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April 16, 2015
When to use hemostatic agents in EMS
Hemorrhage is responsible for about 40 percent of the deaths following traumatic injury, with 33 to 56 percent of those deaths occurring during the prehospital period (Kauvar, Lefering, & Wade, 2006). Early trauma care stresses the importance of minimizing blood loss in the prehospital environment. There is no debate about the importance of hemorrhage control as a first step in reducing death following traumatic injury.
Hemostatic agents and EMS
To date, no topical hemostatic agent meets all these criteria. However, there are a number of agents available on the market. Physicians categorize these agents into one of three groups based on the mechanism of action: mucoadhesive agents, factor concentrators, or procoagulant supplements (Granville-Chapman, Jacobs, & Midwinter, 2011).
Mucoadhesive agents: Using salt to promote clotting
Researchers found HemCon® to be clinically superior to standard gauze in a low-pressure, high-flow model of venous bleeding (Pusateri et al., 2003), although this type of injury might not represent the injury patterns encountered in the prehospital environment (Lawton, Granville-Chapman, & Parker, 2009). In a high-pressure model of uncontrolled arterial hemorrhage, HemCon® was initially effective at controlling but could not sustain hemostasis (Kheirabadi, Acheson, Sondeen, Ryan, & Holcomb, 2004).
Despite this failure, a retrospective review of 34 cases of hemorrhage treated with HemCon® by Portland, Ore. firefighters revealed bleeding control in 79 percent of the cases (Brown, Daya, & Worley, 2009). On the other hand, in a side by side comparison of commonly used topical hemostatic agents in a swine model of uncontrolled hemorrhage, Celox™ was the only agent that improved short term survival (Kozen, Kircher, Henao, Godinez, & Johnson, 2008).
Factor concentrators: Super dehydrator
In addition to its water absorbing properties, an in vitro examination revealed zeolite also rapidly increases calcium ion concentration of blood, which promotes rapid clot formation (Li et al., 2013). In the first generation of QuikClot®, healthcare providers poured the zeolite granules directly into the wound. However, physicians soon found the exothermic reaction was significant enough to cause burns and tissue necrosis (McManus, Hurtado, Pusateri, & Knoop, 2007; Rhee, et al., 2008; Wright et al., 2004). As a result, the granular form of QuikClot® is no longer available.
The second generation of QuikClot® replaced the granules with larger zeolite beads and packed them into a small mesh bag (QuikClot® ACS+™) that was inserted into the bleeding wound. The bag facilitates removal of the product during surgery. Changes in the second generation of the product reduced the temperatures created by the reaction and produced a safer topical agent (Ahuja et al., 2006).
One factor concentrator that does not produce an exothermic reaction is WoundStat™, which is a biodegradable powder composed of smectite clay mineral and a cross-linked poly-acrylic acid (Lawton, Granville-Chapman, & Parker, 2009). Smectite particles have a negative charge which activates coagulation pathways and promotes clotting (Kheirabadi et al., 2010).
Although early animal studies demonstrated the effectiveness of WoundStat™ in controlling hemorrhage and improving survival (Clay, Grayson, & Zierold, 2010; Kheirabadi et al., 2009; Ward et al., 2007), a subsequent study demonstrated the active particles in WoundStat™ damaged blood vessel linings, caused occlusive thrombus in injured vessels and migrated to the pulmonary vasculature (Kheirabadi et al., 2010). As a result, this product was removed from the market (Kerby & Cusick, 2012).
Other factor concentrators, such as TraumaDex™, use microporous polysaccharide hemospheres derived from potato starch. When compared to QuikClot® in a swine groin wound model, this product proved less effective and in fact, was no better than standard gauze dressings (Alam et al., 2003).
