Presentation is loading. Please wait.

Presentation is loading. Please wait.

Saving Lives By Strengthening Our Region’s Trauma Care System Management of Trauma Hemorrhage: Possible Role of Kcentra, a 4-factor Prothrombin Complex.

Similar presentations


Presentation on theme: "Saving Lives By Strengthening Our Region’s Trauma Care System Management of Trauma Hemorrhage: Possible Role of Kcentra, a 4-factor Prothrombin Complex."— Presentation transcript:

1 Saving Lives By Strengthening Our Region’s Trauma Care System Management of Trauma Hemorrhage: Possible Role of Kcentra, a 4-factor Prothrombin Complex Concentrate Joli Dace, PharmD, BCPS Mercy Hospital and Trauma Center

2 2 Objectives Define PCC Differentiate PCCs available in US Identify action in coagulation cascade Compare Kcentra with FFP Review use of Kcentra in trauma: Emergent reversal of oral anticoagulants Management of trauma hemorrhage Discuss Kcentra nursing considerations

3 3 What are PCCs? Prothrombin complex concentrates Concentrated clotting factors derived from pooled human plasma PCC Products Available in US Therapeutic Clotting Factors Alternative Names Profilnine SD ® II, IX, X 3f-PCC Kcentra ® II, IX, X, VII 4f-PCC BeriPlex ® P/N (outside US) Feiba ® NFII, IX, X, aVII Activated 4f-PCC Factor VIII Inhibitor Bypassing Activity

4 Coagulation Cascade Tanaka KA, Key NS, Levy JH. Blood Coagulation: Hemostatis and Thrombin Regulation. Anesth Analg. 2009;108:1433-46.

5 5 Comparison: Kcentra and FFP 3-6,18 Kcentra ® FFP Clotting Factors II, VII, IX, XII, V, VII – XIII; fibrinogen Anticoagulants AT, heparin, protein C & Sprotein C & S Preparation Dilute each vial with 20mL Thaw ; ABO match Volume Average 40 -100 mL/doseAverage 30 mL/kg Administration Rate Weight-based (~8-20min) 7x faster than FFP 3 Each unit over 30-60 min Considerations Less volume and faster administration = faster restoration of factor levels 3 Dilutional coagulopathy Risk of transfusion-related acute lung injury

6 6 Emergent Warfarin Reversal 2,3,4,7 Acute major bleed (head, spine, uncontrolled GI, extremity with risk of compartment syndrome) or Urgent surgery or invasive procedure within 6h 2 INRReversal ≤ 1.5vitamin K 5 - 10 mg IV STAT 1.6 – 1.9 vitamin K + FFP 2.0 – 3.9 vitamin K + Kcentra 25 un/kg (max 2500 un) 4.0 – 6.0 vitamin K + Kcentra 35 un/kg (max 3500 un) > 6.0 vitamin K + Kcentra 50 un/kg (max 5000 un) For non-emergent warfarin reversal, see 2012 Chest Guideline vitamin K recommendations 7.

7 7 Emergent NOAC (Novel Oral Anticoagulants) Reversal Strategies 8-12 NOAC Drug Class Factor Xa InhibitorsDirect Thrombin (IIa) Inhibitor NOAC Agents apixaban (Eliquis) rivaroxaban (Xarelto) dabigatran (Pradaxa) Coagulation Testsanti-Xa, PT, aPTTECT, dilute TT, aPTT Activated Charcoal?Yes, if last dose < 2h ago. Hemodialysis?Not useful.Yes – prolonged (2h+) PCC to reverse? Kcentra 25 – 50 un/kg Alternative Reversals? ? FEIBA 25 un/kg 10 aDabi-Fab (future) 11

8 8 Management of Trauma Hemorrhage – Standards of Care 16 Consider TXA early (bleeding or at risk) Correct hypothermia, acidosis, hypotension Maintain Hgb (7-9 g/dL), plts (50-100k) Fibrinogen – maintain > 1.5 – 2 mg/dL 19 Depleted earlier than blood factors at 142% blood loss vs. 200-240% before fII, fVII critically low 13 Risk factors for low fibrinogen level on admission 14 : injury severity score, shock, SBP<90, prehospital fluid volume Calcium – maintain iCa > 0.9 20

9 9 PCC in Trauma Hemorrhage Evidence-supported benefit? Lack of prospective trials demonstrating mortality benefit Retrospective reports demonstrate decreased INR, bleeding, need for PRBCs, stabilized blood pressure 22-25 Guidelines differ 16,17 ; local use positive Thrombosis risk: low (0-1.4% for current 4fPCCs) Exclusion criteria: DIC, HIT optimal Kcentra dose: unclear. (?25-50 un/kg; max 100kg) Possibly consider Kcentra for: Massive hemorrhage unresponsive to conventional tx TEG-guided: ongoing bleed with CT > 90s 15 Hgb-driven “Coagulation Box” model: Hgb < 5.5 26

10 10 Kcentra – Nursing Considerations Verbal orders Clarify which “PCC”, what un/kg dose (fIX), indication Contact blood bank or pharmacy to alert of STAT order Administration Concentration, dose and rate vary (~10-20 min) Emergent reversal. Give ASAP (expires 4hrs after mixed) Document lot numbers (blood product) Monitor for allergic reactions and thrombosis (0.9-1.4%) Cost

