CONTINUING EDUCATION Hemostatic Agents: A Guide to Safe Practice for Perioperative Nurses 3.0 MARGARET A. CAMP, MSN, BSN, RN www.aorn.org/CE Continuing Education Contact Hours Approvals indicates that continuing education (CE) contact hours are available for this activity. Earn the CE contact hours by reading this article, reviewing the purpose/goal and objectives, and completing the online Examination and Learner Evaluation at http://www.aorn.org/CE. A score of 70% correct on the examination is required for credit. Participants receive feedback on incorrect answers. Each applicant who successfully completes this program can immediately print a certificate of completion. This program meets criteria for CNOR and CRNFA recertification, as well as other CE requirements. AORN is provider-approved by the California Board of Registered Nursing, Provider Number CEP 13019. Check with your state board of nursing for acceptance of this activity for relicensure. Event: #14527 Session: #0001 Fee: Members $24, Nonmembers $48 The CE contact hours for this article expire August 31, 2017. Pricing is subject to change. Purpose/Goal To provide the learner with knowledge specific to the effective management of bleeding during operative and other invasive procedures and the use of hemostatic agents to augment the patient’s natural clotting abilities. Objectives 1. Discuss why hemostasis is needed during operative and other invasive procedures. 2. Describe the basic mechanisms that naturally occur to promote hemostasis. 3. Discuss the clinical indications for the use of hemostatic agents. Conflict of Interest Disclosures Having received money for the development of education programs and for travel, accommodations, and meeting expenses from Ethicon, Margaret A. Camp, MSN, BSN, RN, has declared an affiliation that could be perceived as posing a potential conflict of interest in the publication of this article. The behavioral objectives for this program were created by Rebecca Holm, MSN, RN, CNOR, and Helen Starbuck Pashley, MA, BSN, CNOR, clinical editors, with consultation from Susan Bakewell, MS, RN-BC, director, Perioperative Education. Ms Holm, Ms Starbuck Pashley, and Ms Bakewell have no declared affiliations that could be perceived as posing potential conflicts of interest in the publication of this article. Sponsorship or Commercial Support No sponsorship or commercial support was received for this article. Disclaimer Accreditation AORN is accredited as a provider of continuing nursing education by the American Nurses Credentialing Center’s Commission on Accreditation. AORN recognizes these activities as CE for RNs. This recognition does not imply that AORN or the American Nurses Credentialing Center approves or endorses products mentioned in the activity. http://dx.doi.org/10.1016/j.aorn.2014.01.024 Ó AORN, Inc, 2014 August 2014 Vol 100 No 2 AORN Journal j 131 Hemostatic Agents: A Guide to Safe Practice for Perioperative Nurses 3.0 MARGARET A. CAMP, MSN, BSN, RN www.aorn.org/CE ABSTRACT Perioperative hemostasis, the effective management of bleeding during operative and other invasive procedures, can involve the use of blood, blood products, and hemostatic agents to augment the patient’s natural clotting abilities. Currently, more than 50 hemostatic products are available in the marketplace and dozens more are in development. It is important for perioperative nurses to understand each of the hemostatic agent categories and their actions, properties, applications, and limitations. This article provides an overview of the normal coagulation process (ie, clotting cascade) that is activated by the body when there is a bleeding episode; the management of blood products and the rationale for reducing their use; the financial implications of hemostatic agent use; and how these agents are used, their clinical indications, and potential complications from their use. AORN J 100 (August 2014) 132-144. Ó AORN, Inc, 2014. http://dx.doi.org/10.1016/j.aorn.2014.01.024 Key words: clotting cascade, bleeding, hemostasis, hemostatic agents. S ince ancient times, people have searched for ways to effectively control bleeding, especially when the body’s normal clotting responses are insufficient to accomplish satisfactory hemostasis (ie, the reduction or stoppage of blood flow). In early times, bandaging, pressure, or crude forms of cautery applied to a wound had to suffice until the idea of using thread to suture wounds became common; eventually, barbers and boxers discovered that thrombin could be used to stop bleeding.1 As early as the 1940s, surgeons were using thrombin in surgery to stop bleeding.1 The use of thrombin in surgery for hemostasis has increased exponentially since then. In the past decade, the emergence of commercially prepared hemostatic agents has been unsurpassed. In today’s OR, surgeons have a broad range of products to help control bleeding. Selecting the right product for the right procedure and using it correctly has increasingly become a challenge given the current depth and breadth of products currently available in the marketplace. Effective management of bleeding during operative and other invasive procedures is a critical factor in achieving optimal patient outcomes. It is important for the perioperative nurse to understand the clotting cascade, clinical indications for using hemostatic agents, the types of hemostatic agents http://dx.doi.org/10.1016/j.aorn.2014.01.024 132 j AORN Journal August 2014 Vol 100 No 2 Ó AORN, Inc, 2014 HEMOSTATIC AGENTS: A GUIDE TO SAFE PRACTICE available and their actions, and the potential limitations or complications of these products. In addition, understanding the importance of blood and blood product management is imperative. Today, there is increased focus on cost containment because of changes in reimbursement to health care providers as well as a growing elderly population in the United States with higher acuity levels and greater use of medical and surgical services.2 These factors are some of the primary drivers that push providers to look for more efficient and effective ways to provide surgical care, less costly alternatives to the traditional surgical procedures, and ways to use products and supplies more effectively, including blood, blood products, and other hemostatic agents. In the United States, operative and other invasive procedures account for the transfusion of more than 15 million units of packed red blood cells per year.3 In addition to the knowledgeable use of hemostatic agents, health care providers are encouraged to reduce the use of blood and blood products because of the evidence that limiting their use improves