ACS TQIP MASSIVE TRANSFUSION IN TRAUMA GUIDELINES

Released October 2014 Table of Contents

Introduction...... 3

Development of a Massive Transfusion Protocol: Engagement and Scope...... 3

Triggers for Initiating Massive Transfusion...... 4

Blood Product in the Trauma Bay, Operating Room, and Angiography Suite...... 5

Massive Transfusion in the Intensive Care Unit ...... 6

Operational Aspects of the Transfusion Service/ Bank...... 6

Endpoints of Transfusion...... 8

Therapeutic Adjuncts in Massive Transfusion...... 10

Monitoring System Performance in Massive Transfusion...... 11

Bibliography...... 13

Expert Panel...... 15

Disclaimer...... 16

2 Introduction Development of a

Hemorrhage is the most common cause Massive Transfusion of death within the first hour of arrival to Protocol: Engagement a trauma center. More than 80 percent of deaths in the operating room (OR) and Scope and nearly 50 percent of deaths in the An MTP should be a written document, first 24 hours after injury are due to accessible to all, and adopted by the exsanguination and coagulopathy. While center. All staff should be familiar only 3 percent of civilian trauma patients with the procedures. Initial training will receive a massive transfusion (>10 and subsequent regular drills are units red blood cells [RBC] in 24 hours), recommended to maintain competency. these patients consume 70 percent of This process is especially important in all blood transfused at a trauma center. trauma centers where MTP initiations are Because massive transfusions are rare, for example, smaller centers. The unplanned and require the processing content of MT protocols should be based and delivery of large amounts of blood on the principles of damage control products rapidly for a sustained period resuscitation. As such, they should of time, significant preplanning and provide for ratio-based blood products coordination between the , that are empirically delivered (hemostatic the emergency department, the OR, resuscitation) and have a process for and delivery personnel is required. The the immediate availability of RBC, development and implementation of plasma, and . Protocols should massive transfusion protocols (MTPs) also include standardization of the have been associated with a reduction assessment of coagulopathy and include in mortality and overall assessment and treatment of acidosis, use in trauma centers. The purpose of hypothermia, and hypocalcemia. the following guidelines is to identify the necessary components of an MTP Massive transfusion protocols should and address key issues involved in be developed by a multidisciplinary developing an MTP for trauma. committee that includes, at a minimum, representatives from:

zz Transfusion service/blood bank

zz Emergency department

zz Anesthesia

zz Trauma service

3 The massive transfusion protocol respectively, with specificities that range should address: between 80 percent and 90 percent. One well-validated scoring system is zz Triggers for initiating massive the Assessment of Blood Consumption transfusion in trauma (ABC) score. The ABC score consists zz Resuscitation in the trauma of four variables (pulse >120, SBP<90, bay, including: + FAST, and penetrating torso injury), each assigned one point. A score of two MTP product availability or more warrants MTP activation. The MTP product delivery ABC score overestimates the need for transfusion, with a positive predictive MTP blood product transfusion value of 50 percent to 55 percent, zz Continuing MTP in the OR, meaning that 45 percent to 50 percent angiography suite, and intensive of patients in whom MTP is activated will care unit not need a massive transfusion. However, the ABC score is excellent at identifying zz Transfusion service processes for who will not need massive transfusion, delivery of blood products with a negative predictive value of less zz Transfusion targets than 5 percent, meaning it identifies more than 95 percent of all patients zz The use of adjuncts for massive who will need a massive transfusion. transfusion patients Other prediction scores have been developed and all include the presence zz Termination of the MTP of severe tissue injury and hemorrhagic zz Performance improvement as important risk factors. monitoring Criteria to trigger the activation of an MTP should include one or more of the following:

Triggers for Initiating zz ABC score of two or more Massive Transfusion zz Persistent hemodynamic instability Predicting the need for MT is difficult. z Mortality is improved with rapid z Active requiring activation of a massive transfusion operation or angioembolization protocol, but complications are increased zz in the trauma bay if patients have unnecessary exposure to blood products. Prediction tools for MT in adult trauma patients have been developed for both military and civilian trauma patients with injuries from penetrating or blunt trauma,

4 zz Transfuse universal RBC and plasma Blood Product in a ratio between 1:1 and 1:2 (plasma Resuscitation in the to RBC). Trauma Bay, Operating zz Transfuse one single donor or random donor pool for Room, and Angiography each six units of RBC.

