Prothrombin complex concentrate for critical bleeding;Concentrado de complejo de protrombina en sangrado crítico

Annals of Pharmacotherapy

Volumn 45, Issue 7-8, 2011, Pages 990-999

  Patanwala, Asad E ^a   Acquisto, Nicole M ^b   Erstad, Brian L ^c  

^a UNIVERSITY OF ARIZONA   (United States)

^b Emergency Medicine Clinical Pharmacy Specialist   (United States)

^c UNIVERSITY OF ROCHESTER MEDICAL CENTER   (United States)

Author keywords

Hemorrhage; Hemostatic agents; Prothrombin complex concentrate

Indexed keywords

ANTIVITAMIN K; FRESH FROZEN PLASMA; PROTHROMBIN COMPLEX; RECOMBINANT BLOOD CLOTTING FACTOR 7A;

ANTICOAGULATION; ARTICLE; BLEEDING; COCHRANE LIBRARY; DISEASE ASSOCIATION; DISEASE SEVERITY; DRUG EFFICACY; DRUG SAFETY; HEMOPHILIA; HUMAN; INTERNATIONAL NORMALIZED RATIO; LIVER FAILURE; MEDICAL LITERATURE; MEDLINE; PRIORITY JOURNAL; THROMBOEMBOLISM; TREATMENT OUTCOME;

BLOOD COAGULATION; BLOOD COAGULATION FACTORS; HEMORRHAGE; HEMOSTATICS; HUMANS; INTERNATIONAL NORMALIZED RATIO; LIVER FAILURE; THROMBOEMBOLISM; WOUNDS AND INJURIES;

EID: 79960789659     PISSN: 10600280     EISSN: None     Source Type: Journal    
DOI: 10.1345/aph.1Q096     Document Type: Article

References (62)