patient outcomes and reduces the incidence of surgical site infections, costs, and a patient’s risk of complications.4 In addition to these concerns and reasons for reducing blood product usage, there are also concerns that the supply of blood donors is declining and the blood supply itself is diminishing despite a heavy emphasis on blood conservation measures.3 HEMOSTASIS During any operative or invasive procedure, surgeons frequently need to achieve some level of hemostasis. Although the need to control brisk arterial bleeding is obvious, surgeons also need to control oozing from small vessels. For example, Spahn et al5 reported that 50% of trauma-related deaths are the result of uncontrolled bleeding. Generally, bleeding from an arterial source can be controlled by mechanical means, such as direct pressure with sponges or gauze or the application of sutures, staples, or clips. Bleeding that is more www.aornjournal.org difficult to control occurs when the patient experiences diffuse venous bleeding. This can result in coagulopathy, which develops because the body is unable to compensate for the rapid consumption and dilution of platelets and coagulation factors during an emergent bleeding episode.6 Therefore, it is imperative to control bleeding and achieve hemostasis as quickly as possible to avoid the complications of coagulopathy. When a vessel is damaged either by accident (eg, trauma) or by intention (eg, surgical incision), basic mechanisms occur naturally to promote hemostasis: vasoconstriction, the formation of a platelet plug, and coagulation.7 Vasoconstriction After vessel injury occurs, vasoconstriction is the body’s first response to mechanically slow bleeding. In the vasoconstriction phase, the body attempts to slow the flow of blood by both local and systemic mediators. At the local level, thromboxane is released to aid in vessel constriction. The adrenal glands also release epinephrine, which acts systemically to increase vasoconstriction and slow bleeding.8 After vessel constriction, the body responds to quickly form a platelet plug. 7 This platelet plug is temporary and unstable, and a fibrin clot needs to form to provide lasting hemostasis. Platelet Plug Formation In this phase of hemostasis, circulating thrombin causes the release of additional platelets that initiate the formation of a loose platelet plug. Fibrinogen, a component of the clotting mechanism or cascade, is responsible for the clumping of platelets, which adhere to collagen fibers and release chemicals such as adenosine diphosphate. The platelets also release other mediators (eg, serotonin, phospholipids, lipoproteins, other proteins) that are important in the clotting cascade. The platelet plug acts as a temporary measure to stem the flow of blood in the injured vessel. Although the platelet plug is important, its action is to seal the tear rather than occlude the vessel lumen.3 AORN Journal j 133 CAMP August 2014 Vol 100 No 2 Unfortunately, platelet plugs are not effective in controlling hemorrhage from large vessels, and it is then that the body’s coagulation mechanisms must be activated to form a permanent fibrin clot.3 Coagulation The third phase, coagulation, is a complex bodily response that involves multiple factors and processes. Coagulation is the transformation of liquid blood into a gelatin-like substance (ie, a clot). Approximately a dozen clotting factors normally exist as inactive proteins in the circulating blood. An injury to a vessel causes these circulating proteins to be activated. The activation of these clotting factors is sequential in nature; when the first factor is activated, it automatically causes subsequent factors to be activated in a very specific order.9 This process is known as the clotting cascade and eventually a clot is formed, which seals the injured vessel. CLOTTING CASCADE The clotting cascade is composed of intrinsic and extrinsic pathways, and the key mediator of both pathways is thrombin. Thrombin is derived from an inactive substance called prothrombin. The clotting cascade pathways, while triggered by two different mechanisms, act synchronously. Both of these pathways are complex and merge to create what is known as the common pathway of hemostasis, the end product of which is the formation of a fibrin clot.4 An illustration of the clotting cascade is available in the article by Overbey et al10 that appears in this issue of AORN Journal. Intrinsic Pathway During normal blood flow, inactivated coagulation proteins circulate in the blood. Under normal circumstances, blood flows briskly and moves these proteins through the vessels. The lining of the blood vessels (ie, the endothelium) does not contain thrombogenic tissue factor or collagen, and it promotes blood flow rather than coagulation.4 The intrinsic pathway to activate the clotting factors in 134 j AORN Journal the blood is not initiated from a vessel injury and can be triggered by blood stasis (eg, deep vein thrombosis, thromboembolism). When the intrinsic pathway is activated, it triggers activation of factors XIIa, XIa, IXa, and Xa in combination with calcium in the blood to initiate coagulation. Extrinsic Pathway Damage outside a vessel wall also can activate a cascade of clotting factors. When the vessel’s subendothelial connective tissues are exposed to the escaping blood, they stimulate the activation of tissue thromboplastin, which causes factor X to be activated. It is at this point that both the intrinsic and extrinsic factors converge into the common pathway. Whenever either pathway is initiated, the basic response is the exposure of platelets to collagen, which causes an initial clot to form. It is important to note that the clotting cascade begins sooner when the extrinsic pathway is initiated because it bypasses some of the steps required for the intrinsic pathway process to occur.4 Common Pathway The common pathway of the coagulation cascade occurs when the intrinsic and extrinsic pathways of coagulation meet through activation of factor X. Activated factor X in combination with platelets, factor V, and calcium convert prothrombin to thrombin. The role of thrombin in the coagulation cascade includes the activation of n fibrinogen to form a fibrin clot; n factor XIII to stabilize the clot; n platelets to assist in sealing the clot; and n factors V, VII, and XI, which are needed to stimulate the production of more thrombin molecules. This is essential for fibrin strands to form a mesh and subsequently form a hemostatic plug.4 There are many factors involved in the clotting cascade (Table 1). Of these elements, one of the key factors in achieving hemostasis through both