabadi B.S.
      • Alam H.B.
      • Wade C.E.
      • Ryan K.L.
      Making sense of the preclinical literature on advanced hemostatic products.
      After the 2006 TCCC guideline revision as published in the Prehospital Trauma Life Support manual, a series of new hemostatic agents/dressings were evaluated for efficacy at both the United States Army Institute of Surgical Research and at the Naval Medical Research Center. The results from both studies reported that 2 new agents/dressings, QuikClot Combat Gauze (Z-Medica) and WoundStat (TraumaCure, Bethesda, MD), were consistently more effective than the previously recommended TCCC agents (HemCon and QuikClot).
      • Arnaud F.
      • Teranishi K.
      • Tomori T.
      • Carr W.
      • McCarron R.
      Comparison of 10 hemostatic dressing in a groin puncture model in swine.
      • Kheirabadi B.S.
      • Scherer M.R.
      • Estep J.S.
      • Dubick M.A.
      • Holcomb J.B.
      Determination of efficacy of new hemostatic dressings in a model of extremity arterial hemorrhage in swine.
      Consequently, the CoTCCC voted to recommend QuikClot Combat Gauze as the first-line treatment for life-threatening hemorrhage that is not amenable to tourniquet placement. WoundStat was recommended as the backup agent.
      • Bennett B.L.
      • Littlejohn L.
      Review of third generation topical hemostatic agents for combat casualty care.
      The primary reason for this order of priority was that medics and corpsmen expressed their preference for a gauze-type hemostatic agent because powders or granule agents do not work well in wounds in which the bleeding vessel is at the bottom of a narrow wound tract or in windy battlefield environments.
      • Butler F.K.
      Tactical combat casualty care: update 2009.
      WoundStat, a granular agent, was later removed from the TCCC Guidelines as a backup agent to QuikClot Combat Gauze because of embolic, thrombotic, and tissue complications reported in subsequent animal testing.
      • Kheirabadi B.S.
      • Mace J.E.
      • Terazzas I.B.
      • et al.
      Safety evaluation of new hemostatic agents, smectite granules, and kaolin-coated gauze in a vascular injury wound model in swine.
      After April 2008 and until 2014, no formal review of newer hemostatic agents/dressings was conducted. New and consistent data from animal models of severe hemorrhage indicated that chitosan-based hemostatic gauze dressings developed for battlefield application are at least as effective as QuikClot Combat Gauze. Nine studies reported good efficacy and equivalence of chitosan-based gauze dressings with QuikClot Combat Gauze dressing in preclinical extremity arterial hemorrhage models,
      • Xie H.
      • Teach J.S.
      • Burke A.P.
      • Lucchesi L.D.
      • Wu P.C.
      • Sarao R.C.
      Laparoscopic repair of inferior vena caval injury using a chitosan-based hemostatic dressing.
      • Arnaud F.
      • Teranishi K.
      • Okada T.
      • et al.
      Comparison of QuikClot Combat Gauze and TraumaStat in two severe groin injury models.

      Hoggarth A., Hardy C., Lyon A. Testing a new gauze hemostat with reduced treatment time (abstract). Presented at the Advanced Technology Applications for Combat Casualty Care Conference 2011. Ft. Lauderdale, FL: ATACCC. Available at:http://www.celoxmedical.com/wp-content/uploads/Celox-Rapid-reduced-compression-time-poster.pdf. Accessed September 20, 2016.

      • Schwartz R.B.
      • Reynolds B.Z.
      • Shiver S.A.
      • et al.
      Comparison of two packable hemostatic Gauze dressings in a porcine hemorrhage model.
      • Mueller G.R.
      • Pineda T.J.
      • Xie H.X.
      • et al.
      A novel sponge-based wound stasis dressing to treat lethal noncompressible hemorrhage.
      • Rall J.M.
      • Cox J.M.
      • Songer A.G.
      • Cestero R.F.
      • Ross J.D.
      Comparison of novel hemostatic dressings with QuikClot combat gauze in a standardized swine model of uncontrolled hemorrhage.
      • Kunio N.
      • Riha G.M.
      • Watson K.M.
      • Differding J.A.
      • Schreiber M.A.
      • Watters J.M.
      Chitosan based hemostatic dressing is associated with decreased blood loss in a swine uncontrolled hemorrhage model.
      • Satterly S.
      • Nelson D.
      • Zwintscher N.
      • et al.
      Hemostasis in a noncompressible hemorrhage model: an end-user evaluation of hemostatic agents in a proximal arterial injury.
      • Conley S.P.
      • Littlejohn L.F.
      • Henao J.
      • DeVito S.S.
      • Zarow G.J.
      Control of junctional hemorrhage in a consensus swine model with hemostatic gauze products following minimal training.
      as concluded in a formal review.
      • Bennett B.L.
      • Littlejohn L.
      Review of third generation topical hemostatic agents for combat casualty care.
      Additional peer-reviewed studies report successful outcomes using newer chitosan-based dressings (Celox Gauze, MedTrade Products Ltd, Crew, UK) in civilian hospital-based case reports
      • Muzzi L.
      • Tommasino G.
      • Tucci E.
      • Neri E.
      Successful use of a military haemostatic agent in patients undergoing extracorporeal circulatory assistance and delayed sternal closure.
      • Schmid B.C.
      • Rezniczek G.A.
      • Rolf N.
      • Maul H.
      Postpartum hemorrhage: use of hemostatic combat gauze.
      • Schmid B.C.
      • Rezniczek G.A.
      • Rolf N.
      • Saade G.
      • Gebauer G.
      • Maul H.
      Uterine packing with chitosan-covered gauze for control of postpartum hemorrhage.
      and prehospital (battlefield) case reports and series.
      • Tan E.C.T.H.
      • Bleeker C.P.
      Field experience with a chitosan based haemostatic dressing.
      • Arul G.S.
      • Bowley D.M.
      • DiRusso S.
      The use of Celox gauze as an adjunct to pelvic packing in otherwise uncontrollable pelvic haemorrhage secondary to penetrating trauma.
      Furthermore, no complications or safety concerns have been noted in these cases or across many years of chitosan-based hemostatic dressing use (HemCon bandage and Celox granules) in either the military
      • Wedmore I.
      • McManus J.G.
      • Pusateri A.E.
      • Holcomb J.B.
      A special report on the chitosan-based hemostatic dressing: experience in current combat operations.
      • Pozza M.
      • Millner R.W.J.
      Celox (chitosan) for haemostasis in massive traumatic bleeding: experience in Afghanistan.
      or civilian prehospital sectors.
      • Brown M.A.
      • Daya M.R.
      • Worley J.A.
      Experience with chitosan dressings in a civilian EMS system.