1. Samama CM. Prothrombin complex concentrates: a brief review. Eur J Anaesthesiol 2008;25:784-9.
2. Product information. Profilnine SD (factor IX complex). Los Angeles, CA: Grifols Biologicals Inc., March 2010.
3. Product information. Bebulin VH (factor IX complex). Westlake Village, CA: Baxter Healthcare Corporation, September 2006.
4. Hellstern P, Halbmayer WM, Kohler M, Seitz R, Muller-Berghaus G. Prothrombin complex concentrates: indications, contraindications, and risks: a task force summary. Thromb Res 1999;95:S3-S6.
5. Pinto DJ, Smallheer JM, Cheney DL, Knabb RM, Wexler RR. Factor Xa inhibitors: next-generation antithrombotic agents. J Med Chem 2010;53:6243-74. DOI 10.1021/jm100146h
6. Furie B, Furie BC. Mechanisms of thrombus formation. N Engl J Med 2008;359:938-49. DOI 10.1056/NEJMra0801082
7. Rao LV, Rapaport SI. Activation of factor VII bound to tissue factor: a key early step in the tissue factor pathway of blood coagulation. Proc Natl Acad Sci U S A 1988;85:6687-91. DOI 10.1073/pnas.85.18.6687
8. Hoffman M. Remodeling the blood coagulation cascade. J Thromb Throm-bolysis 2003;16:17-20. DOI 10.1023/B:THRO.0000014588.95061.28
9. Pluta A, Gutkowski K, Hartleb M. Coagulopathy in liver diseases. Adv Med Sci 2010;55:16-21.
10. Tripodi A, Salerno F, Chantarangkul V, et al. Evidence of normal throm-bin generation in cirrhosis despite abnormal conventional coagulation tests. Hepatology 2005;41:553-8. DOI 10.1002/hep.20569
11. Wheeler AP, Rice TW. Coagulopathy in critically ill patients: part 2- soluble clotting factors and hemostatic testing. Chest 2010;137:185-94.
12. Brohi K, Singh J, Heron M, Coats T. Acute traumatic coagulopathy. J Trauma 2003;54:1127-30. DOI 10.1097/01.TA.0000069184.82147.06
13. Midwinter MJ, Woolley T. Resuscitation and coagulation in the severely injured trauma patient. Philos Trans R Soc Lond B Biol Sci 2011;366: 192-203. DOI 10.1098/rstb.2010.0220
14. Ganter MT, Pittet JF. New insights into acute coagulopathy in trauma patients. Best Pract Res Clin Anaesthesiol 2010;24:15-25.DOI 10.1016/j.bpa.2009.09.010
15. Shakur H, Roberts I, Bautista R, et al. Effects of tranexamic acid on death, vascular occlusive events, and blood transfusion in trauma patients with significant haemorrhage (CRASH-2): a randomised, placebo-controlled trial. Lancet 2010;376:23-32.
16. van Aart L, Eijkhout HW, Kamphuis JS et al. Individualized dosing regimen for prothrombin complex concentrate more effective than standard treatment in the reversal of oral anticoagulant therapy: an open, prospective randomized controlled trial. Thromb Res 2006;118:313-20.
17. Ageno W, Garcia D, Aguilar MI, et al. Prevention and treatment of bleeding complications in patients receiving vitamin K antagonists, part 2: treatment. Am J Hematol 2009;84:584-8. DOI 10.1002/ajh.21469
18. Leissinger CA, Blatt PM, Hoots WK, Ewenstein B. Role of prothrombin complex concentrates in reversing warfarin anticoagulation: a review of the literature. Am J Hematol 2008;83:137- 43. DOI 10.1002/ajh.21046
19. Ansell J, Hirsh J, Hylek E, Jacobson A, Crowther M, Palareti G. Pharmacology and management of the vitamin K antagonists: American College of Chest Physicians Evidence-Based Clinical Practice Guidelines (8th Edition). Chest 2008;133:160S-98S. DOI 10.1378/chest.08-0670
20. Product information. Vitamin K1 (phytonadione) injection. Lake Forest, IL: Hospira Inc., August 2006.
21. Levy JH, Tanaka KA, Dietrich W. Perioperative hemostatic management of patients treated with vitamin K antagonists. Anesthesiology 2008;109: 918-26. DOI 10.1097/ALN.0b013e3181895bd8
22. Shander A, Goodnough LT. Update on transfusion medicine. Pharma-cotherapy 2007;27:57S-68S. DOI 10.1592/phco.27.9part2.57S
23. Chowdhury P, Saayman AG, Paulus U, Findlay GP, Collins PW. Efficacy of standard dose and 30 mL/kg fresh frozen plasma in correcting laboratory parameters of haemostasis in critically ill patients. Br J Haematol 2004;125:69-73. DOI 10.1111/j.1365-2141.2004.04868.x