normal body responses and surgical intervention HEMOSTATIC AGENTS: A GUIDE TO SAFE PRACTICE www.aornjournal.org TABLE 1. Factors Involved in the Clotting Cascade Fibrinogen n n Prothrombin n n Vitamin K Calcium Factor X Factors XI, XII, XIII Factor V Thrombin Fibrin Platelets n n n n n n n n n Intrinsic factors Extrinsic factors n Common factors n n n Converted to fibrin by fibrinogen Forms the clot Converted to thrombin by factor X Once activated, converts fibrinogen to fibrin Required to synthesize fibrinogen to fibrin Promotes platelet aggregation in combination with factors VII, X, XII, and XIII Combined with other clotting factors converts prothrombin to thrombin Acts to catalyze other factors in the coagulation process Another element needed to convert prothrombin to thrombin Converts fibrinogen to fibrin Initially forms a loose mesh; in combination with factor XIII facilitates formation of dense fiber mesh Initially stick to vessel collagen to form a loose plug Part of the foundation of the fibrin clot along with red blood cells When an internal vessel injury occurs, factors XIIa, IXa, VIIa, and Xa are activated When an external vessel injury occurs and the endothelium is disrupted, factors VIIa and X are activated in combination with calcium and membrane phospholipids The point where the intrinsic and extrinsic pathways merge or converge through activation of factor X Subsequently, other elementsdincluding factor V and calcium in combination with plateletsdconvert prothrombin to thrombin, which causes fibrinogen to form the fibrin clot (ie, use of commercially prepared hemostatic agents) is thrombin. Thrombin is the key enzyme in blood coagulation. It is a sodium-activated protease and is one of the body’s inherent defense mechanisms. Thrombin was one of the earliest enzymes identified as a hemostatic agent and was a precursor to many other vitamin K proteases, such as factors VIIa, IXa, and Xa, which are critical for the convergence of the intrinsic and extrinsic pathways in the coagulation cascade.11 Thrombin, whether in its natural form in the body or as part of a commercially prepared product, has two distinct but opposing functions. It acts to support coagulation when it converts fibrinogen to a fibrin clot that holds the platelets in place at the bleed site and starts the healing process. Conversely, thrombin acts as an anticoagulant when it activates protein C.9 For example, when there is no vascular disruption, thrombin improves circulation through its anticoagulant action.1 TRADITIONAL HEMOSTATIC METHODS There are three traditional hemostatic methods. These include mechanical hemostasis via direct pressure (eg, manual pressure, pressure dressings) or mechanical products (eg, ligatures [ie, sutures], staples, clips, clamps), thermal-based energy (eg, monopolar, bipolar, ultrasonic, laser, argon vessel sealing), and chemical agents (eg, epinephrine, vitamin K, protamine, vasopressors). Mechanical Hemostasis The most common mechanical approach to control bleeding is the application of direct pressure to the bleeding site. Direct pressure is always the first choice when there is a need to control bleeding; it is the easiest, simplest, and most cost-effective method of hemostasis. Direct pressure can be applied manually or with pressure dressings. Other mechanical hemostasis methods, such as sutures, staples, and vascular clips or clamps, also can be used. Sutures, clips, or ligatures offer a reasonably easy and cost-effective method to control bleeding; however, the practitioner needs to understand that the physical configuration of the product being used may have different reactions in the patient’s body. Some other considerations when choosing a product are ease of use (ie, how easy the AORN Journal j 135 CAMP August 2014 Vol 100 No 2 item is to handle) and whether the product will achieve the desired hemostasis over time. Staples and clips, which are foreign bodies, increase the possibility of a foreign body reaction or improper placement. Another factor to consider is the site of the bleeding. Although arterial bleeding is more challenging to control given the volume of blood involved, arteries are generally easier to control than diffuse capillary bleeding because of their size and accessibility. Diffuse capillary bleeding often involves large, hard-to-reach areas, especially in minimally invasive procedures. Unfortunately, mechanical methods are not always practical or effective, depending on the severity and location of the bleeding; in addition, although effective for most bleeding, none of the mechanical methods may be effective if the patient has a coagulopathy or has been on anticoagulant medication.12 Thermal-Based Energy In addition to pressure or other mechanical methods of hemostasis, surgeons often use thermal energy to achieve hemostasis. Although the most common thermal energy application is monopolar electrosurgery, other thermal adjuncts include bipolar cautery, lasers, vessel sealing devices, ultrasonic waves, and argon-enhanced coagulation. Generally, these methods are cost-effective; however, these approaches may be ineffective on specific bleeding sites, such as bone, friable tissue, or areas with diffuse capillary bleeding.3,4 Energy-based hemostasis also carries the potential risk of destroying healthy tissue and causing burns to adjacent tissue because of stray currents.3 normal body coagulation mechanisms if they are not administered correctly.4 TOPICAL HEMOSTATIC AGENTS When traditional hemostatic methods (eg, mechanical, thermal, chemical) fail to achieve hemostasis, a wide variety of topical hemostatic agents are available for use. The ideal hemostatic agent requires ease of use, but it also must be safe, effective, and cost-effective and have US Food and Drug Administration (FDA) approval. From a safety perspective, the products need to be free of infectious diseases and carcinogens, and they should not have the potential to create immune reactions in the patient.2 The products must work for the clinical indication for which they are approved, and the surgeon must use the products according to the clinical needs of the patient. For instance, using a hemostatic agent as a first response to a bleeding situation may not be ideal if other commonly used measures (eg, pressure, sutures, thermal energy) have not been tried. The products must also be easy to access, prepare, and use. When there is significant bleeding, it is important that the RN circulator can deliver the sterile product to the field efficiently. For a product to be cost-effective involves both its acquisition cost and the amount of product needed to achieve