Suite zz Blood products should be Universally compatible RBC (O Rh- automatically sent by the transfusion negative and O Rh-positive) and service in established ratios. thawed plasma should be immediately zz Subsequent coolers should be available and ideally stored in the delivered at 15-minute intervals until emergency department (ED). Centers the MTP has been terminated. that have used thawed plasma early in resuscitation have seen reductions zz The goal is to keep at least one MTP in blood product utilization and cooler ahead for the duration of the product wastage. In areas where the MTP activation. transfusion service is unable to provide When the patient is moved from the adequate stores of AB plasma, low resuscitation suite to the operating (anti-B) titer A plasma may be utilized. room or the angiography suite it is For maximum effectiveness, damage important that this is communicated to control resuscitation (DCR) principles the Transfusion Service so that blood suggest that RBC and plasma should product delivery can continue to the site be delivered by a rapid transfuser and of patient care. During the procedure through a blood warmer. Initial rate of rapid delivery and transfusion of transfusion should restore perfusion but products should continue in appropriate allow for permissive hypotension until ratios and at a rate to keep maintain the operation or angioembolization to adequate blood volume while the patient stop the bleeding has begun. Platelets is actively bleeding. Once major bleeding and should not be has been controlled and the rate of administered through a blood warmer. transfusion has slowed it is appropriate to switch to a laboratory-or point of zz Universal blood products should be care (POCT)-based transfusion. For immediately available on patient performance improvement purposes the arrival to support ratio-based ratio of blood product transfusion should transfusion. be assessed at the time of bleeding If MTP triggers are met: cessation and not necessarily at a specific time point or at the end of an operation zz Begin universal blood product or angioembolization. infusion rather than crystalloid or colloid solutions.

5 Ionized calcium

Massive Transfusion in Blood gas analysis, including the Intensive Care Unit base deficit

Trauma patients for whom a massive zz Use of empiric fixed ratios of blood transfusion protocol is activated most products should be followed in the frequently require intensive care. ICU until bleeding is controlled and/ Arrival of these patients to the intensive or specific laboratory and POCT data care unit (ICU) marks an important are available. These products should checkpoint, including a systematic be delivered in a ratio between 1:1 review of the patient’s prior resuscitative and 1:2 (plasma:RBC). efforts. The ICU accepting team should zz Once laboratory data are available, anticipate arrival of these patients with resuscitation should be goal directed the necessary equipment to continue based on the laboratory findings rapidly infusing blood products. and clinical evidence of ongoing Attention should be paid to correcting bleeding. factors that exacerbate coagulopathy, including hypothermia, acidosis, and hypocalcemia. If massive ongoing bleeding persists, the patient may require Operational Aspects of prompt return to the operating room, particularly if the status has the Transfusion Service/ been normalized. Blood Bank

An appropriate ICU-driven algorithm A designated trauma center should should be optimized to use blood have an on-site transfusion service components for goal-directed therapy. that operates 24 hours a day, seven days a week and has specific operating zz Upon arrival in the ICU, baseline procedures for the rapid early and laboratory measures should be continued delivery of blood components obtained and then repeated as as dictated by an MTP. The MTP must needed or at least hourly: allow adherence to current, standard INR safe practices for transfusion. During massive transfusion, timely and precise aPTT communication between the trauma  level team, the ED, the operating room, anesthesia, and the transfusion service Hemoglobin or hematocrit regarding availability and need for transfusion products is imperative. Platelet count

Point-of-care testing/ thromboelastometry and rotational thromboelastography, if available