Procoagulant supplements: Faster clotting
The only procoagulant supplement approved by the Food and Drug Administration is Combat Gauze™ (Littlejohn, Bennett, & Drew, 2015). This product is actually the third generation of QuikClot® products in which the manufacturer replaced the zeolite with kaolin, a clay containing the active ingredient aluminum silicate. Combat Gauze™ uses gauze dressings impregnated with kaolin. An animal model determined Combat Gauze™ to be as effective as the second generation QuikClot® at controlling hemorrhage without producing excessive heat (Baker, Sawvel, Zheng, & Stucky, 2007).
Researchers conducting an evidence-based review in an attempt to determine if Combat Gauze™ was safe for controlling hemorrhage in the prehospital setting determined that although not conclusive, the results in support of the product were promising (Gegel, Austin, & Johnson, 2013).
A side-by side comparison of four hemostatic dressings in an animal model of arterial hemorrhage demonstrated survival superiority associated with the use of Combat Gauze™ (Kheirabadi, Scherer, Estep, Dubick, & Holcomb, 2009). In this study, researchers planned to test each of the products in 10 animals. However, two of the chitosan-based products (HemCon® and Celox™-D) failed to achieve hemostasis in the first six tests and all of the animals died. As a result, the researchers did not test those products in the final four animals.
In a similar study, researchers found rebleeding after initial hemostasis in 33% of the animals treated with Celox™ gauze compared to no rebleeding seen in animals treated with Combat Gauze™(Rall et al., 2012).
In an animal model of uncontrolled hemorrhage, researchers tested whether Combat Gauze™ produced a more stable clot compared to standard wound packing practices (Gegel et al., 2012). After achieving hemostasis, the researchers moved the animals affected leg to simulate movement that might occur during evacuation and transportation to more definitive care. The number of movements required to produce rebleeding after using Combat Gauze™ was significantly higher compared to standard wound packing therapy.
Clinicians have even reported success in using Combat Gauze™ to control bleeding related to percutaneous catheter insertion sites for patients undergoing extracorporeal membrane oxygenation (ECMO) support (Lamb, Pitcher, Cavarocchi, & Hirose, 2012). Use of safe and effective hemostatic dressings for patients undergoing ECMO has the potential to reduce the need for blood transfusions, surgical exploration, overall healthcare costs, and promote faster patient recovery.
Tactical Combat Casualty Care guidelines developed by the United States Special Operations Command recommend Combat Gauze™ as the hemostatic dressing of choice (Bennett et al., 2014). However, the guidelines allow for alternative use of Celox™ gauze and ChitoGauze® in the event Combat Gauze™ is not available.
Hemostatic agents: Current recommendation
Ahuja, N., Ostomel, T. A., Rhee, P., Stucky, G. D., Conran, R., Chen, Z., Al-Mubarak, G. A., Velmahos, G., Demoya, M., & Alam, H. B. (2006). Testing of Modified zeolite hemostatic dressing in a large animal model of lethal groin injury. Journal of Trauma-Injury Infection & Critical Care, 57(2), 61(6), 1312–1320. doi:10.1097/01.ta.0000240597.42420.8f
Alam, H. B., Uy, G. B., Miller, D., Koustova, E. Hancock, T., Inocencio, R., Anderson, D., Llorente, O., & Rhee, P. (2003). Comparative analysis of hemostatic agents in a swine model of lethal groin injury. Journal of Trauma-Injury Infection & Critical Care, 54(6), 1077-1082. doi:10.1097/01.TA.0000068258.99048.70
Baker, S. E., Sawvel, A. M., Zheng, N., & Stucky, G. D. (2007). Controlling bioprocesses with inorganic surface: Layered clay hemostatic agents. Chemistry of Materials, 19(18), 4390-4392. doi:10.1021/cm071457b
Bennett, B. L., Littlejohn, L. F., Kheirabadi, B. S., Butler, F. K., Kotwal, R. S., Dubick, M. A., & Bailey, J. A. (2014). Management of external hemorrhage in tactical combat casualty care: Chitosan-based hemostatic gauze dressings - TCCC Guidelines-Change 13-05. Journal of Special Operations Medicine, 14(3), 40-57.