24. Aiyagari V, Testai FD. Correction of coagulopathy in warfarin associated cerebral hemorrhage. Curr Opin Crit Care 2009;15:87-92.DOI 10.1097/MCC.0b013e3283269e4d
25. Product information. Novoseven (coagulation Factor VIIa (recombinant) room temperature stable). Princeton, NJ: Novo Nordisk Inc., August 2010.
26. Taketomi T, Szlam F, Levy JH, Tanaka KA. Warfarin reversal with pro-thrombin complex concentrate confers better antifibrinolytic activity compared with recombinant activated factor VII. Blood Coag Fibrin 2008;19:106-8. DOI 10.1097/MBC.0b013e3282f185c9
27. Dickneite G. Prothrombin complex concentrate versus recombinant factor VIIa for reversal of coumarin anticoagulation. Thrombos Res 2007; 119:643-51. DOI 10.1016/j.thromres.2006.05.011
28. Boulis NM, Bobek MP, Schmaier A, Hoff JT. Use of factor IX complex in warfarin-related intracranial hemorrhage. Neurosurgery 1999;45:1113-8. DOI 10.1097/00006123-199911000-00020
29. Cartmill M, Dolan G, Byrne JL, Byrne PO. Prothrombin complex concentrate for oral anticoagulant reversal in neurosurgical emergencies. Br J Neurosurg 2000;14:458-61.
30. Fredriksson K, Norrving B, Stromblad LG. Emergency reversal of anti-coagulation after intracerebral hemorrhage. Stroke 1992;23:972-7.
31. Holland L, Warkentin TE, Refaai M, Crowther MA, Johnston MA, Saro-de R. Suboptimal effect of a three-factor prothrombin complex concentrate (Profilnine-SD) in correcting supratherapeutic international normalized ratio due to warfarin overdose. Transfusion 2009;49:1171-7.DOI 10.1111/j.1537-2995.2008.02080.x
32. Makris M, Greaves M, Phillips WS, Kitchen S, Rosendaal FR, Preston EF. Emergency oral anticoagulant reversal: the relative efficacy of infusions of fresh frozen plasma and clotting factor concentrate on correction of the coagulopathy. Thromb Haemost 1997;77:477-80.
33. Demeyere R, Gillardin S, Arnout J, Strengers PF. Comparison of fresh frozen plasma and prothrombin complex concentrate for the reversal of oral anticoagulants in patients undergoing cardiopulmonary bypass surgery: a randomized study. Vo x Sang 2010;99:251-60.DOI 10.1111/j.1423-0410.2010.01339.x
34. Crawford JH, Augustson BM. Prothrombinex use for the reversal of warfarin: is fresh frozen plasma needed? Med J Aust 2006;184:365-6.
35. Evans G, Luddington R, Baglin T. Beriplex P/N reverses severe warfarin-induced overanticoagulation immediately and completely in patients presenting with major bleeding. Br J Haematol 2001;115:998-1001. DOI 10.1046/j.1365-2141.2001.03214.x
36. Lubetsky A, Hoffman R, Zimlichman R, et al. Efficacy and safety of a prothrombin complex concentrate (Octaplex) for rapid reversal of oral anticoagulation. Thrombos Res 2004;113:371-8.DOI 10.1016/j.thromres.2004.04.004
37. Preston FE, Laidlaw ST, Sampson B, Kitchen S. Rapid reversal of oral anticoagulation with warfarin by a prothrombin complex concentrate (Beriplex): efficacy and safety in 42 patients. Br J Haematol 2002;116: 619-24. DOI 10.1046/j.0007-1048.2001.03295.x
38. Bruce D, Nokes TJ. Prothrombin complex concentrate (Beriplex P/N) in severe bleeding: experience in a large tertiary hospital. Crit Care (London) 2008;12:R105. DOI 10.1186/cc6987
39. Lankiewicz MW, Hays J, Friedman KD, Tinkoff G, Blatt PM. Urgent reversal of warfarin with prothrombin complex concentrate. J Thromb Haemost 2006;4:967-70. DOI 10.1111/j.1538-7836.2006.01815.x
40. Yasaka M, Sakata T, Naritomi H, Minematsu K. Optimal dose of pro-thrombin complex concentrate for acute reversal of oral anticoagulation. Thrombos Res 2005;115:455-9. DOI 10.1016/j.thromres.2004.09.002
41. Wojcik C, Schymik ML, Cure EG. Activated prothrombin complex concentrate factor VIII inhibitor bypassing activity (FEIBA) for the reversal of warfarin-induced coagulopathy. Int J Emerg Med 2009;2:217-25.