6 The most efficient way to immediately of RBC with short storage times to the initiate an MTP is to have a blood trauma patient at the expense of other refrigerator containing universal donor patients. The RECESS and ABLE studies products in the resuscitation bay. Rapid that are underway in the U.S. and Canada delivery of subsequent blood coolers may give further guidance in the future. from the transfusion service to the For an MTP to be effective, universal resuscitation bay is best accomplished thawed plasma should be immediately by the assignment of a dedicated available. This step can be accomplished runner. A process must be in place to by storing thawed or liquid (never frozen) rapidly deliver a group and screen to plasma. The ideal universal plasma is AB the transfusion service laboratory to plasma, but unfortunately it is in short facilitate the availability of crossmatched supply, as only 4 percent of donors have RBC. Uncrossmatched (O Rh negative or this . As a result of increased O Rh positive RBC) should be available use of AB plasma in resuscitation, immediately. Group O Rh negative shortages of plasma may occur for RBC should be reserved for women of patients with AB blood type. However, 40 child-bearing potential (younger than percent of donors are type A and many 45 to 50 years old). Patients should of them have low titers of anti-B; this low be switched to crossmatched RBC as titer plasma can be safely given to almost soon as it is available, which should be everyone. In order to avoid overuse achievable within one hour for most or wastage of AB plasma, transfusion patients (about 97 percent). For a small services may utilize group A plasma with number of patients who have a positive low anti-B titers. This process requires screen, obtaining crossmatched determining anti-B titer at the time of RBC may take hours. Staffing the donation. Patients should be switched transfusion service with technologists to group-specific plasma as soon as trained in antibody investigations is the blood group has been determined, instrumental for providing these patients which usually takes about 10 minutes. with compatible RBC. A transfusion The transfusion service should maintain medicine specialist should be available to a sufficient quantity of platelets to consult with the trauma team regarding support ratio-based massive transfusion. compatibility and other issues related to Additional platelets may be needed to massive transfusion. support patients with bleeding disorders Currently RBC can be safely stored for up or those on antiplatelet therapy. Blood to six weeks and are released using a first- products should be transported and in, first-out system to minimize wastage. stored appropriately. RBC and plasma While there is concern that transfusion of should be delivered and kept in RBC with longer storage times in trauma temperature-controlled coolers. Platelets may increase complications, there is no and cryoprecipitate should not be placed current justification to prioritize the use in coolers. Upon termination of MTP, all remaining blood products and coolers should be returned to the transfusion service promptly.

7 In multicasualty situations, especially zz Special consideration for universal when patients are poorly identified, the product use should be given only in transfusion service should be notified multicasualty situations immediately, and consideration should be given to exclusive use of universal donor blood products until stable identities or aliases can be established. Endpoints of Transfusion

A designated trauma center or its To ensure that the MTP protocol does not supporting transfusion service needlessly waste scarce resources, it is should have on hand and available important to determine the criteria and for immediate release the following: process for termination of the protocol. Based on guidelines for enrollment in the At least eight units of universal current Pragmatic, Randomized Optimal donor, uncrossmatched RBC Platelets and Plasma Ratios (PROPPR) (for example, four units of O Rh study, criteria for stopping the MTP negative RBC and four units of should include both anatomic (control O Rh positive RBC) of bleeding) and physiologic criteria At least eight units of thawed (normalizing hemodynamic status). The group AB or low titer anti-B group decision to stop should be made by the A plasma. Additional plasma trauma surgeon in conjunction with the should be obtainable from the anesthesiologist, if the patient is still in transfusion service within 15 the operating room, or the intensivist/ minutes of MTP activation. trauma surgeon if in the ICU.

zz Uncrossmatched blood products In addition, the exact laboratory value should be delivered until group- endpoints that should be used to guide matched products are available. further blood product use should be based on published data and the Once the transfusion service has extensive clinical experience of those received a blood specimen for who are caring for the patient. group matching, group-matched products should be available zz The ratio-driven massive transfusion within 10 minutes. may be discontinued or downgraded to goal-directed transfusion based Crossmatched RBC should on the laboratory findings if surgical be available within one hour bleeding has been controlled by the for most patients. Notable surgeon in the operating room OR rare exceptions include RBC there is radiographic and physiologic alloantibody, rare blood group, evidence of bleeding control after and so on. angioembolization.