      Based on the evidence-based literature review, the CoTCCC voted to add both Celox Gauze and ChitoGauze Pro (HemCon Medical Technologies, Portland, OR) to the TCCC Guidelines along with QuikClot Combat Gauze.
      • Bennett B.L.
      • Littlejohn L.
      Review of third generation topical hemostatic agents for combat casualty care.
      Because of its effectiveness and usability, QuikClot Combat Gauze has remained the primary hemostatic gauze of choice in the TCCC Guidelines since 2008.
      A new FDA-approved hemostatic product called XStat (RevMedx, Wilsonville, OR) was added to the CoTCCC Guidelines in 2015.
      • Sims K.
      • Montgomery H.R.
      • Dituro P.
      • Kheirabadi B.S.
      • Butler F.K.
      Management of external hemorrhage in Tactical Combat Casualty Care: the adjunctive use of XStat™ compressed hemostatic sponges: TCCC Guidelines Change 15-03.
      The evidence for its effectiveness is based on preclinical animal wound model studies and product ease of use.
      • Mueller G.R.
      • Pineda T.J.
      • Xie H.X.
      • et al.
      A novel sponge-based wound stasis dressing to treat lethal noncompressible hemorrhage.
      • Cestero R.F.
      • Song B.K.
      The effect of hemostatic dressings in a subclavian artery and vein transection porcine model.
      • Kragh J.F.
      • Aden J.K.
      Gauze vs XStat in wound packing for hemorrhage control.
      This unique product was developed to fill a gap in hemorrhage control in deep-tract or narrow-entrance wounds. This syringe device places nonabsorbable, expandable, hemostatic sponges designed for temporary internal use into junctional, noncompressible wounds, which are not amenable to tourniquet use to control bleeding. The mini sponges expand upon contact with blood to fill the wound cavity and provide a physical barrier and pressure that facilitates formation of a clot. The device consists of sterile, nonabsorbable, radiopaque; compressed sponges; and may include an applicator to facilitate delivery into a wound. It is a temporary device for up to 4 hours of use until surgical care is acquired. XStat is not indicated for use in the thorax, the abdomen, the retroperitoneal space, the sacral space above the inguinal ligament, or tissues above the clavicle. XStat is intended for use in the battlefield or civilian tactical medical environment for low- and high-velocity gunshot wounds. This device can be considered for use in wilderness medicine for accidents causing deep penetrations (eg, from wild animal attacks, during hunting with either a long rifle or bow and arrows, and other sources such as an ice axe penetration during self-rescue) and other causes of penetration from individuals falling from height.
      The initial XStat study
      • Mueller G.R.
      • Pineda T.J.
      • Xie H.X.
      • et al.
      A novel sponge-based wound stasis dressing to treat lethal noncompressible hemorrhage.
      reported testing this hemostatic device in a swine model of subclavian artery and vein bleeding created through a 4.5-cm wound. This model was selected because bleeding subclavian vessels are difficult to compress compared with the inguinal (junctional) area, which allows for more effective pressure when applying hemostatic gauze. There were 8 animals in the XStat study group and 8 in a control QuikClot Combat Gauze group. The mini sponges were applied within the 4-minute application time window. One QuikClot Combat Gauze and one Kerlix gauze were used to pack the wound in the control group. These dressings were applied with 3 minutes of direct pressure, as per the manufacturer’s directions. At 60 minutes, survival was 100% (8 of 8) in the XStat group and 37.5% (3 of 8) in the QuikClot Combat Gauze group.
      • Mueller G.R.
      • Pineda T.J.
      • Xie H.X.
      • et al.
      A novel sponge-based wound stasis dressing to treat lethal noncompressible hemorrhage.
      A more recent study conducted by researchers at the Naval Medical Research Unit, San Antonio, compared XStat with QuikClot Combat Gauze in a large animal model of subclavian bleeding. They reported that XStat was applied in less time than QuikClot Combat Gauze (31 seconds vs 65 seconds) and resulted in less blood loss during the application time. With XStat, they reported 100% survival in subclavian vascular injuries, a wounding pattern that has been observed to be highly lethal in trauma patients.
      • Cestero R.F.
      • Song B.K.
      The effect of hemostatic dressings in a subclavian artery and vein transection porcine model.

      Hemostatic Agent/Dressing Best Practices

      Among many commercially available hemostatic agents/dressings, only 3 are currently recommended for use. (See full TCCC Guidelines at http://www.naemt.org/education/TCCC/guidelines_curriculum.) The recommendation of these 3 hemostatic products is based on an extensive evidence-based review of the literature on hemostatic dressings that show equal effectiveness.
      • Bennett B.L.
      • Littlejohn L.
      Review of third generation topical hemostatic agents for combat casualty care.
      • Bennett B.L.
      • Littlejohn L.F.
      • Kheirabadi B.S.
      • et al.
      Management of external hemorrhage in tactical combat casualty care: chitosan-based hemostatic gauze dressings—TCCC guidelines–Change 13–05.
      However, based on the past battlefield duration of use since 2008 and reported good success, the CoTCCC recommends QuikClot Combat Gauze as the hemostatic dressing of choice and Celox Gauze and ChitoGauze Pro as alternative dressings when QuikClot Combat Gauze is not available. See Table 2 for the TCCC recommendations for management of severe bleeding.
      • Butler F.K.
      • Giebner S.D.
      • McSwain N.
      • Pons P.
      Prehospital Trauma Life Support Manual.
      Table 2TCCC Guidelines for the management of bleeding
      For full TCCC Guidelines, see http://www.naemt.org/education/TCCC/guidelines_curriculum.
      Assess for unrecognized hemorrhage and control all sources of bleeding. If not already done, use a CoTCCC-recommended limb tourniquet to control life-threatening external hemorrhage that is anatomically amenable to tourniquet use or for any traumatic amputation. Apply directly to the skin 2–3 inches above the wound. If bleeding is not controlled with the first tourniquet, apply a second tourniquet side by side with the first.
      For compressible hemorrhage not amenable to limb tourniquet use or as an adjunct to tourniquet removal, use QuikClot Combat Gauze as the CoTCCC hemostatic dressing of choice.
      Alternative hemostatic adjuncts:
      • -
        Celox Gauze or
      • -
        ChitoGauze or
      • -
        XStat (Best for deep, narrow-tract junctional wounds)
      • Hemostatic dressings should be applied with at least 3 minutes of direct pressure (optional for XStat). Each dressing works differently, so if one fails to control bleeding, it may be removed and a fresh dressing of the same type or a different type applied.