Brown, M. A., Daya, M. R., & Worley, J. A. (2009). Experience with chitosan dressings in a civilian EMS system. Journal of Emergency Medicine, 37(1), 1-7. doi:10.1016/j.jemermed.2007.05.043
Bulger, E. M., Snyder, D., Schoelles, K., Gotschall, C., Dawson, D., Lang, E., Sanddal, N. D., Butler, F. K., Fallat, M., Taillac, P., White, L., Salomone, J. P., Seifarth, W., Betzner, M. J., Johannigman, J., & McSwain, N. Jr. (2014). An evidence-based prehospital guideline for external hemorrhage control: American College of Surgeons Committee on Trauma. Prehospital Emergency Care, 18(2), 163-173. doi:10.3109/10903127.2014.896962
Burkatovskaya, M., Tegos, G. P., Swietlik, E., Demidova, T. N., P Castano, A., & Hamblin, M. R. (2006). Use of chitosan bandage to prevent fatal infections developing from highly contaminated wounds in mice. Biomaterials, 27(22), 4157–4164. doi:10.1016/j.biomaterials.2006.03.028
Clay, J. G., Grayson, J. K., & Zierold, D. (2010). Comparative testing of new hemostatic agents in a swine model of extremity arterial and venous hemorrhage. Military Medicine, 175(4), 280–284.
Gegel, B. T., Austin, P. N., & Johnson, A. D. (2013). An evidence-based review of the use of a combat gauze (QuikClot) for hemorrhage control. AANA Journal, 81(6), 453-458.
Gegel, B., Burgert, J., Gasko, J., Campbell, C., Martens, M., Keck, J., Reynolds, H., Loughren, M., & Johnson, D. (2012). The effects of QuikClot Combat Gauze and movement on hemorrhage control in a porcine model. Military Medicine, 177(12), 1543-1547.
Granville-Chapman, J., Jacobs, N., & Midwinter, M. J. (2011). Pre-hospital haemostatic dressings: A systematic review. Injury, 42(5), 447–459. doi:10.1016/j.injury.2010.09.037
Kerby, J. D., & Cusick, M. V. (2012). Prehospital emergency trauma care and management. Surgical Clinics of North America, 92(4), 823–841 doi:10.1016/j.suc.2012.04.009
Kheirabadi, B. S., Acheson, E. M., Sondeen, J. L., Ryan, K. L., & Holcomb, J. B. (2004). Hemostatic effect of two advanced dressings in an aortic hemorrhage model in swine [abstract]. Journal of Trauma-Injury Infection & Critical Care, 57(2), 439.
Kheirabadi, B. S., Scherer, M. R., Estep, J. S., Dubick, M. A, & Holcomb, J. B. (2009). Determination of efficacy of new hemostatic dressings in a model of extremity arterial hemorrhage in swine. Journal of Trauma-Injury Infection & Critical Care, 67(3), 450-459. doi:10.1097/TA.0b013e3181ac0c99
Kheirabadi, B. S., Edens, J. W., Terrazas, I. B., Estep, J. S., Klemcke, H. G., Dubick, M. A., & Holcomb, J. B. (2009). Comparison of new hemostatic granules/powders with currently deployed hemostatic products in a lethal model of extremity arterial hemorrhage in swine. Journal of Trauma-Injury Infection & Critical Care, 66(2), 316-328. doi:10.1097/TA.0b013e31819634a1
Kheirabadi, B. S., Mace, J. E., Terrazas, I. B., Fedyk, C. G., Estep, J. S., Dubick, M. A., & Blackbourne, L. H. (2010). Safety evaluation of new hemostatic agents, smectite granules, and kaolin-coated gauze in a vascular injury wound model in swine. Journal of Trauma-Injury Infection & Critical Care, 68(2), 269–278. doi:10.1097/TA.0b013e3181c97ef1