hemostasis. The RN circulator can help by selecting the correct size of the product needed. Generally, topical hemostatic agents are assigned to one of five major groups: n Chemical Agents The use of chemical agents is a third method that surgeons often use for achieving hemostasis. These agents include epinephrine, vitamin K, protamine, and vasopressors. Although they are sometimes effective, the disadvantages of using these products are their potential effects on the natural clotting cascade. Although the role of chemical agents is to enhance hemostasis, they can negatively affect the 136 j AORN Journal passive (ie, mechanical) agents (eg, oxidized regenerated cellulose, beeswax), n active agents (eg, bovine thrombin, pooled human thrombin, recombinant thrombin), n flowables (eg, bovine gelatin particles, human thrombin, porcine gelatin particles with or without pooled human or recombinant thrombin), n fibrin sealants (eg, human plasma-derived fibrin sealants, the patient’s own plasma combined with bovine collagen and thrombin, the patient’s HEMOSTATIC AGENTS: A GUIDE TO SAFE PRACTICE own plasma used to create fibrinogen and thrombin), and n adhesives (eg, skin sealants, synthetic tissue sealants, glutaraldehydes, polyethylene glycol polymers). All of the products have unique properties, applications, and safety considerations. For example, fibrin sealants require the presences of fibrin to be www.aornjournal.org effective. Adhesives also provide hemostasis but have different properties and applications than other hemostatic agents and do not require a blood component to be present for activation.3,13 Because hemostatic agents act in different phases of the coagulation cascade, it is important for the perioperative nurse, as the patient’s advocate, to be knowledgeable about the products he or she is delivering to the surgeon. Table 2 provides a broad TABLE 2. Commercially Prepared Hemostatic Agents Category Passive (ie, mechanical) Type Porcine gelatin Commercial name n n Bovine collagen n n n n Oxidized regenerated cellulose n n n Polysaccharide spheres Beeswax, paraffin, isopropyl palmate n n n n Active Flowable Fibrin sealant Bovine thrombin Pooled human thrombin Recombinant thrombin Bovine gelatin and pooled human thrombin Bovine gelatin (and/or thrombin) Pooled human plasma n n n n n n n Adhesives Patient’s own plasma and bovine thrombin Patient’s own plasma Polyethylene glycol hydrogels (PEG) PEG þ trilysine amine PEG þ human serum albumin Liquid monomers n n n n n n n n Synthetic tissue sealants Glutaraldehyde cross-linked with bovine albumin n n GELFOAMÒ SURGIFOAMÒ powder and sponge AviteneTM HelistatÒ INSTATÒ UltrafoamTM SURGICELÒ SURGICEL FIBRILLARTM SURGICEL NU-KNITÒ SURGICEL SNoWTM AristaTM VitasureÒ Bone wax Thrombin-JMIÒ EVITHROMÒ RecothromÒ FLOSEALÒ SURGIFLOÒ EVICELÒ TISSEELTM VitagelTM CryoSealÒ CoSealTM DuraSealTM ProgelÒ DERMABONDÒ LiquiBandÒ SurgiSealÒ OMNEXTM BioGlueÒ GELFOAM and FLOSEAL are registered trademarks and TISSEEL and CoSeal are trademarks of Baxter Corporation, Deerfield, IL. SURGIFOAM, INSTAT, SURGICEL, SURGICEL NU-KNIT, EVITHROM, SURGIFLO, EVICEL, and DERMABOND are registered trademarks and SURGICEL FIBRILLAR, SURGICEL SNoW, and OMNEX are trademarks of Ethicon, Johnson & Johnson, Inc, Somerville, NJ. Avitene and Ultrafoam are trademarks of Davol/Bard Company, Warwick, RI. Helistat is a registered trademark of Integra Life Sciences Corporation, Plainsboro, NJ. Arista is a trademark of Medafor, Minneapolis, MN. Vitasure is a registered trademark of Orthovita, Malvern, PA. Thrombin-JMI is a registered trademark of Pfizer, New York, NY. Recothrom is a registered trademark of The Medicines Company, Parsippany, NJ. Vitagel is a trademark of Stryker, Malvern, PA. CryoSeal is a registered trademark of ThermoGenesis Corporation, Rancho Cordova, CA. DuraSeal is a trademark of Covidien, Boulder, CO. Progel is a registered trademark of NeoMend, Irvine, CA. LiquiBand is a registered trademark of Cardinal Health, Dublin, OH. SurgiSeal is a registered trademark of Adhezion Biomedical, Wyomissing, PA. BioGlue is a registered trademark of CryoLife, Kennesaw, GA. AORN Journal j 137 CAMP August 2014 Vol 100 No 2 overview (but is not an all-inclusive list) of many of the products in these groups. The important information for the perioperative nurse is which products fall into which category. Passive Hemostatic Agents Passive hemostatic agents also are referred to as mechanical agents (Table 3). Although they are relatively inexpensive, easy to prepare, and have no special storage requirements, most of these products should not be used in confined areas of the body where swelling would cause problems. They are effective for areas of minimal bleeding, so they generally are not effective for diffuse capillary or brisk arterial bleeding. They require the presence of blood for activation and do not affect or interrupt the clotting cascade. Passive hemostatic agents have been used since the 1940s and were the first generation of commercially prepared hemostatic agents.14 Active Hemostatic Agents Active hemostatic agents (Table 4) provide hemostasis within 10 minutes and control bleeding better than passive agents alone.4 Currently, there are three available active agents that are based on thrombin (ie, pooled human thrombin, bovine thrombin, recombinant thrombin). Their function is to provide a concentrated thrombin that is capable of converting fibrinogen to a fibrin clot, which provides a framework for platelet aggregation and thrombus formation at the site of the injury.9 The rate of clot formation is directly proportional to the concentration of thrombin. Although there are products with TABLE 3. Passive (ie, Mechanical) Hemostatic Agents Indication Composition/origin Minimal bleeding Porcine gelatin Clinical considerations n n n n Minimal bleeding Bovine collagen n n n n n n Minimal bleeding Oxidized regenerated cellulose n n n n n n Minimal bleeding Polysaccharide spheres Minimal bleeding Beeswax, paraffin, isopropyl palmate n n n n n n n Do not inject Do not use in the presence of infection Risk of swelling Risk of granuloma/abscess formation Do not inject Do not use in the presence of infection Risk of swelling Risk of granuloma/abscess formation May contribute to adhesion formation Sticks to the surgeon’s gloves and instruments Do not inject Broad indications for use Bactericidal Nonhuman/animal source No preparation needed Multiple thicknesses Do not inject Nonhuman/animal source No preparation needed Do not inject Limited resorption Inhibits bone regeneration Increases infection risk Commercial name n n GELFOAMÒ SURGIFOAMÒ powders and sponges