      • If the bleeding site is amenable to use of a junctional tourniquet, immediately apply a CoTCCC-recommended junctional tourniquet. Do not delay application of the junctional tourniquet once it is ready for use. Apply hemostatic dressings with direct pressure if a junctional tourniquet is not available or while the junctional tourniquet is being readied for use.
      • Reassess prior tourniquet application. Expose the wound and determine if a tourniquet is needed. If it is needed, replace any limb tourniquet placed over the uniform with one applied directly to the skin 2–3 inches above wound. Ensure that bleeding is stopped.
      • When possible, a distal pulse should be checked. If bleeding persists or a distal pulse is still present, consider additional tightening of the tourniquet or the use of a second tourniquet side by side with the first to eliminate both bleeding and the distal pulse.
      • Limb tourniquets and junctional tourniquets should be converted to hemostatic or pressure dressings as soon as possible if 3 criteria are met: the casualty is not in shock; it is possible to monitor the wound closely for bleeding; and the tourniquet is not being used to control bleeding from an amputated extremity. Every effort should be made to convert tourniquets in less than 2 hours if bleeding can be controlled with other means. Do not remove a tourniquet that has been in place more than 6 hours unless close monitoring and lab capability are available.
      • Expose and clearly mark all tourniquet sites with the time of tourniquet application. Use an indelible marker.

      Clinical Evidence for Civilian Application

      To date, many gaps remain in high-level evidence (ie, randomized prospective clinical studies) on the effectiveness of hemostatic agents/dressings in both military and civilian studies. The clinical evidence from past and present generations of TCCC-approved hemostatic agents/dressings comes from only 9 peer-reviewed military and civilian case reports and case series (Table 3).
      • Wedmore I.
      • McManus J.G.
      • Pusateri A.E.
      • Holcomb J.B.
      A special report on the chitosan-based hemostatic dressing: experience in current combat operations.
      • Brown M.A.
      • Daya M.R.
      • Worley J.A.
      Experience with chitosan dressings in a civilian EMS system.
      • Rhee P.
      • Brown C.
      • Martin M.
      • et al.
      QuikClot use in trauma for hemorrhage control: case series of 103 documented uses.
      • Ran Y.
      • Hadad E.
      • Daher S.
      • et al.
      QuikClot Combat Gauze use for hemorrhage control in military trauma: January 2009 Israel Defense Force experience in the Gaza Strip preliminary report of 14 cases.
      • Travers S.
      • Lefort H.
      • Ramdani E.
      • et al.
      Hemostatic dressings in civil prehospital practice: 30 uses of QuikClot Combat Gauze.
      • Zietlow J.M.
      • Zietlow S.P.
      • Morris D.S.
      • Berns K.S.
      • Jenkins D.H.
      Prehospital use of hemostatic bandages and tourniquets: translation from military experience to implementation in civilian trauma care.
      • Shina A.
      • Lipsky A.M.
      • Nadler R.
      • et al.
      Prehospital use of hemostatic dressings by the Israel Defense Forces Medical Corps: a case series of 122 patients.
      • Te Grotenhuis R.
      • van Grunsven P.M.
      • Heutz W.M.
      • Tan E.C.
      Prehospital use of hemostatic dressings in emergency medical services in the Netherlands: a prospective study of 66 cases.
      • Leonard J.
      • Zietlow J.
      • Morris D.
      • et al.
      A multi-institutional study of hemostatic gauze and tourniquets in rural civilian trauma.
      • Bulger E.M.
      • Snyder D.
      • Schoelles K.
      • et al.
      An evidence-based prehospital guideline for external hemorrhage control: American College of Surgeons Committee on Trauma.
      Table 3Hemostatic agent and dressing peer-reviewed clinical case series, 2006–2016
      AuthorMilitary or civilianStudy type/ Hemostatic dressingSummary
      Leonard et al
      • Leonard J.
      • Zietlow J.
      • Morris D.
      • et al.
      A multi-institutional study of hemostatic gauze and tourniquets in rural civilian trauma.
      CivilianRestrospective case series; 2nd Gen QuikClot Combat GauzeNinety-five patients were managed by prehospital personnel with a hemostatic dressing and/or tourniquet. Forty received QuikClot Combat Gauze, 61 tourniquet, and 6 both products. The median age was 40 years; 29% were female. QuikClot Combat Gauze was 89% effective. Minimal morbidity was associated with QuikClot use. CAT was 98% effective. Median tourniquet time was 21 minutes (6–142), the median ISS was 9 (1–50), and mortality was 9.8%. QuikClot Combat Gauze is a safe and effective adjunct for hemorrhage control in rural civilian trauma across a wide range of injury patterns.
      Te Grotenhuis et al
      • Te Grotenhuis R.
      • van Grunsven P.M.
      • Heutz W.M.
      • Tan E.C.
      Prehospital use of hemostatic dressings in emergency medical services in the Netherlands: a prospective study of 66 cases.
      CivilianProspective case series; 3rd Gen ChitoGauzeLargest prospective study in civilian healthcare. Sixty-six patients were treated with ChitoGauze. Twenty-one patients were taking anticoagulants or had a clotting disorder. The injuries were located in the extremities (n = 29), the head and face (n = 29), or the neck, thorax, and groin (n = 8). ChitoGauze resulted in cessation of hemorrhage in 46/66 (70%) patients, ChitoGauze reduced hemorrhage in 13/66 (20%) patients and failed to control hemorrhage in 7/66 (10%) patients. No side effects have been observed during treatment. Authors demonstrated that ChitoGauze is an effective and safe adjunct in the prehospital treatment of massive hemorrhage.
      Zietlow et al
      • Zietlow J.M.
      • Zietlow S.P.
      • Morris D.S.
      • Berns K.S.
      • Jenkins D.H.
      Prehospital use of hemostatic bandages and tourniquets: translation from military experience to implementation in civilian trauma care.
      CivilianRetrospective case series study; 2nd Gen QuikClot Combat GauzeA total of 125 patients were treated with tourniquets and/or hemostatic gauze in the prehospital setting: 77 tourniquets were used for 73 patients and 62 hemostatic dressings were applied to 52 patients; 7 patients required both interventions. MOIs for hemostatic bandage use were blunt (50%) and penetrating (35%) trauma, and other MOIs (15%). Hemostatic bandage was applied to head and neck (50%), extremities (36%), and torso (14%); 95% success rate. Authors reported that civilian prehospital use of hemostatic gauze is feasible and effective at achieving hemostasis.
      Shina et al
      • Shina A.
      • Lipsky A.M.
      • Nadler R.
      • et al.
      Prehospital use of hemostatic dressings by the Israel Defense Forces Medical Corps: a case series of 122 patients.
