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Managing the Coagulopathy of Trauma: Use of Transfusion Protocols and Prohemostatic Agents

Managing the Coagulopathy of Trauma: Use of Transfusion Protocols and Prohemostatic Agents. Faculty. Bryan A. Cotton, MD, MPH The University of Texas Health Science Center Houston, Texas. Richard P. Dutton, MD, MBA University of Maryland School of Medicine R Adams Cowley Shock Trauma Center

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Managing the Coagulopathy of Trauma: Use of Transfusion Protocols and Prohemostatic Agents

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  1. Managing the Coagulopathy of Trauma: Use of Transfusion Protocols and Prohemostatic Agents

  2. Faculty Bryan A. Cotton, MD, MPH The University of Texas Health Science Center Houston, Texas Richard P. Dutton, MD, MBA University of Maryland School of Medicine R Adams Cowley Shock Trauma Center Baltimore, Maryland Martin A. Schreiber, MD, FACS Oregon Health & Science University Portland, Oregon

  3. Hemorrhage • Leading cause of death in first hour of arrival1 • Responsible for more than 80% of OR deaths2 • Accounts for nearly 50% of deaths in first 24 h2 1. Acosta JA, et al. J Am Coll Surg. 1998;186:528-533; 2. Kauvar DS, et al. J Trauma. 2006;60:S3-S11.

  4. How Acute and How Lethal Is the Coagulopathy? • 38% (+) coagulopathic on arrival; mortality (+) coagulopathic 24% (vs 4%)1 • 24% arrive (+) coagulopathic; these patients have higher mortality (46% vs 11%)2 • MT patients, 70% coagulopathic on arrival; mortality in coagulopathic patients 67% (vs 42%) 3 MT=massive transfusion. 1. Niles SE, et al. J Trauma. 2008;64:1459-1465; 2. Brohi K, et al. J Trauma. 2003;54:1127-1130; 3. Cotton BA, et al. J Trauma. 2008;64:1177-1183.

  5. PT: 0.87 BV lost Fibrinogen: 1.14 BV lost Platelets: 1.83 BV lost PT subhemostatic once patient has received only 3.6 U RBCs Preparedness is essential What to Replace? BV=blood volumes. Hirshberg A, et al. J Trauma. 2003;54:454-463.

  6. Why Implement a Protocol? • Many patients arrive with coagulopathy present • An organized protocol to address exsanguinating hemorrhage in the most severely injured patients minimizes delays • Delays in access to appropriate blood products • Delays of sufficient quantities and ratios

  7. Exsanguination Protocol • Surgeon activates trauma exsanguination protocol • (TEP) • Blood bank prepares first round of products • 10 U RBC • 6 U plasma • 2 apheresis platelets • Blood bank begins preparation of next round of • products • 6 U RBC • 4 U plasma • 2 apheresis platelets Cotton BA, et al. J Trauma. 2008;64:1177-1183.

  8. Exsanguination Protocol • Unless specified, blood bank releases second box and ceases preparation of future boxes • Surgeon notifies blood bank and stops TEP if • Hemostasis achieved • Case completed • Patient expires Cotton BA, et al. J Trauma. 2008;64:1177-1183.

  9. Damage Control Resuscitation • Damage control hematology: the impact of a trauma exsanguination protocol on survival and blood product utilization • (Cotton et al. Journal of Trauma, 2008) • Three components • Hematologic • Limited crystalloid • Permissive hypotension Cotton BA, et al. J Trauma. 2008;64:1177-1183.

  10. Improved Survival • 74% reduction in the odds of mortality • Increase in unexpected survivors • Decrease in unexpected deaths • Less intraoperative crystalloid; fewer postoperative blood products Cotton BA, et al. J Trauma. 2008;64:1177-1183.

  11. Higher Ratios • Mortality reduction attributed to empiric delivery of higher, predefined ratios of plasma and platelets1 • Higher fibrinogen (plasma):RBC ratio independently associated with improved survival2 • Higher plasma and platelet ratios improved survival in MT patients1 1. Gunter OL Jr, et al. J Trauma. 2008;65:527-534; 2. Stinger HK, et al. J Trauma. 2008;64(2 suppl):S74-S85.

  12. Predefined MT Protocols • Predefined massive transfusion protocols are • associated with a reduction in organ failure and postinjury complications • (Cotton et al. Journal of Trauma, 2009) • MT historically associated with higher rates • of organ failure and postinjury complications • Risk reduced with early delivery of blood • products through predefined protocol MT=massive transfusion. Cotton BA, et al. J Trauma. 2009;66:41-49.

  13. Predefined MT Protocols • Implementation of protocol results in • Reduction in MOF • Fewer pulmonary issues • Reduced incidence of open abdomens in • compartment syndrome MOF=multiorgan failure. Cotton BA, et al. J Trauma. 2009;66:41-49.