n AviteneTM sponge and powder HelistatÒ HeliteneÒ INSTATÒ UltrafoamTM SURGICELÒ SURGICEL FIBRILLARTM SURGICEL NU-KNITÒ SURGICEL SNoWTM n AristaTM n Bone wax n n n n n n n n GELFOAM is a registered trademark of Baxter Corporation, Deerfield, IL. SURGIFOAM, INSTAT, SURGICEL, and SURGICEL NU-KNIT are registered trademarks and SURGICEL FIBRILLAR and SURGICEL SNoW are trademarks of Ethicon, Johnson & Johnson, Inc, Somerville, NJ. Avitene and Ultrafoam are trademarks of Davol/Bard Company, Warwick, RI. Helistat is a registered trademark of Integra Life Sciences Corporation, Plainsboro, NJ. Helitene is a registered trademark of Colla-Tec, Inc, Plainsboro, NJ. Arista is a trademark of Medafor, Minneapolis, MN. 138 j AORN Journal HEMOSTATIC AGENTS: A GUIDE TO SAFE PRACTICE www.aornjournal.org TABLE 4. Active Hemostatic Agents Indication Composition/origin Localized and Bovine thrombin diffuse bleeding Clinical considerations n n n n n Localized and Pooled human thrombin diffuse bleeding n n n Localized and Recombinant thrombin diffuse bleeding n n Commercial name Broad indications for use Thrombin-JMIÒ Should not be used in patients with bovine allergies Can stimulate antigen formation and interrupt the clotting cascade Has potential for infection transmission Has a “black box” warning Risk of swelling EVITHROMÒ Do not use in patients with allergies to human blood products Unknown potential for infection transmission and interruption of the clotting cascade RecothromÒ Commercially manufactured Clinical studies to date have not demonstrated that this product produces antigens or affects the clotting cascade Thrombin-JMI is a registered trademark of Pfizer, New York, NY. EVITHROM is a registered trademark of Ethicon, Johnson & Johnson, Inc, Somerville, NJ. Recothrom is a registered trademark of The Medicines Company, Parsippany, NJ. lower thrombin concentrations that claim to be as effective as those with higher concentrations (1,000 IU/mL), this should be a consideration in product selection because higher concentrations yield better hemostasis (ie, the speed with which thrombin clots the blood depends on the concentration).3 Safety is a major consideration for thrombin products, because thrombin acts at the end of the clotting cascade and its interaction is negatively affected by coagulopathies, such as clotting factor deficiencies or platelet malfunction. These agents are logical choices for patients receiving antiplatelet or anticoagulant medications. Thrombin also has several other functions within the body. It can cause smooth muscle to constrict, activate platelets, and aggregate platelets at an injury site. It attracts neutrophils and fibroblasts and induces the formation of new cells for tissue and vascular repair and remodeling.1 Bovine and recombinant thrombin products are provided at room temperature but must be reconstituted with saline. Human pooled thrombin comes fully mixed but frozen and requires thawing before use; after thawing, it can be stored in a refrigerator for up to 30 days. The surgeon can apply all of the active hemostatic products directly to bleeding surfaces or by using a spray applicator. These products can be used alone or in combination with an absorbable gelatin sponge or powder. There are commercially manufactured kits that do not require refrigeration and contain a porcine gelatin combined with a lyophilized human pooled thrombin. The cost of these products is intermediate and varies by manufacturer. Perioperative nurses should understand what happens at the vascular interface when thrombin is being used and how this determines the efficacy of the product. The amount of thrombin in the wound can be affected or inhibited by factors such as hemodilution, absorptive sponges, wound irrigation, or continuous wiping or blotting. Inhibitors such as antithrombolytic hormone also can affect the amount of thrombin in the wound by trapping thrombin within the clot as the clot forms. The most effective hemostasis occurs when the thrombin mixes freely with the blood as soon as it reaches the surface of the vessel injury.4 It is also important to understand that all thrombins are not created equal. Perioperative nurses need to understand how the products work and their AORN Journal j 139 August 2014 Vol 100 No 2 reaction in the body both locally and systemically. Because thrombin is a component in several of the other hemostatic agents, this is important for perioperative nurses to understand when providing hemostatic agents during an operative or other invasive procedure. Thrombin is a powerful product that is effective in controlling both arterial and capillary bleeding. It is important to discuss what alternative products might be used that are safer and why. The perioperative nurse must be familiar with the thrombinbased products used, know their origin, and understand the patient implications. The perioperative nurse has a responsibility to help team members determine the appropriate product selection based on the patient’s history. Team members should discuss all pertinent patient information before the procedure. The nurse should know whether the patient n n n n n has a history of allergies or reactions to any hemostatic agents or a history of allergies to bovine or porcine products, has a religious or dietary reason for avoiding hemostatic agents, uses anticoagulant or antiplatelet medications (eg, aspirin, other nonsteroidal antiinflammatory medications) or herbal supplements (eg, vitamin E, bilberry, Ginkgo, garlic, cayenne) that might affect clotting mechanisms, has a family history of bleeding disorders (eg, hemophilia, sickle cell anemia), or is anemic. It is important for the nurse to assess the patient for bleeding gums, easy bruising, excessive superficial bleeds, or severe nosebleeds. The nurse also should know whether the patient has a history of renal or hepatic disease because both the kidneys and liver secrete hormones that affect clotting mechanisms. If these organs are not functioning correctly, this can impede the coagulation process. In addition, the nurse should understand what the proposed procedure is; the patient’s potential for bleeding; and the results of the patient’s coagulation 140 j AORN Journal CAMP profile, blood type, and cross-match. A signed consent for administration of blood or blood products or a signed refusal should be verified and, if appropriate and consent for blood has been given, the nurse should verify that there is autologous blood product available and determine whether the donation has been verified. He or she should ascertain whether there are plans for perioperative blood salvage; if the patient