      MilitaryRetrospective case series study; 2nd Gen QuikClot Combat GauzeIn the study, 122 patients had 133 hemostatic dressings applied. Injury mechanism was penetrating in 104 (85.2%), blunt in 4 (3.3%), and combined in 14 (11.5%) patients. Thirty-three dressings (27.8%) were used for junctional hemorrhage control (pelvis, shoulder, axilla, buttocks, groin, neck), and 92 dressings (72.1%) were placed in nonjunctional areas. Nonjunctional dressings included 63 (47.4%) applied to the extremities, 14 (10.5%) to the back and 4 (3%) to the head. Hemostatic dressing application was reported as successful in 88.6% (31/35) of junctional hemorrhage applications and in 91.9% (57/62) of extremity hemorrhage applications. Authors concluded that hemostatic dressings seem to be an effective tool for junctional hemorrhage control and should be considered as a second-line treatment for extremity hemorrhage control at the point of injury.
      Travers et al
      • Travers S.
      • Lefort H.
      • Ramdani E.
      • et al.
      Hemostatic dressings in civil prehospital practice: 30 uses of QuikClot Combat Gauze.
      CivilianProspective case series; 2nd Gen QuikClot Combat GauzePhysicians were asked to complete a specific questionnaire after each use of QuikClot Combat Gauze. Thirty hemostatic dressing uses were prospectively reported. The wounds were mostly caused by cold steel (n = 15) and were primarily cervicocephalic (n = 16), with 19/30 active arterial bleedings. For 26/30 uses, hemostatic dressing was justified by the lack of control from other hemostasis techniques; 30 applications were associated with 22 complete cessations of bleeding; 6 decreases of bleeding; and ineffectiveness in 2 cases. The application of QuikClot Combat Gauze permitted the removal of an effective tourniquet that was applied initially for 3 patients. No side effects were reported for QuikClot Combat Gauze. Authors conclude that the provision of hemostatic dressings in civilian resuscitation ambulances was useful in providing an additional tool to limit bleeding.
      Ran et al
      • Ran Y.
      • Hadad E.
      • Daher S.
      • et al.
      QuikClot Combat Gauze use for hemorrhage control in military trauma: January 2009 Israel Defense Force experience in the Gaza Strip preliminary report of 14 cases.
      MilitaryRetrospective case series; 2nd Gen QuikClot Combat GauzeFourteen uses were reported and reviewed (out of a total of 56 hemostatic interventions in 35 cases). Hemostatic dressings were applied to injuries to the head, neck, axilla, buttocks, abdomen, back, and pelvis in 10 cases, and to extremities in 4 cases. In 13 cases (93%) the injuries were caused by blast or gunshot mechanisms. The success rate was 79% (11/14). Failure to control hemorrhage was reported in 3 cases in 3 different locations: neck, buttock, and thigh. All failures were attributed to severe soft tissue and vascular injuries. No complications or adverse events were reported.
      Rhee et al
      • Rhee P.
      • Brown C.
      • Martin M.
      • et al.
      QuikClot use in trauma for hemorrhage control: case series of 103 documented uses.
      BothSelf-reporting survey; 1st Gen QuikClot granulesA total of 103 cases of QuikClot granule (1st Gen) use: 69 by the US military in Iraq, 20 by civilian trauma surgeons, and 14 by civilian first responders. There were 83 cases involving application to external wounds and 20 cases of intracorporeal use by military and civilian surgeons. All field applications by first responders were successful in controlling hemorrhage. The overall efficacy rate was 92%.
      Brown et al
      • Brown M.A.
      • Daya M.R.
      • Worley J.A.
      Experience with chitosan dressings in a civilian EMS system.
      CivilianRetrospective; 1st Gen HemCon bandageOf 37 uses, complete data were available for 34 cases. Wound location involved the head, neck, or face in 13 subjects and extremities in 18 subjects. One case each involved the chest, abdomen, and axilla. The bandage was effective in 27/34 (79%) cases, 25/34 (74%) within 3 min of application. In 25/34 cases, direct pressure had initially failed to control bleeding, and the HemCon Bandage was effective in 19/25 (76%). The HemCon Bandage failed to stop bleeding within 10 min in 7 cases. The HemCon Bandage is an effective adjunct for uncontrolled external hemorrhage when traditional measures, such as pressure and gauze dressings, fail.
      Wedmore et al
      • Wedmore I.
      • McManus J.G.
      • Pusateri A.E.
      • Holcomb J.B.
      A special report on the chitosan-based hemostatic dressing: experience in current combat operations.
      MilitaryRetrospective Survey of use; 1st Gen HemCon bandageSixty-four case uses of the HemCon dressing were reported and reviewed by 2 US Army physicians for a total of 64 combat uses. Dressings were used externally on the chest, groin, buttock, and abdomen in 25 cases; on extremities in 35 cases; and on neck or facial wounds in 4 cases. In 66% of cases, dressings were used after gauze failure and were 100% successful. In 62 (97%) of the cases, the use of the HemCon dressing resulted in cessation of bleeding or improvement in hemostasis.
      CAT, combat application tourniquet; ISS, injury severity score; MOIs, mechanisms of injury.
      The initial studies reporting clinical use of Gen 1 hemostatic agents published a case series using the HemCon bandage.
      • Wedmore I.
      • McManus J.G.
      • Pusateri A.E.
      • Holcomb J.B.
      A special report on the chitosan-based hemostatic dressing: experience in current combat operations.
      • Brown M.A.
      • Daya M.R.
      • Worley J.A.
      Experience with chitosan dressings in a civilian EMS system.
      They reported a 97% and 74% success rate in controlling hemorrhage, respectively. Rhee et al reported the largest case series on the original QuikClot granule Gen 1 product.
      • Rhee P.
      • Brown C.
      • Martin M.
      • et al.
      QuikClot use in trauma for hemorrhage control: case series of 103 documented uses.
      Of the 103 cases reported, 83 were external (vice intracorporeal), and all first responder uses were successful. They reported 92% efficacy with QuikClot granules with frequent complications of excessive heat and pain. The majority of the peer-reviewed case series are primarily with QuikClot Combat Gauze because this is the hemostatic gauze of choice since 2008. Two retrospective case series (n=14 cases) and (n = 122 cases) using QuikClot Combat Gauze in the Israel Defense Force personnel were based on multiple penetrating injuries caused by improvised explosive device or gunshot wounds in many anatomical regions per casualty.
      • Ran Y.
      • Hadad E.
      • Daher S.
      • et al.
      QuikClot Combat Gauze use for hemorrhage control in military trauma: January 2009 Israel Defense Force experience in the Gaza Strip preliminary report of 14 cases.
      • Shina A.
      • Lipsky A.M.
      • Nadler R.
      • et al.
      Prehospital use of hemostatic dressings by the Israel Defense Forces Medical Corps: a case series of 122 patients.