Kozen, B. G., Kircher, S. J., Henao, J., Godinez, F. S., & Johnson, A. S. (2008). An alternative hemostatic dressing: Comparison of CELOX, HemCon, and QuikClot. Academic Emergency Medicine, 15(1), 74-81. doi:10.1111/j.1553-2712.2007.00009.x
Kauvar, D. S., Lefering, R., & Wade, C. E. (2006). Impact of hemorrhage on trauma outcome: An overview of epidemiology, clinical presentations, and therapeutic considerations. Journal of Trauma-Injury Infection and Critical Care, 60(6 Suppl), S3-S11. doi:10.1097/01.ta.0000199961.02677.19
Lamb, K. M., Pitcher, H. T., Cavarocchi, N. C., & Hirose, H. (2012). Vascular site hemostasis in percutaneous extracorporeal membrane oxygenation therapy. The Open Cardiovascular and Thoracic Surgery Journal, 5, 8-10. doi:10.2174/1876533501205010008
Lawton, G., Granville-Chapman, J., & Parker, P. (2009). Novel haemostatic dressings. Journal of the Royal Army Medical Corps, 155(4), 309-314 doi:10.1136/jramc-155-04-13
Li, J., Cao, W., Lv, X. X., Jiang, L., Li, Y. J., Li, W. Z., Chen, S. Z., & Li, X. Y. (2013). Zeolite-based hemostat QuikClot releases calcium into blood and promotes blood coagulation in vitro. Acta Pharmacologica Sinica, 34(3), 367-372. doi:10.1038/aps.2012.159
Littlejohn, L., Bennett, B. L., & Drew, B. (2015). Application of current hemorrhage control techniques for backcountry care: Part two, hemostatic dressings and other adjuncts [Article in Press]. Wilderness and Environmental Medicine. doi:10.1016/j.wem.2014.08.018
McManus, J., Hurtado, T., Pusateri, A., & Knoop, K. J. (2007). A case series describing thermal injury resulting from zeolite use for hemorrhage control in combat operations. Prehospital Emergency Care, 11(1), 67–71. doi:10.1080/10903120601021176
Pusateri, A. E., McCarthy, S. J., Gregory, K. W., Harris, R. A., Cardenas, L., McManus, A. T., & Goodwin, C. W. Jr. (2003). Effect of a Chitosan-based hemostatic dressing on blood loss and survival in a model of severe venous hemorrhage and hepatic injury in swine. Journal of Trauma, 54(1), 177-182.
Rall, J. M., Cox, J. M., Songer, A. G., Comeaux, J. A., Estep, S., Cestero, R. F., & Ross, J. D. (2012). Comparison of novel hemostatic gauzes to Quickclot Combat Gauze in a standardized swine model of uncontrolled hemorrhage (Technical Report No. TR-2012-22). San Antonio, TX: Naval Medical Research Unit
Rhee, P., Brown, C., Martin, M., Salim, A., Plurad, D., Green, D., Chambers, L., Demetriades, D., Velmahos, G., & Alam, H. (2008). QuikClot use in trauma for hemorrhage control: Case series of 103 documented uses. Journal of Trauma-Injury Infection and Critical Care, 64(4), 1093–1099. doi:10.1097/TA.0b013e31812f6dbc
Ward, K. R., Tiba, H., Holbert, W. H., Blocher, C. R., Draucker, G. T., Proffitt, E. K., Bowlin, G. L., Ivatury, R. R., & Diegelmann, R. F. (2007). Comparison of a new hemostatic agent to current combat hemostatic agents in a swine model of lethal extremity arterial hemorrhage. Journal of Trauma-Injury Infection & Critical Care, 2007; 63(2), 276-284. doi:10.1097/TA.0b013e3180eea8a5
Wright, J. K., Kalns, J., Wolf, E. A., Traweek, F., Schwarz, S., Loeffler, C. K., Snyder, W., Yantis, L. D. Jr., & Eggers, J. (2004). Thermal injury resulting from application of a granular mineral hemostatic agent. Journal of Trauma-Injury Infection and Critical Care, 57(2), 224–230. doi:10.1097/01.TA.0000105916.30158.06