8 zz The MTP should be discontinued If rapid TEG is available, the following when there is recognition that cut-points for transfusion triggers may further resuscitation is futile. also be used:

zz The following should be used as zz Plasma for ACT >128 seconds guides to cease therapy with blood zz Plasma and/or cryoprecipitate and blood components in a patient (fibrinogen concentrate) for k-time who is (1) not actively bleeding and >2.5 minutes (2) still in the acute resuscitation phase: zz Cryoprecipitate (fibrinogen concentrate) and/or plasma for zz RBC transfusions for hemoglobin α-angle <60o ≥10 g/dL zz Platelets for mA <55 mm zz Plasma transfusion for prothrombin time (PT) <18 seconds zz Anti-fibrinolytics for LY30 >3 percent

zz Plasma transfusion for activated If rotational thromboelastometry partial thromboplastin time (aPTT) (ROTEM®) is available, the following <35 seconds cut-points for transfusion triggers may also be used: zz Platelet transfusions for platelet 9 count >150 x10 zz Plasma for CT exTEM>100 seconds and/or CT inTEM>230seconds zz Cryoprecipitate or fibrinogen concentrate for fibrinogen level zz Cryoprecipitate (fibrinogen >180 g/L concentrate) and/or plasma for MCF fibTEM<8mm If standard thrombelastography (TEG®) is available, the following zz Platelets for MCF exTEM<45mm and cut-points for transfusion triggers MCF fibTEM>10mm may also be used: zz Anti-fibrinoolytics for ML exTEM>15 zz Plasma for r-value >9 minutes percent zz Plasma and/or cryoprecipitate (fibrinogen concentrate) for k-time >4 minutes

zz Cryoprecipitate (or fibrinogen concentrate) and/or plasma for α-angle <60o

zz Platelets for mA <55 mm

zz Anti-fibrinolytics for LY30 >7.5 percent

9 For the purposes of reporting and documentation in registry and Therapeutic Adjuncts in databases, hemorrhage control/ hemostasis can be declared when Massive Transfusion both of the following have been met: There are several adjuncts available for zz The surgeon declares hemostasis massive transfusion. Antifibrinolytic based on the absence of bleeding medications, such as tranexemic acid requiring intervention in the surgical (TXA) or aminocaproic acid, inhibit field OR resolution of blush after plasminogen activation and plasmin angioembolization. activity thus stabilizing the clot. Although available and widely used for zz The surgeon and/or anesthesiologists many years, it was not until the Clinical agree that the patient is adequately Randomization of an Antifibrinolytic in resuscitated based on the following Significant Hemorrhage-2 (CRASH-2) criteria, if available: trial that the use of TXA in trauma was examined. Tranexemic acid Stable or increasing has been shown to be effective in a blood pressure, or variety of surgical settings, including Stable or decreasing heart rate, or cardiovascular surgery, orthopaedic Stable or increasing surgery, postpartum hemorrhage, and urine output, or trauma. In trauma, antifibrinolytic agents can be used empirically or in response to Decreasing requirement for findings of increased fibrinolytic activity vasopressors to maintain a stable on POCT. blood pressure Frequent communication between Recombinant activated factor VIIa was the members of the resuscitation initially developed for the treatment of and surgical teams cannot be hemophilia with inhibitors and is only overemphasized to guide the licensed by the U.S. Food and Drug resuscitation, plan for continued need Administration (FDA) for this indication. for blood products and adjuncts, and However, over the last decade, it has determination of when to move toward been studied and has been used in data-based resuscitation and when to the setting of traumatic coagulopathy end active resuscitation. as well as reversal of warfarin-induced anticoagulation in serious bleeding. At this time, the role of factor VIIa is unclear. It certainly appears to reduce transfusion requirement, but lack of long-term mortality benefit and potential increases in morbidity have placed its position in the MTP in doubt.

10 A variety of prothrombin complex concentrates are currently available. Monitoring System These concentrates contain either three (II, IX and X) or four (II, VII, IX and Performance in Massive X) clotting factors. Although widely Transfusion available in Europe and elsewhere for years, the first FDA-approved four-factor Acute hemorrhage associated with PCC has just been released in the United traumatic injury places the patient States. This product is licensed for urgent at risk for a myriad of complications. reversal of warfarin but is sometimes Review of hemorrhage- and transfusion- used off-label for management of related complications, along with trauma-induced coagulopathy in Europe. monitoring of the availability and management of blood products during zz TXA 1 gram intravenous over 10 massive transfusion, can help identify minutes followed by infusion opportunities for improvement in the MT of 1 gram over eight hours is process. recommended in all injured patients who are actively bleeding and are The trauma center should review within three hours of injury. cases of massive transfusion with the following complications: zz PCC is currently only approved for z correction of warfarin-induced z Coagulopathy coagulopathy in bleeding patients. zz Thrombotic complications As such, the American College of Chest Physicians Guidelines, zz ARDS 9th Edition, recommends use of zz Other transfusion reactions, including PCC over FFP for warfarin reversal in TACO (transfusion-associated volume the setting of major bleeding. overload), TRALI (transfusion-related zz Recombinant VIIa is generally not acute lung injury), and hemolytic recommended for management of transfusion reaction refractory hemorrhage in trauma. zz Over-transfusion of RBC