      They reported a range of 79% to 89% success rate to control hemorrhage, respectively.
      In addition, good effectiveness was recently reported using QuikClot Combat Gauze in the civilian sector in both the United States and the United Kingdom when applied to injuries caused by blunt and penetration mechanisms. In 3 civilian peer-reviewed case series with 30, 95, and 125 patients, authors reported success rates of 73%, 95%, and 89%, respectively, in controlling severe bleeding in their patients.
      • Travers S.
      • Lefort H.
      • Ramdani E.
      • et al.
      Hemostatic dressings in civil prehospital practice: 30 uses of QuikClot Combat Gauze.
      • Zietlow J.M.
      • Zietlow S.P.
      • Morris D.S.
      • Berns K.S.
      • Jenkins D.H.
      Prehospital use of hemostatic bandages and tourniquets: translation from military experience to implementation in civilian trauma care.
      • Leonard J.
      • Zietlow J.
      • Morris D.
      • et al.
      A multi-institutional study of hemostatic gauze and tourniquets in rural civilian trauma.
      The only peer-reviewed case series using HemCon ChitoGauze Pro is based on a 2.5-year prospective study using ambulance calls in 2 Netherland-based emergency medical services.
      • Te Grotenhuis R.
      • van Grunsven P.M.
      • Heutz W.M.
      • Tan E.C.
      Prehospital use of hemostatic dressings in emergency medical services in the Netherlands: a prospective study of 66 cases.
      They reported applying ChitoGauze dressing in 66 patients only after conventional treatment (gauze dressing with manual pressure) failed to control external traumatic bleeding or if conventional treatment was unlikely to achieve hemostasis based on injuries occurring in many different anatomical regions. ChitoGauze only failed to stop or minimize bleeding in 7 of 66 (10%) patients. They concluded that this is the largest prospective study of use of hemostatic dressings in civilian health care and the second largest case series in a prehospital setting; ChitoGauze was determined to be an effective and safe hemorrhage control adjunct in the prehospital.
      • Te Grotenhuis R.
      • van Grunsven P.M.
      • Heutz W.M.
      • Tan E.C.
      Prehospital use of hemostatic dressings in emergency medical services in the Netherlands: a prospective study of 66 cases.
      To date, other than studies on military casualties, there are no civilian peer-reveiwed studies reporting the use of Celox Gauze.

      Recommendation for Wilderness Medical Providers

      Based on military lessons learned from over a decade of success in controlling severe bleeding, there is good evidence, albeit limited data, from civilian studies to make recommendations for hemostatic dressing use in civilian emergency medical systems and austere environments. A recent noteworthy evidence-based review of hemorrhage control was put forth by the American College of Surgeons (ACS) Committee on Trauma, which advocates the use of tourniquets and hemostatic agents in the prehospital setting. See Table 4 for the 3 recommendations on hemostatic dressing use in the civilian sector.
      • Bulger E.M.
      • Snyder D.
      • Schoelles K.
      • et al.
      An evidence-based prehospital guideline for external hemorrhage control: American College of Surgeons Committee on Trauma.
      Table 4Evidence-based prehospital guideline recommendations for hemostatic dressings
      • Bulger E.M.
      • Snyder D.
      • Schoelles K.
      • et al.
      An evidence-based prehospital guideline for external hemorrhage control: American College of Surgeons Committee on Trauma.
      Topical hemostatic agents
      Recommendation 1
      We suggest the use of topical hemostatic agents, in combination with direct pressure, for the control of significant hemorrhage in the prehospital setting in anatomic areas where tourniquets cannot be applied and where sustained direct pressure alone is ineffective or impractical.
      Strength of Recommendation: Weak
      Quality of Evidence: Low
      Remarks: Although the evidence was low, data from animal models are consistent, suggesting reduced hemorrhage with these agents compared with standard gauze, and the committee believed that junctional hemorrhage and torso wounds may benefit from the combination of direct pressure and hemostatic dressings.
      Recommendation 2
      We suggest that topical hemostatic agents be delivered in a gauze format that supports wound packing.
      Strength of Recommendation: Weak
      Quality of Evidence: Low
      Remarks: This recommendation was based on military experience and animal studies suggesting that products that allow packing of the wound have superior hemorrhage control.
      Recommendation 3
      Only products determined effective and safe in a standardized laboratory injury model should be used.
      Strength of Recommendation: Weak
      Quality of Evidence: Low
      Remarks: The US Army Institute for Surgical Research has developed a standardized large animal model for comparison of hemostatic dressings. The committee believed that all new products should be subject to this testing.
      Hemostatic dressings are now recommended for civilian first aid,
      • Singletary E.M.
      • Charlton N.P.
      • Epstein J.L.
      • et al.
      Part 15: First aid: 2015 American Heart Association and American Red Cross guidelines update for first aid.
      emergency medical services personnel, civilian tactical medicine,
      • Callaway D.W.
      • Smith E.R.
      • Cain J.
      • et al.
      Tactical emergency casualty care (TECC): guidelines for the provision of prehospital trauma care in high threat environments.
      and in wilderness medicine,
      • Johnson D.E.
      • Schimelpfenig T.
      • Hubbell F.
      • et al.
      Minimum guidelines and scope of practice for wilderness first aid.
      as well as the new course called Stop the Bleed, as hosted by the National Association of Emergency Medical Technicians (see http://www.naemt.org/about_ems/stop-the-bleed-campaign). This new course was recently developed based on TCCC Guidelines following an active shooter incident at a Connecticut elementary school. This is a nationwide federal government–based effort to educate and train laypersons to manage severe bleeding caused by either home or industrial accidents, blunt trauma, active shooter incidences, and other mass casualties.
      • Butler F.K.
      Stop the bleed. Strategies to enhance survival in active shooter and intentional mass casualty events. The Hartford Consensus. A major step forward in translating battlefield trauma care advances to the civilian sector.
      • Pons P.T.
      • Jerome J.
      • McMullen J.
      • Manson J.
      • Robinson J.
      • Chapleau W.
      The Hartford Consensus on active shooters: implementing the continuum of prehospital trauma response.
      A hemorrhage control algorithm for backcountry use was previously published.
      • Pons P.T.
      • Jerome J.
      • McMullen J.
      • Manson J.
      • Robinson J.
      • Chapleau W.
      The Hartford Consensus on active shooters: implementing the continuum of prehospital trauma response.
      • Littlejohn L.
      • Bennett B.
      • Drew B.
      Application of current hemorrhage control techniques for backcountry care: part two, hemostatic dressings and other adjuncts.
      The following items are recommended for an individual hemorrhage control kit for use in austere environments: 2 rolls of gauze, 2 pressure dressings, 2 hemostatic dressings, and 2 tourniquets.