  14. MLR Analysis for 30-Day Survival

  15. rVIIa: Adjuvant for treatment of coagulopathy in patients with severe torso hemorrhage rVIIa: Binds tissue factor at site of endothelial injury, triggering local coagulation process rVIIa: Reduces incidence/severity of coagulopathy in severely injured patients with ongoing transfusions Recombinant Factor VIIa (rVIIa) Martinowitz U, et al. J Trauma. 2001;51:431-438; Rizoli SB, et al. Crit Care. 2006;10:1-11; Stein DM, et al. J Trauma. 2008;64:620-627.

  16. Several OIF/OEF studies showed improved outcomes1,2 Phase II trauma study of rVIIa demonstrated a reduction in RBC use, trend toward less MOF3 Potentially limited with acidosis and thrombocytopenia4,5 Reports of thromboembolic adverse events6 Recombinant Factor VIIa (rVIIa) 1. Perkins JG, et al. J Trauma. 2007;62:1095-1099; 2. Spinella PC, et al. J Trauma. 2008;64:286-294; 3. Boffard KD, et al. J Trauma. 2005;59:8-15; 4. Martini WZ, et al. Ann Surg. 2007;246:831-835; 5. Stein DM, et al. J Trauma. 2005;59:609-615; 6. O’Connell KA, et al. JAMA. 2006;295:293-298.

  17. Recent Studies: rVIIa • Stein et al. Injury (2008) • Objective: Examine safety and efficacy of rVIIa • for reversing mild to moderate coagulopathy • Retrospective review, 2004-2006 • Results: Decreased utilization of PRBCs and • FFP; lower vol fluid administration; rapid • reversal of coagulopathy Stein DM, et al. Injury. 2008;39:1054-1061.

  18. Recent Studies: rVIIa • Horton et al. Am Surg (2008) • Objective: Examine frequency and patterns of • rVIIa use since Jan 2005 • Survey of 156 US trauma centers, level I and II Horton JD, et al. Am Surg. 2008;74:413-417.

  19. PCC: Clotting factors (II, VII, IX, and X) that can be used to reverse coagulopathy PCC: Effects are fast and long acting PCC: Use in trauma patients appears safe and beneficial in critically injured population Associated with thrombogenicity Prothrombin Complex Concentrate (PCC) Kalina M, et al. Am Surg. 2008;74:858-861; Köhler M. Thromb Res. 1999;95(4 suppl):S13-S17; Riess HB, et al. Thromb Res. 2007;121:9-16.

  20. Recent Studies: PCC • Dickneite et al. Br J Anaesth (2009) • Objective: Compare effects of PCC and FFP • on hemorrhage after injury and impact of both agents on coagulation function in vivo • Porcine trauma model: 47 castrated male pigs • Results: PCC, not FFP, reversed hemodilution effects Dickneite G, et al. Br J Anaesth. 2009.

  21. Recent Studies: PCC • Riess et al. Thromb Res (2007) • Objective: Examine efficacy of PCC for • reversing anticoagulant effects • 60 patients with bleeding complications • or undergoing invasive procedures • Result: Rapid and safe reversal of • anticoagulation with PCC Riess HB, et al. Thromb Res. 2007;121:9-16.

  22. Question-and-Answer Session

  23. Bryan A. Cotton, MD, MPH Associate Professor of Surgery The University of Texas Health Science Center and Center for Translational Injury Research Houston, Texas

  24. What are your thoughts concerning recombinant factor VIIa data, including studies indicating that the agent may reduce transfusion requirement but have no effect on ultimate outcome?

  25. Availability of recombinant factor VIIa when unable to get surgical control • Medivac helicopters • Fluid replacement to avoid hemodilution • Smaller-volume trauma centers • No in-house trauma surgeon • Delivered with the second box of product

  26. Timing of use • Protracted wait = poor outcome • Have agent ready early enough but not too early

  27. Martin A. Schreiber, MD, FACS Oregon Health & Science University Portland, Oregon

  28. From your perspective, how has recombinant factor VIIa evolved as an off-label drug to treat the coagulopathy of trauma?

  29. Evolution of rVIIa use • Previously misused based on improper patient care • Crystalloid and blood products • Used as rescue drug to counter cycle of coagulopathy • Current recognition of coagulopathy on admission • Need for resuscitation with high ratios of plasma to platelets Replacement Therapy • Fell behind • Still evolving

  30. Richard P. Dutton, MD, MBA Professor of Anesthesiology University of Maryland School of Medicine Attending Anesthesiologist R Adams Cowley Shock Trauma Center Baltimore, Maryland

  31. Which of the treatment strategies that are just beginning to be recognized for the coagulopathy of trauma do you believe will be routinely performed 5 years from now?

  32. Better testing of coagulation early • Individual factor therapy • Combinations of factor therapy • Fibrinolytic mechanism • Use of deep anesthesia

  33. Thank you for participating in this CE activity. To receive credit for this activity, please complete the posttest and evaluation by clicking the “posttest” tab located above and following the instructions. To download the reference list or supplemental slides for this program, please click the appropriate link on the home page of this activity. www.bloodcmecenter.org

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