11 11 References 1.Tanaka KA, Key NS, Levy JH. Blood Coagulation: Hemostatis and Thrombin Regulation. Anesth Analg. 2009;108:1433-46. 2.National Advisory Committee on Blood and Blood Products. Recommendations for use of prothrombin complex concentrates in Canada. Accessed on 11/7/2014. http://www.nacblood.ca/guidelines/PCC-Recommendations-Final-2014-05-16.pdf. 3.Kcentra website: www.Kcentra.com. Maintained by CSL Behring. Accessed on 11/7/14.www.Kcentra.com 4.Lexi-Comp, Inc. (Lexi-Drugs). Lexi-Comp, Inc.;January 29, 2015. 5.Tanaka KA, Szlam F. Treatment of massive bleeding with prothrombin complex concentrate: argument for. J Thromb Haemost. 2010;8:2589-91. 6.Godier A, Susen S, Samama C-M. Tanaka KA, Szlam F. Treatment of massive bleeding with prothrombin complex concentrate: argument against. J Thromb Haemost. 2010;8:2592-95 7.Holbrook A, Schulman S, Witt DM, et al. Evidence-Based Management of Anticoagulant Therapy. Antithrombotic Therapy and Prevention of Thrombosis, 9 th ed: American College of Chest Physicians Evidence-Based Clinical Practice Guidelines. Chest. 2012;141(2)(Suppl):e152S-e184S. 8.Nutescu EA, Dager WE, Kalus JS, Lewin JJ, Cipolle MD. Management of bleeding and reversal strategies for oral anticoagulants: Clinical Practice Considerations. Am J Health-Syst Pharm. 2013;70:1914-1929. 9.Tran H, et al. New oral anticoagulants: a practical guide on prescription, laboratory testing and peri-procedural/ bleeding management. Int Med J. 2014;44:525-536. 10.Dager WE, Gosselin RC, Roberts AJ. Reversing dabigatran in life-threatening bleeding occurring during cardiac ablation with factor eight bypassing activity. Crit Care Med. 2013; 41(1):e42-46. 11.Grottke O, van Ryn J, Sprink HMH, Rossaint R. Prothrombin complex concentrates and a specific antidose to dabigatran are effective ex-vivo in reversing the effects of dabigatran in an anticoagulation/liver trauma experimental model. Crit Care. 2014;18:R27. 12.Dickneite G. Prothrombin Complex Concentrates as Reversal Agents for New Oral Anticoagulants: lessons from preclinical studies with Beriplex. Clin Lab Med. 2014;34:623-635.

12 12 References, cont. 13.Hiippala ST, Mllyla GJ, Vahtera EM. Hemostatic Factors and Replacement of Major Blood Loss with Plasma-Poor Red Cell Concentrates. Anesth Analg. 1995;81:360-5. 14.Rourke C, et al. Fibrinogen levels during trauma hemorrhage, response to replacement therapy, and association with patient outcomes. J Thromb Haemost. 2012;10:1342-51. 15.Sorensen B, Fries D. Emerging treatment strategies for trauma-induced coagulopathy. Brit J Surg. 2 012;99(Suppl1): 40-50. 16.Spahn DR, et al. Management of bleeding and coagulopathy following major trauma: an updated European guideline. Crit Care. 2013;17:R76. 17.Kozek-Langenecker SA, et al. Management of severe perioperative bleeding. Guidelines from the European Society of Anaesthesiology. Eur J Anaesthesiol. 2013;30:270-382. 18.Fries D. The early use of fibrinogen, prothrombin complex concentrate, and recombinant-activated factor VIIa in massive bleeding. Transfusion. 2013;53(s):91s-95s. 19.Tanaka KA, Esper S, Bolliger D. Perioperative factor concentrate therapy. Brit J Anaesth. 2013;111(S1): i35-i49. 20.Schochl H, Grassetto A, Schlimp CJ. Management of Hemorrhage in Trauma. J Cardiothor Vasc Anesth. 2013;27(4): S35-S43. 21.Franchini M, Lippi G. Prothrombin complex concentrates: an update. Blood Transfus. 2010;8:149-54. 22.Joseph B, et al. Factor IX complex for the correction of traumatic coagulopathy. J Trauma. 2010;72(4):828-834. 23.Schick KS, Fertmann JM, Jauch KW, Hoffmann JN. Prothrombin complex concentrates in surgical patients: retrospective evaluation of vitamin K antagonist reversal and treatment of severe bleeding. Crit Care. 2009;13:R191. 24.Carvalho MC, Rodrigues AG, Conceicao LM, Galvao ML, Ribeiro LC. Prothrombin complex concentrate (Octaplex): a Portuguese experience in 1152 patients. Blood Coag Fibrin. 2012;23:222-228. 25.Lorenz R, et al. Efficacy and safety of a prothrombin complex concentrate [Beriplex] with two virus-inactivation steps in patients with severe liver damage. Eur J Gastroenterol Hepatol. 2003;15:15-20. 26.Hilbert P, et al. The “Coagulation Box” and a New Hemoglobin-Driven Algorithm for Bleeding Control in Patients with Severe Multiple Traumas. Arch Trauma Res. 2013;2(1):1-10. 27.Majeed A, Eelde A, Agren A, et al. Thromboembolic safety and efficacy of prothrombin complex concentrates in the emergent reversal of warfarin coagulopathy. Thromb Res. 2012;129:146-51. 28.Innerhofer P, et al. The exclusive use of coagulation factor concentrates enables reversal of coagulopathy and decreases transfusion rates in patients with major blunt trauma. Injury, Int J Care Injured. 2013;44:209-216.


Download ppt "Saving Lives By Strengthening Our Region’s Trauma Care System Management of Trauma Hemorrhage: Possible Role of Kcentra, a 4-factor Prothrombin Complex."

Similar presentations


Ads by Google