      • Littlejohn L.
      • Bennett B.
      • Drew B.
      Application of current hemorrhage control techniques for backcountry care: part two, hemostatic dressings and other adjuncts.
      Both hemostatic dressings and tourniquets should be the same commercial products approved for use by the CoTCCC.
      • Littlejohn L.
      • Bennett B.
      • Drew B.
      Application of current hemorrhage control techniques for backcountry care: part two, hemostatic dressings and other adjuncts.
      • Drew B.
      • Bennett B.
      • Littlejohn L.
      Application of current hemorrhage control techniques for backcountry care: part one, tourniquets and hemorrhage control adjuncts.

      Summary

      Hemostatic agents and dressings for managing hemorrhage on the battlefield have evolved since 2003. The focus has been on developing more effective and safe hemostatic products and, through enhanced training, how best to use them. The majority of hemostatic studies are preclinical animal models; clinical studies have been very limited until recently. Consequently, the quality of evidence has been rated low, and any recommendation of use has been considered weak. However, larger case series are now being reported worldwide in the civilian prehospital setting with fairly high levels of success in controlling severe bleeding. Consequently, an expert panel convened by the ACS Committee on Trauma now recommends using the currently approved CoTCCC hemostatic products in civilian settings. This includes not only urban but also austere environments, as one part of a comprehensive program for managing severe bleeding.
      Any program should begin with effective training, based on proven methods; in application of manual direct pressure; wound packing with plain gauze or hemostatic gauze; pressure dressing; and application of one or more tourniquets as needed. Future hemorrhage control research is needed in gap areas, including randomized control studies and ongoing evaluation of new products and devices for unique and challenging anatomical regions that are not amenable to tourniquet application (eg, groin, neck, face, scalp) and which can be equally used in military and civilian populations. Future technology will continue to yield innovations for controlling severe bleeding in austere or wilderness environments and will, in turn, prevent shock and death.
      Financial/Material Support: None.
      Disclosures: None.

      References

        • Pruitt Jr, B.A.
        The symbiosis of combat casualty care and civilian trauma care: 1914-2007.
        J Trauma Acute Care Surg. 2008; 64: S4-S8
        • Haider A.H.
        • Piper L.C.
        • Zogg C.K.
        • et al.
        Military-to-civilian translation of battlefield innovations in operative trauma care.
        Surgery. 2015; 158: 1686-1695
        • Eastridge B.J.
        • Mabry R.L.
        • Seguin P.
        • et al.
        Death on the battlefield (2001-2011): implications for the future of combat casualty care.
        J Trauma Acute Care Surg. 2012; 73: S431-S437
        • Butler F.K.
        • Blackbourne L.H.
        Battlefield trauma care then and now: a decade of Tactical Combat Causality Care.
        J Trauma Acute Care Surg. 2012; 73: S395-S402
        • Butler F.K.
        • Smith D.J.
        • Carmona R.H.
        Implementing and preserving the advances in combat casualty care from Iraq and Afghanistan throughout the US Military.
        J Trauma Acute Care Surg. 2015; 79: 321-326
        • Valdez C.
        • Sarani B.
        • Young H.
        • Amdur R.
        • Dunne J.
        • Chawla L.S.
        Timing of death after traumatic injury−a contemporary assessment of the temporal distribution of death.
        J Surg Res. 2016; 200: 604-609
        • Sobrino J.
        • Shafi S.
        Timing and causes of death after injuries.
        Proc (Bayl Univ Med Cent). 2013; 26: 120-123
        • Butler F.K.
        • Holcomb J.B.
        • Giebner S.G.
        • McSwain N.E.
        • Bagian J.
        Tactical combat casualty care 2007: evolving concepts and battlefield experience.
        Mil Med. 2007; 172: 1-19
        • Butler F.K.
        Military history of increasing survival: the US military experience with tourniquets and hemostatic dressings in the Afghanistan and Iraq conflicts.
        Bull Am Coll Surg. 2015; 100: 60-64
        • Holcomb J.B.
        • Butler F.K.
        • Rhee P.
        Hemorrhage control devices: tourniquets and hemostatic dressings.
        Bull Am Coll Surg. 2015; 100: 66-70
        • Kheirabadi B.S.
        Evaluation of topical hemostatic agents for combat wound treatment.
        US Army Med Dep J. 2011; 2: 25-37
        • Gordy S.D.
        • Rhee P.
        • Schreiber M.A.
        Military applications of novel hemostatic devices.
        Expert Rev Med Devices. 2011; 8: 41-47
        • Granville-Chapman J.
        • Jacobs N.
        • Midwinter M.J.
        Pre-hospital haemostatic dressings: a systematic review.
        Injury. 2011; 42: 447-459
        • Smith A.H.
        • Liard C.
        • Porter K.
        • Bloch M.
        Hemostatic dressings in prehospital care.
        Emerg Med J. 2013; 30: 784-789
        • Bennett B.L.
        • Littlejohn L.
        Review of third generation topical hemostatic agents for combat casualty care.
        Mil Med. 2014; 179: 497-514
        • Bennett B.L.
        • Littlejohn L.F.
        • Kheirabadi B.S.
        • et al.
        Management of external hemorrhage in tactical combat casualty care: chitosan-based hemostatic gauze dressings—TCCC guidelines–Change 13–05.
        J Spec Oper Med. 2014; 14: 40-45
        • Butler F.K.
        Military history of increasing survival: the US military experience with tourniquets and hemostatic dressings in the Afghanistan and Iraq conflicts.
        J Spec Oper Med. 2015; 15: 149-152
        • Holcomb J.B.
        • Butler F.K.
        • Rhee P.
        Hemorrhage control devices: tourniquets and hemostatic dressings.
        J Spec Oper Med. 2015; 15: 153-156
        • Mawhinney A.C.
        • Kirk S.J.
        A systematic review of the use of tourniquets and topical haemostatic agents in conflicts in Afghanistan and Iraq.
        J R Nav Med Serv. 2015; 101: 147-154
        • Elster E.A.
        • Butler F.K.
        • Rasmussen T.E.
        Implications of combat casualty care for mass casualty events.
        JAMA. 2013; 310: 475-476
        • Acosta J.A.
        • Yang J.C.
        • Winchell R.J.
        • et al.
        Lethal injuries and time to death in a level one trauma center.
        J Am Coll Surg. 1998; 186: 528-533
        • Sauaia A.
        • Moore F.A.
        • Moore E.E.
        • et al.
        Epidemiology of trauma deaths: a reassessment.
        J Trauma Acute Care Surg. 1995; 38: 185-193
        • McLennan J.G.