zz Death

11 Performance indicators for the process of massive transfusion should include:

zz Time from calling MTP to infusion of first unit RBC

zz Time from calling MTP to infusion of first unit plasma

zz Adherence to a predetermined ratio or goal between one to two hours after initiation of the MTP

zz Informing the transfusion service that MTP has been terminated within one hour of termination

zz Wastage rates for blood products

12 Riskin DJ, Tsai TC, Riskin L, et al. Massive transfusion protocols: The role of aggressive resuscitation versus Bibliography product ratio in mortality reduction. J Am Coll Surg. 2009;209(2):198-205.

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Dente CJ, Shaz BH, Nicholas JM, et al. Improvements in early mortality and coagulopathy are sustained better Blood Product Resuscitation in patients with blunt trauma after institution of a in the Trauma Bay, Operating massive transfusion protocol in a civilian level I trauma center. J Trauma. 2009;66(6):1616-1624. Room, and Angiography Suite Wehrli G, Taylor NE, Haines AL, Brady TW, Mintz PD. Instituting a thawed plasma procedure: It just makes Development of a Massive sense and saves cents. Transfusion. 2009;49(12): Transfusion Protocol: 2625-2630. Engagement and Scope Radwan ZA, Bai Y, Matijevic N, del Junco DJ, McCarthy JJ, Wade CE, Holcomb JB, Cotton BA. An emergency Sauaia A, Moore FA, Moore EE, et al. Epidemiology of department thawed plasma protocol for severely trauma deaths: A reassessment. J Trauma. 1995;38:185-193 injured patients. JAMA Surg. 2013;148(2):170-175. Cotton BA, Gunter OL, Isbell J, et al. Damage control hematology: The impact of a trauma exsanguination protocol on survival and blood product utilization. J Trauma. 2008;64(5):1177-1182

13 Zielinski MD, Johnson PM, Jenkins D, Goussous N, replace conventional coagulation tests in the emergency Stubbs JR. Emergency use of prethawed group A department: Experience with 1974 consecutive trauma plasma in trauma patients. J Trauma Acute Care Surg. patients. Ann Surg. 2012;256(3):476-486. 2013;74:69-75. Cotton BA, Cohen MJ, Camp E, Welch T, Redick B, Sticke Armand R, Hess JR. Treating coagulopathy in trauma R, Podbielski J, Holcomb JB, Schreiber MA. A multicenter patients. Transfus Med Rev. July 2003;17(3):223-231. study of rapid thrombelastography in predicting large volume transfusions. Presented at the 71st Annual Meeting of AAST and Clinical Congress of Acute Care Massive Transfusion in the Surgery, Kauai, HI; September 12-15, 2012. Intensive care Unit Holcomb JB, del Junco DJ, Fox EE, Wade CE, Cohen Westbrook AJ, et al. Protocol based on MJ, Schreiber MA, Alarcon LH, Brasel KJ, Bulger EM, thromboelastograph (TEG) out-performs physician Cotton BA, Matijevic N, Muskat P, Myers JG, Phelan HA, preference using laboratory coagulation tests to guide White CE, Zhang J, Rahbar MH for the PROMMTT Study blood replacement during and after cardiac surgery: A Group. The Prospective, Observational, Multicenter, pilot study. Heart Lung Circ. 2009;18(4):277-288. Massive Transfusion study, PROMMTT: Comparative effectiveness of a time-varying treatment and Royston D, von Kier S. Reduced hemostatic competing risks. JAMA Surg. 2013;148(2):127-136. factor transfusion using heparinase-modified thrombelastography during cardiopulmonary bypass. Kashuk JL, Moore EE, Sawyer M, et al. Post injury Br J Anaesth. 2001;86(4):575-578. coagulopathy management: goal directed resuscitation via POC thrombelastography. Ann Surg. 2010;251:604-614. Ak K, et al. Thromboelastography-based transfusion algorithm reduces blood product use after elective Pezold M, Moore EE, Wohlauer M, et al. Viscoelastic clot CABG: A prospective randomized study. J Card Surg. strength predicts coagulation-related mortality within 2009;24(4):404-410. 15 minutes. Surgery. 2012;151:48-54.