is aware of this; and whether the patient has any cultural, ethnic, or religious considerations for administration of blood or blood products. This all should be discussed with the surgical team before the patient is brought to the OR. Flowable Hemostatic Agents and Flowable Products Flowable hemostatic agents (Table 5) have both an active and a passive component. The action of these agents is to block blood flow and convert fibrinogen to fibrin at the bleeding site. The passive component of these agents is a bovine or porcine gelatin matrix; thrombin may be included as a component or may be added as an individual item. These agents produce a pasty substance that can be introduced directly on a bleeding area, such as the liver or kidney. These products are commonly used in spine surgery; the surgeon lays the agent along the gutters of the spine to reduce bleeding.1 Flowable products are composite hemostatic agents that use microfibrillar collagen to facilitate tissue healing and achieve hemostasis. Microfibrillar collagen is derived from bovine or porcine sources and requires a “wet” field to be effective, because the presence of blood has mechanical properties that slow or obstruct the flow of blood and thrombin to facilitate the conversion of fibrinogen into fibrin. These products conform easily to the topography of the bleeding area and are easy to apply. Flowable products require reconstitution, and their cost is generally higher than that of mechanical or active products. The safety consideration with these products is that their swelling properties require the surgeon to remove all excess product after hemostasis is achieved.2 HEMOSTATIC AGENTS: A GUIDE TO SAFE PRACTICE www.aornjournal.org TABLE 5. Flowable Hemostatic Agents Indication Localized bleeding Composition/origin Bovine gelatin particles and human thrombin Clinical considerations n n n n n n Localized bleeding Porcine gelatin particles with or without thrombin n n n n n n n Commercial name Should not be used in patients with bovine allergies FLOSEALÒ Risk of swelling Has potential for infection transmission Is approved for use in all specialties except ophthalmology Cannot be used with blood salvage devices or cardiopulmonary bypass equipment Absorbs in 6 to 8 weeks Can be used in combination with RecothromÒ SURGIFLOÒ Should not be used in patients with porcine allergies Risk of swelling Has potential for infection transmission when human thrombin is used Is approved for use in all specialties except ophthalmology Cannot be used with blood salvage devices or cardiopulmonary bypass equipment Absorbs in 4 to 6 weeks FLOSEAL is a registered trademark of Baxter Corporation, Deerfield, IL. Recothrom is a registered trademark of The Medicines Company, Parsippany, NJ. SURGIFLO is a registered trademark of Ethicon, Johnson &Johnson, Inc, Somerville, NJ. Fibrin Sealants Fibrin sealants (Table 6) come in three types: fibrin sealants, polyethylene glycol (PEG) polymers, and albumin with glutaraldehyde. These products form a barrier that is impervious to most liquids. Generally, sealants contain both fibrinogen and thrombin. When the concentrated fibrinogen and thrombin are mixed together, they create a fibrin clot that works by increasing the rate of blood clot formation at the injury site. The product consistency is a thin liquid that can be applied as an aerosol spray. Generally, surgeons use these products in combination with a flowable agent. These are powerful, unique products and have separate FDA approval as hemostats, sealants, and adhesives that are indicated for bleeding control in surgical patients.2 Challenges with these products include reconstitution that may require a trained technician; when using the patient’s blood to reconstitute the product, often the concentration of fibrinogen may be low in the patient’s own blood (eg, fibrinogen concentrations determine the strength of the clot). There is a learning curve for surgeons who use these products, and clinical concerns include blood-related reactions (eg, antibody formation as pooled human thrombin is a major component).4 One product classified in this category, ArtissTM, is not a hemostatic agent. The most common clinical application for this product is to use it to adhere autologous skin grafts to surgically prepared wound beds in both children and adults with burns. The cost is similar to that of other sealants. This product is gas activated and frozen, and it must be thawed. The product can be used up to 14 days after thawing at room temperature. This product is not indicated as an adjunct to other hemostatic agents because it mimics the last stage of the coagulation cascade.15 TachoSilÒ is an absorbable fibrin sealant patch. This product controls local, diffuse bleeding but does not control vigorous bleeding. It can be used as an adjunct to flowables and in patients with coagulopathies or insufficient fibrinogen as well as for skin grafts, dural sealing, bone repairs, splenic injuries, colostomies, and reoperative cardiac surgeries.4 AORN Journal j 141 CAMP August 2014 Vol 100 No 2 TABLE 6. Fibrin Sealants Indication Composition/origin Localized and diffuse bleeding Human plasmaederived fibrin sealant Clinical considerations n n n n n Localized and diffuse bleeding Patient’s own plasma with bovine collagen and thrombin n n n Localized and diffuse bleeding Patient’s own plasma to create fibrinogen and thrombin n n n n Contains pooled human plasma fibrinogen and thrombin Does not need active blood or bleeding; has derived fibrinogen for activation Should not be used with blood salvage devices or cardiopulmonary bypass equipment Has potential for infection transmission Has risks of air embolus, tissue rupture, and gas entrapment Should not be used in patients with bovine allergies Has potential for swelling, infection transmission, foreign body reaction, and immunologic and coagulation risks Is approved for use in all specialties except ophthalmology and neurosurgery Requires a trained technician for processing Should not be used in patients with acquired or hereditary hematologic or coagulation disorders May not be used for patients on active anticoagulants or nonsteroidal agents Clinical studies indicate less effective clot stability than commercially prepared products Commercial name n TISSEELTM EVICELÒ n VitagelTM n CryoSealÒ n TISSEEL is a trademark of Baxter Corporation, Deerfield, IL. EVICEL is a registered trademark of Ethicon, Johnson & Johnson, Inc, Somerville, NJ. Vitagel is a trademark of Stryker, Malvern, PA. CryoSeal is a registered trademark of ThermoGenesis Corporation, Rancho Cordova, CA. Adhesives Typically, the commercial