        • Ungersma J.
        Mountaineering accidents in the Serria Nevada.
        Am J Sports Med. 1983; 11: 160-163
        • Stephens B.D.
        • Diekema D.S.
        • Klein E.J.
        Recreational injuries in Washington State National Parks.
        Wilderness Environ Med. 2005; 16: 192-197
        • Flores A.H.
        • Haileyesus T.
        • Greenspan A.I.
        National estimates of outdoor recreational injuries treated in emergency departments, United States, 2004-2005.
        Wilderness Environ Med. 2008; 19: 91-98
        • Windsor J.S.
        • Firth P.G.
        • Grocott M.P.
        Mountain mortality: a review of deaths that occur during recreational activities in the mountains.
        Postgrad Med J. 2009; 85: 316-321
        • Schöffl V.
        • Morrison A.
        • Schöffl I.
        • et al.
        The epidemiology of injury in mountaineering, rock and ice climbing.
        Med Sports Sci. 2012; 58: 17-34
        • Butler F.K.
        Tactical combat casualty care: update 2009.
        J Trauma. 2010; 69: S10-S13
        • Butler F.K.
        • Hagmann J.
        • Butler E.G.
        Tactical combat casualty care in special operations.
        Mil Med. 1996; 161: 3-16
        • Pusateri A.E.
        • Holcomb J.B.
        • Kheirabadi B.S.
        • Alam H.B.
        • Wade C.E.
        • Ryan K.L.
        Making sense of the preclinical literature on advanced hemostatic products.
        J Trauma. 2006; 60: 674-682
        • Alam H.B.
        • Uy G.B.
        • Miller D.
        • et al.
        Comparative analysis of hemostatic agents in a swine model of lethal groin injury.
        J Trauma. 2003; 54: 1077-1082
        • Alam H.B.
        • Chen Z.
        • Jaskille A.
        • et al.
        Application of a zeolite hemostatic agent achieves 100% survival in a lethal model of complex groin injury in swine.
        J Trauma. 2004; 56: 974-983
        • Sondeen J.L.
        • Pusateri A.E.
        • Coppes V.G.
        • Gaddy C.E.
        • Holcomb J.B.
        Comparison of 10 different hemostatic dressings in an aortic injury.
        J Trauma. 2003; 54: 280-285
        • Pusateri A.E.
        • Modrow H.E.
        • Harris R.A.
        • et al.
        Advanced hemostatic dressing development program: animal model selection criteria and results of a study of nine hemostatic dressings in a model of severe large venous hemorrhage and hepatic injury in Swine.
        J Trauma. 2003; 55: 518-526
        • Pusateri A.E.
        • Delgado A.V.
        • Dick Jr, E.J.
        • Martinez R.S.
        • Holcomb J.B.
        • Ryan K.L.
        Application of a granular mineral-based hemostatic agent (QuikClot) to reduce blood loss after grade V liver injury in swine.
        J Trauma. 2004; 57: 555-562
        • Wright J.K.
        • Kalns J.
        • Wolf E.A.
        • et al.
        Thermal injury resulting from application of a granular mineral hemostatic agent.
        J Trauma. 2004; 57: 224-230
      1. McSwain N.E. Salome J.P. Prehospital Trauma Life Support Manual. 6th ed. Mosby, Akron, OH2006
        • Arnaud F.
        • Teranishi K.
        • Tomori T.
        • Carr W.
        • McCarron R.
        Comparison of 10 hemostatic dressing in a groin puncture model in swine.
        J Vasc Surg. 2009; 50: 632-639
        • Kheirabadi B.S.
        • Scherer M.R.
        • Estep J.S.
        • Dubick M.A.
        • Holcomb J.B.
        Determination of efficacy of new hemostatic dressings in a model of extremity arterial hemorrhage in swine.
        J Trauma. 2009; 67: 459-460
        • Kheirabadi B.S.
        • Mace J.E.
        • Terazzas I.B.
        • et al.
        Safety evaluation of new hemostatic agents, smectite granules, and kaolin-coated gauze in a vascular injury wound model in swine.
        J Trauma. 2010; 68: 269-278
        • Xie H.
        • Teach J.S.
        • Burke A.P.
        • Lucchesi L.D.
        • Wu P.C.
        • Sarao R.C.
        Laparoscopic repair of inferior vena caval injury using a chitosan-based hemostatic dressing.
        Am J Surg. 2009; 197: 510-514
        • Arnaud F.
        • Teranishi K.
        • Okada T.
        • et al.
        Comparison of QuikClot Combat Gauze and TraumaStat in two severe groin injury models.
        J Surg Res. 2011; 169: 92-98
      2. Hoggarth A., Hardy C., Lyon A. Testing a new gauze hemostat with reduced treatment time (abstract). Presented at the Advanced Technology Applications for Combat Casualty Care Conference 2011. Ft. Lauderdale, FL: ATACCC. Available at:http://www.celoxmedical.com/wp-content/uploads/Celox-Rapid-reduced-compression-time-poster.pdf. Accessed September 20, 2016.

        • Schwartz R.B.
        • Reynolds B.Z.
        • Shiver S.A.
        • et al.
        Comparison of two packable hemostatic Gauze dressings in a porcine hemorrhage model.
        Prehosp Emerg Care. 2011; 15: 477-482
        • Mueller G.R.
        • Pineda T.J.
        • Xie H.X.
        • et al.
        A novel sponge-based wound stasis dressing to treat lethal noncompressible hemorrhage.
        J Trauma Acute Care Surg. 2012; 73: S134-S139
        • Rall J.M.
        • Cox J.M.
        • Songer A.G.
        • Cestero R.F.
        • Ross J.D.
        Comparison of novel hemostatic dressings with QuikClot combat gauze in a standardized swine model of uncontrolled hemorrhage.
        J Trauma Acute Care Surg. 2013; 75: S150-S156
        • Kunio N.
        • Riha G.M.
        • Watson K.M.
        • Differding J.A.
        • Schreiber M.A.
        • Watters J.M.
        Chitosan based hemostatic dressing is associated with decreased blood loss in a swine uncontrolled hemorrhage model.
        Am J Surg. 2013; 205: 505-510
        • Satterly S.
        • Nelson D.
        • Zwintscher N.
        • et al.
        Hemostasis in a noncompressible hemorrhage model: an end-user evaluation of hemostatic agents in a proximal arterial injury.
        J Surg Educ. 2013; 70: 206-211
        • Conley S.P.
        • Littlejohn L.F.
        • Henao J.
        • DeVito S.S.
        • Zarow G.J.
        Control of junctional hemorrhage in a consensus swine model with hemostatic gauze products following minimal training.
        Mil Med. 2015; 180: 1189-1195
        • Muzzi L.