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Antithrombotic Therapy and Prevention of Thrombosis. 9th Endpoints of Transfusion ed. American College of Chest Physicians Evidence-Based Pragmatic, Randomized Optimal Platelets and Plasma Clinical Practice Guidelines. February 2012;141(2_suppl). Ratios (PROPPR). Available at: http://clinicaltrials.gov/ show/NCT01545232. Accessed March 28, 2013.

Holcomb JB, Minei KM, Scerbo ML, Radwan ZA, Wade CE, Kozar RA, Gill BS, Albarado R, McNutt MK, McCarthy JJ, Cotton BA. Admission rapid thrombelastography (r-TEG) can

14 Expert Panel H. Gill Cryer, MD, FACS (Chair) Rosemary Kozar, MD, FACS Professor of Surgery, Trauma/Emergency Surgery Professor of Surgery and Chief of Trauma, Memorial and Critical Care Program, UCLA, Los Angeles, CA Hermann Hospital, Houston, TX

Avery B. Nathens, MD, FACS Joseph Minei, MD, FACS Professor of Surgery, University of Toronto, Surgeon Professor of Surgery and Chief, Division of Burn, in Chief of Department of Surgery, Sunnybrook Trauma, and Critical Care, University of Texas Hospital, Toronto, ON Southwestern Medical Center, Dallas, TX

Eileen M. Bulger, MD, FACS Katerina Pavenski, MD, FRCPC Professor of Surgery and Chief of Trauma, University of Assistant Professor, Departments of Medicine and Washington, Harborview Medical Center, Seattle, WA Laboratory Medicine and Pathology, University of Toronto, Toronto, ON J. Forrest Calland, MD, FACS Assistant Professor of Surgery, University of Virginia Martin Schreiber, MD, FACS Health System, Charlotte, VA Professor of Surgery and Director of Trauma, Oregon Health & Science University, Portland, OR Mitchell J. Cohen, MD, FACS Assistant Professor of Surgery, Division of General Philip C. Spinella, MD, FCCM Surgery, University of California, San Francisco, CA Associate Professor of Pediatrics and Director, Critical Care Translational Research Program, Washington Bryan A. Cotton, MD, FACS, MPH University, St. Louis, MO Associate Professor of Surgery, Division of Acute Care Surgery Department of Surgery, University of Texas, Angela M. Ingraham, MD Houston, TX Critical Care Medicine Fellow, University of Pittsburgh, PA Matthew L. Davis, MD, FACS Assistant Professor of Surgery, Texas A&M COM, Hunter B. Moore, MD Trauma Program Director, Scott and White Integrated Research Fellow, University of Colorado Healthcare System, Temple, TX RAS Liason to ACS Committee on Trauma

Mark R. Hemmila, MD, FACS Associate Professor of Surgery, University of Michigan Health Systems, Ann Arbor, MI

John R. Hess, MD, MPH, FACP, FAAAS Professor of Laboratory Medicine, University of Washington, Seattle, WA

Randeep Jawa, MD, FACS, FCCM Visiting Associate Professor of Surgery, Division of Trauma, Emergency Surgery, and Surgical Critical Care, Stony Brook University School of Medicine, Stony Brook, NY

15 The intent of the ACS TQIP Best Practices Guidelines is to provide health care professionals with evidence-based recommendations regarding care of the trauma patient. The Best Practices Guidelines do not include all potential options for prevention, diagnosis, and treatment and are not intended as a substitute for the provider’s clinical judgment and experience. The responsible provider must make all treatment decisions based upon his or her independent judgment and the patient’s individual clinical presentation. The ACS shall not be liable for any direct, indirect, special, incidental, or consequential damages related to the use of the information contained herein. The ACS may modify the TQIP Best Practices Guidelines at any time without notice.

16 Notes

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