products approved as adhesives (ie, synthetic sealants) are divided into four classes (Table 7): n cyanoacrylates, synthetic skin sealants and tissue sealants, n glutaraldehydes, and n PEG polymers. n They vary in strength and surgical applications; however, each product basically glues tissue together. The adhesive products have a variety of clinical applications and continue to evolve. The products contain minimal amounts of thrombin but have other components that require careful consideration given 142 j AORN Journal their chemical interactions and effect on body tissues. For instance, they cannot be used n in high tension areas such as joints because they will not seal as desired or n on infected or gangrenous tissue, decubiti, or poorly healing wounds because they contain formaldehyde.2 CONCLUSION This article has not covered all products currently available or all of the potential complications or untoward events that may occur when using hemostatic agents. Hemostatic agents are powerful tools in today’s perioperative setting. They allow Cyanoacrylates Synthetic skin sealants Synthetic tissue sealants Glutaraldehydes Polyethylene glycol (PEG) polymers PEG polymers PEG polymers n n n n n Localized applications Localized applications Localized applications Localized applications Localized applications Localized applications Indication PEG polymer and a human blood product PEG polymer and human serum albumin combine to form a gel Polyethylene glycol hydrogels that mix and cross-link at the wound site Glutaraldehyde linked with bovine albumin Monomers form polymers to create a synthetic tissue sealant Liquid monomers Composition/origin n n n n n n n n n n n n n n n n n n n n n n n n n Do not inject Used as a replacement for sutures, primarily on facial, extremity, and torso wounds Attains the strength of healed tissue after 7 days Do not inject Used as an adjunct for vascular reconstruction Mechanically seals a suture or graft line Does not replace sutures, staples, or mechanical closure Do not inject Commonly used in vascular procedures for sealing holes around staple lines Good agent for arterial bleeding Hypersensitivity is a concern Is never absorbed and cannot be reapplied to the same area in the future Do not inject Can prevent pericardial adhesions Good for vascular reconstructions Noninflammatory Infection rates are minimal Should not be used in closed spaces because of product swelling risk Do not inject Aid to prevent cerebrospinal fluid leak Seal dural incisions Sprayed on Contains blue dye for easier identification Do not inject Seals air leaks on lung tissues after the tissue has been sutured or stapled Clinical considerations n n n n n n n n ProgelÒ DuraSealTM CoSealTM BioGlueÒ OMNEXTM DERMABONDÒ SurgiSealÒ LiquiBandÒ Commercial name DERMABOND is a registered trademark and OMNEX is a trademark of Ethicon, Johnson & Johnson, Inc, Somerville, NJ. SurgiSeal is a registered trademark of Adhezion Biomedical, Wyomissing, PA. LiquiBand is a registered trademark of Cardinal Health, Dublin, OH. BioGlue is a registered trademark of CryoLife, Kennesaw, GA. CoSeal is a trademark of Baxter Corporation, Deerfield, IL. DuraSeal is a trademark of Covidien, Boulder, CO. Progel is a registered trademark of NeoMend, Irvine, CA. n n Class TABLE 7. Adhesives (ie, Synthetic Sealants) HEMOSTATIC AGENTS: A GUIDE TO SAFE PRACTICE www.aornjournal.org AORN Journal j 143 CAMP August 2014 Vol 100 No 2 surgeons to control bleeding during operative and other invasive procedures and minimize the need for blood replacement. These products enhance the view of the surgical field, avoid damage to major fragile organs, and can shorten procedure times. They are, however, products that need to be used appropriately. The perioperative nurse needs to be knowledgeable about the use of hemostatic agents; understand what class the agent being requested falls into; and whether the agent is FDA approved, clinically cost-effective, and the most appropriate product for the current situation. This requires vigilance and knowledge on the part of the perioperative nurse to help ensure that the patient is receiving care in a safe environment. 5. 6. 7. 8. 9. 10. 11. 12. Editor’s notes: Artiss is a trademark and TachoSil is a registered trademark of Baxter Corporation, Deerfield, IL. AORN does not endorse any commercial company’s products or services. Although any commercial products that may be referenced in this material are expected to conform to professional medical/nursing standards, inclusion of this material does not constitute a guarantee or endorsement by AORN of the quality or value of such product or of the claims made by its manufacturer. References 1. Lew W, Weaver F. Clinical use of topical thrombin as a surgical hemostat. Biologics. 2008;2(4):593-599. 2. Spotnitz W, Burks S. Hemostats, sealants and adhesives: components of the surgical toolbox. Transfusion. 2008; 48(7):1502-1516. 3. St Peter E, Kneedler J. Hemostasis [AORN Independent Study Guide]. Presented at: AORN Congress; March 2-7, 2013; San Diego, CA. 4. Moss R. Management of Surgical Hemostasis: An Independent Study Guide. Denver, CO: AORN, Inc; 2013. 144 j AORN Journal 13. 14. 15. http://www.aorn.org/search.aspx?searchtext¼Management %20of%20Surgical%20Hemostasis:%20An%20Indepe ndent. Accessed February 26, 2014. Spahn DR, Bouillon B, Cerny V, et al. Management of bleeding and coagulopathy following major trauma: an updated European guideline. Crit Care. 2013;17(R76): 1-53. Bollinger D, Gorlinger K, Tanaka K. Pathophysiology and treatment of coagulopathy in massive hemorrhage and hemodilution. Anesthesiology. 2010;113(5):1-26. Samudrala S. Topical hemostatic agents in surgery: a surgeon’s perspective. AORN J. 2008;88(3):S2-S11. Kaur P, Basu S, Kaur G, Kaur R. Transfusion protocol in trauma. J Emerg Trauma Shock. 2011;4(1):103-108. Ham SW, Lew WK, Weaver FA. Thrombin use in surgery: an evidence-based review of clinical use. J Blood Med. 2010;1:135-142. Overbey DM, Jones EL, Robinson TN. How hemostatic agents interact with the coagulation cascade. AORN J. 2014;100(2):148-159. Di Cera E. Thrombin. Mol Aspects Med. 2008;29(4): 203-254. Spotnitz W, Burks S. Hemostats, sealants, and adhesives II: update as well as how and when to use the components of the surgical toolbox. Clin Appl Thromb Hemost. 