42. Dabbagh O, Oza A, Prakash S, Sunna R, Saettele TM. Coagulopathy does not protect against venous thromboembolism in hospitalized patients with chronic liver disease. Chest 2010;137:1145-9.DOI 10.1378/chest.09-2177
43. Polson J, Lee WM. AASLD position paper: the management of acute liver failure. Hepatology 2005;41:1179-97. DOI 10.1002/hep.20703
44. Shami VM, Caldwell SH, Hespenheide EE, Arseneau KO, Bickston SJ, Macik BG. Recombinant activated factor VII for coagulopathy in fulminant hepatic failure compared with conventional therapy. Liver Transpl 2003;9:138-43. DOI 10.1053/jlts.2003.50017
45. Lorenz R, Kienast J, Otto U, et al. Efficacy and safety of a prothrombin complex concentrate with two virus-inactivation steps in patients with severe liver damage. Eur J Gastroenterol Hepatol 2003;15:15-20.DOI 10.1097/00042737-200301000-00004
46. Schreiber MA. Coagulopathy in the trauma patient. Curr Opin Crit Care 2005;11:590-7. DOI 10.1097/01.ccx.0000186374.49320.ab
47. Malone DL, Hess JR, Fingerhut A. Massive transfusion practices around the globe and a suggestion for a common massive transfusion protocol. J Trauma 2006;60:S91-6. DOI 10.1097/01.ta.0000199549.80731.e6
48. Rossaint R, Bouillon B, Cerny V, et al. Management of bleeding following major trauma: an updated European guideline. Crit Care 2010;14:R52. DOI 10.1186/cc8943
49. Dickneite G, Pragst I. Prothrombin complex concentrate vs fresh frozen plasma for reversal of dilutional coagulopathy in a porcine trauma model. Br J Anaesth 2009;102:345-54. DOI 10.1093/bja/aen391
50. Dickneite G, Dörr B, Kaspereit F, Tanaka KA. Prothrombin complex concentrate versus recombinant factor VIIa for reversal of hemodilution-al coagulopathy in a porcine trauma model. J Trauma Injury Infect Crit Care 2010;68:1151-7. DOI 10.1097/TA.0b013e3181b06364
51. Pragst I, Kaspereit F, Dörr B, Dickneite G. Prothrombin complex concentrate (Beriplex P/N) for control of bleeding after kidney trauma in a rabbit dilutional coagulopathy model. Thrombos Res 2010;125:272-7. DOI 10.1016/j.thromres.2009.10.011
52. Kalina M, Tinkoff G, Gbadebo A, Veneri P, Fulda G. A protocol for the rapid normalization of INR in trauma patients with intracranial hemorrhage on prescribed warfarin therapy. Am Surgeon 2008;74:858-61.
53. Kohler M, Hellstern P, Lechler E, Uberfuhr P, Muller-Berghaus G. Thromboembolic complications associated with the use of prothrombin complex and factor IX concentrates. Thromb Haemost 1998;80:399-402.
54. Surgenor D, Melin M, Steele B, Wheaton L, Penell R. Preparation of barium sulfate eluate of plasma for physiological studies in humans. Vo x Sanguinis 1959;4:71-2.
55. McMillan C, Tullis J, Diamond L. Preliminary clinical trials with barium sulfate eluate. Vo x Sanguinis 1960;5:78-80.
56. Gray E, Tubbs J, Thomas S, et al. Measurement of activated factor IX in factor IX concentrates: correlation with in vivo thrombogenicity. Thromb Haemost 1995;73:675-9.
57. Warren O, Simon B. Massive, fatal, intracardiac thrombosis associated with prothrombin complex concentrate. Ann Emerg Med 2009;53:758-61.DOI 10.1016/j.annemergmed.2008.12.027
58. Spannagl M, Schramm W. Replacement of coagulation factors in liver or multiple organ dysfunction. Thromb Res 1999;95:S51-6.DOI 10.1016/S0049-3848(99)00084-5
59. Kohler M. Thrombogenicity of prothrombin complex concentrates. Thromb Res 1999;95:S13-S17.
60. Baker RI, Coughlin PB, Gallus AS, et al. Warfarin reversal: consensus guidelines, on behalf of the Australasian Society of Thrombosis and Haemostasis. Med J Aust 2004;181:492-7.
61. Baggs J, Patanwala AE, Williams E, Erstad BL. Adequacy of international normalized ratio (INR) reversal after receiving 3-factor prothrom-bin complex concentrate (abstract). Presented at: American College of Clinical Pharmacy Annual Meeting, Austin, TX; 2010 October 20, 2010.
62. Jacques KA, Erstad BL. Availability of information for dosing injectable medications in underweight or obese patients. Am J Health Syst Pharm 2010;67:1948-50.