        • Tommasino G.
        • Tucci E.
        • Neri E.
        Successful use of a military haemostatic agent in patients undergoing extracorporeal circulatory assistance and delayed sternal closure.
        Interact Cardiovasc Thorac Surg. 2012; 14: 695-698
        • Schmid B.C.
        • Rezniczek G.A.
        • Rolf N.
        • Maul H.
        Postpartum hemorrhage: use of hemostatic combat gauze.
        Am J Obstet Gynecol. 2012; 206: e12-e13
        • Schmid B.C.
        • Rezniczek G.A.
        • Rolf N.
        • Saade G.
        • Gebauer G.
        • Maul H.
        Uterine packing with chitosan-covered gauze for control of postpartum hemorrhage.
        Am J Obstet Gynecol. 2013; 209: 225
        • Tan E.C.T.H.
        • Bleeker C.P.
        Field experience with a chitosan based haemostatic dressing.
        Med Corps Int Forum. 2011; 3: 11-15
        • Arul G.S.
        • Bowley D.M.
        • DiRusso S.
        The use of Celox gauze as an adjunct to pelvic packing in otherwise uncontrollable pelvic haemorrhage secondary to penetrating trauma.
        J R Army Med Corps. 2012; 158: 331-333
        • Wedmore I.
        • McManus J.G.
        • Pusateri A.E.
        • Holcomb J.B.
        A special report on the chitosan-based hemostatic dressing: experience in current combat operations.
        J Trauma. 2006; 60: 655-658
        • Pozza M.
        • Millner R.W.J.
        Celox (chitosan) for haemostasis in massive traumatic bleeding: experience in Afghanistan.
        Eur J Emerg Med. 2011; 18: 31-33
        • Brown M.A.
        • Daya M.R.
        • Worley J.A.
        Experience with chitosan dressings in a civilian EMS system.
        J Emerg Med. 2009; 37: 1-7
        • Sims K.
        • Montgomery H.R.
        • Dituro P.
        • Kheirabadi B.S.
        • Butler F.K.
        Management of external hemorrhage in Tactical Combat Casualty Care: the adjunctive use of XStat™ compressed hemostatic sponges: TCCC Guidelines Change 15-03.
        J Spec Oper Med. 2016; 16: 19-28
        • Cestero R.F.
        • Song B.K.
        The effect of hemostatic dressings in a subclavian artery and vein transection porcine model.
        Naval Medical Research Unit San Antonio Technical Report TR-2013-012. 2013;
        • Kragh J.F.
        • Aden J.K.
        Gauze vs XStat in wound packing for hemorrhage control.
        Am J Em Med. 2015; 33: 974-976
        • Butler F.K.
        • Giebner S.D.
        • McSwain N.
        • Pons P.
        Prehospital Trauma Life Support Manual.
        (Military Version). 8th ed. American College of Surgeons, Chicago, IL2014
        • Rhee P.
        • Brown C.
        • Martin M.
        • et al.
        QuikClot use in trauma for hemorrhage control: case series of 103 documented uses.
        J Trauma. 2008; 64: 1093-1099
        • Ran Y.
        • Hadad E.
        • Daher S.
        • et al.
        QuikClot Combat Gauze use for hemorrhage control in military trauma: January 2009 Israel Defense Force experience in the Gaza Strip preliminary report of 14 cases.
        Prehosp Disaster Med. 2010; 25: 584-588
        • Travers S.
        • Lefort H.
        • Ramdani E.
        • et al.
        Hemostatic dressings in civil prehospital practice: 30 uses of QuikClot Combat Gauze.
        Eur J Emerg Med. 2016; 23: 391-394
        • Zietlow J.M.
        • Zietlow S.P.
        • Morris D.S.
        • Berns K.S.
        • Jenkins D.H.
        Prehospital use of hemostatic bandages and tourniquets: translation from military experience to implementation in civilian trauma care.
        J Spec Oper Med. 2015; 15: 48-53
        • Shina A.
        • Lipsky A.M.
        • Nadler R.
        • et al.
        Prehospital use of hemostatic dressings by the Israel Defense Forces Medical Corps: a case series of 122 patients.
        J Trauma Acute Care Surg. 2015; 79: S204-S209
        • Te Grotenhuis R.
        • van Grunsven P.M.
        • Heutz W.M.
        • Tan E.C.
        Prehospital use of hemostatic dressings in emergency medical services in the Netherlands: a prospective study of 66 cases.
        Injury. 2016; 47: 1007-1011
        • Leonard J.
        • Zietlow J.
        • Morris D.
        • et al.
        A multi-institutional study of hemostatic gauze and tourniquets in rural civilian trauma.
        J Trauma Acute Care Surg. 2016; 81: 441-444
        • Bulger E.M.
        • Snyder D.
        • Schoelles K.
        • et al.
        An evidence-based prehospital guideline for external hemorrhage control: American College of Surgeons Committee on Trauma.
        Prehosp Emerg Care. 2014; 18: 163-173
        • Singletary E.M.
        • Charlton N.P.
        • Epstein J.L.
        • et al.
        Part 15: First aid: 2015 American Heart Association and American Red Cross guidelines update for first aid.
        Circulation. 2015; 132: S574-S589
        • Callaway D.W.
        • Smith E.R.
        • Cain J.
        • et al.
        Tactical emergency casualty care (TECC): guidelines for the provision of prehospital trauma care in high threat environments.
        J Spec Oper Med. 2011; 11: 104-122
        • Johnson D.E.
        • Schimelpfenig T.
        • Hubbell F.
        • et al.
        Minimum guidelines and scope of practice for wilderness first aid.
        Wilderness Environ Med. 2013; 24: 456-462
        • Butler F.K.
        Stop the bleed. Strategies to enhance survival in active shooter and intentional mass casualty events. The Hartford Consensus. A major step forward in translating battlefield trauma care advances to the civilian sector.
        J Spec Oper Med. 2015; 15: 133-135
        • Pons P.T.
        • Jerome J.
        • McMullen J.
        • Manson J.
        • Robinson J.
        • Chapleau W.
        The Hartford Consensus on active shooters: implementing the continuum of prehospital trauma response.
        J Emerg Med. 2015; 49: 878-885
        • Littlejohn L.
        • Bennett B.
        • Drew B.
        Application of current hemorrhage control techniques for backcountry care: part two, hemostatic dressings and other adjuncts.
        Wilderness Environ Med. 2015; 26: 246-254
        • Drew B.
        • Bennett B.
        • Littlejohn L.
        Application of current hemorrhage control techniques for backcountry care: part one, tourniquets and hemorrhage control adjuncts.
        Wilderness Environ Med. 2015; 26: 236-245