2010; 16(5):497-514. Garcia-Roig M, Gorin MA, Castellan M, Ciancio G. OMNEX Surgical Sealant in the extracorporeal repair of renal artery aneurysms. Ann Vasc Surg. 2011;25(8): 1141-1148. Sundaram C, Keenan A. The evolution of hemostatic agents in surgical practice. Indian J Urol. 2010;26(3): 374-378. Australian Public Assessment Report for Fibrin Sealant. Proprietary Product name: Artiss; Sponsor: Baxter Healthcare Pty Ltd. Commonwealth of Australia: Australian Department of Health and Ageing, Therapeutic Goods Administration; October 2010:1-53. Margaret A. Camp, MSN, BSN, RN, is a perioperative consultant in Aurora, CO. Having received money for the development of education programs and for travel, accommodations, and meeting expenses from Ethicon, Ms Camp has declared an affiliation that could be perceived as posing a potential conflict of interest in the publication of this article. EXAMINATION CONTINUING EDUCATION Hemostatic Agents: A Guide to Safe Practice for Perioperative Nurses 3.0 www.aorn.org/CE PURPOSE/GOAL To provide the learner with knowledge specific to the effective management of bleeding during operative and other invasive procedures and the use of hemostatic agents to augment the patient’s natural clotting abilities. OBJECTIVES 1. Discuss why hemostasis is needed during operative and other invasive procedures. 2. Describe the basic mechanisms that naturally occur to promote hemostasis. 3. Discuss the clinical indications for the use of hemostatic agents. The Examination and Learner Evaluation are printed here for your convenience. To receive continuing education credit, you must complete the online Examination and Learner Evaluation at http://www.aorn.org/CE. QUESTIONS 1. 2. 3. What percentage of trauma-related deaths are the result of uncontrolled bleeding? a. 10% b. 20% c. 40% d. 50% The inability to control diffuse venous bleeding can result in a condition known as coagulopathy, which develops because the body is unable to compensate for the rapid consumption and dilution of platelets and coagulation factors during an emergent bleeding episode. a. true b. false The basic mechanisms by which the body attempts to control bleeding include 1. vasodilation. 2. vasoconstriction. 3. the formation of a platelet plug. 4. coagulation. Ó AORN, Inc, 2014 a. 1 and 2 c. 2, 3, and 4 b. 1 and 3 d. 1, 2, and 3 4. Circulating ____________causes the release of additional platelets that initiate the formation of a loose platelet plug. a. prothrombin b. thrombin c. fibrinogen d. lipoproteins 5. Coagulation is a complex body response involving multiple factors and processes that transform liquid blood into a a. glue-like substance. b. cement-like substance. c. gelatin-like substance. d. fibrin-like substance. 6. Passive hemostatic agents 1. are relatively inexpensive and easy to prepare. 2. have no special storage requirements. August 2014 Vol 100 No 2 AORN Journal j 145 CE EXAMINATION August 2014 Vol 100 No 2 should not be used in confined areas of the body under most circumstances. 4. are effective for areas of minimal bleeding. 5. are effective for diffuse capillary or brisk arterial bleeding. 6. do not require the presence of blood for activation and function by interrupting the clotting cascade. a. 3, 5, and 6 b. 1, 2, 3, and 4 c. 1, 2, 4, 5, and 6 d. 1, 2, 3, 4, 5, and 6 3. 7. Hemostasis is provided within 10 minutes by a. injectable hemostatic agents. b. active hemostatic agents. c. topical hemostatic agents. d. mechanical hemostatic agents. 8. Safety is a major consideration for thrombin products, because thrombin acts at the end of the clotting cascade and its interaction is negatively affected by coagulopathies, such as clotting factor deficiencies or platelet malfunction. a. true b. false 146 j AORN Journal 9. The amount of ____________ in a wound can be affected or inhibited by factors such as hemodilution, absorptive sponges, wound irrigation, or continuous wiping or blotting. a. prothrombin b. fibrinogen c. lipoproteins d. thrombin 10. To safely use thrombin-based products, the perioperative nurse must 1. be familiar with the product’s origin and its patient implications. 2. know of any patient allergies. 3. be aware of any patient dietary restrictions. 4. know whether the patient uses anticoagulant or antiplatelet medications or herbal supplements that might affect clotting mechanisms. 5. be aware of any family history of bleeding disorders. 6. know whether the patient has a history of kidney or liver disease. a. 1, 2, 4, and 6 b. 1, 3, and 6 c. 3, 4, 5, and 6 d. 1, 2, 3, 4, 5, and 6 LEARNER EVALUATION CONTINUING EDUCATION PROGRAM Hemostatic Agents: A Guide to Safe Practice for Perioperative Nurses T his evaluation is used to determine the extent to which this continuing education program met your learning needs. The evaluation is printed here for your convenience. To receive continuing education credit, you must complete the online Examination and Learner Evaluation at http://www .aorn.org/CE. Rate the items as described below. OBJECTIVES To what extent were the following objectives of this continuing education program achieved? 1. Discuss why hemostasis is needed during operative and other invasive procedures. Low 1. 2. 3. 4. 5. High 2. Describe the basic mechanisms that naturally occur to promote hemostasis. Low 1. 2. 3. 4. 5. High 3. Discuss the clinical indications for the use of hemostatic agents. Low 1. 2. 3. 4. 5. High CONTENT 4. To what extent did this article increase your knowledge of the subject matter? Low 1. 2. 3. 4. 5. High 5. To what extent were your individual objectives met? Low 1. 2. 3. 4. 5. High 6. Will you be able to use the information from this article in your work setting? 1. Yes 2. No Ó AORN, Inc, 2014 3.0 www.aorn.org/CE 7. Will you change your practice as a result of reading this article? (If yes, answer question #7A. If no, answer question #7B.) 7A. How will you change your practice? (Select all that apply) 1. I will provide education to my team regarding why change is needed. 2. I will work with management to change/ implement a policy and procedure. 3. I will plan an informational meeting with physicians to seek their input and acceptance of the need for change. 4. I will implement change and evaluate the effect of the change at regular intervals until the change is incorporated as best practice. 5. Other: ________________________________ 7B. If you will not change your practice as a result of reading this article, why? (Select all that apply) 1. The content of the article is not relevant to my practice. 2. I do not have enough time to teach others about the purpose of the needed change. 3. I do not have management support to make a change. 4. Other: ________________________________ 8. Our accrediting body requires that we verify the time you needed to complete the 3.0 continuing education contact hour (180-minute) program: ________________________________ August 2014 Vol 100 No 2 AORN Journal j 147
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