A systematic review of prothrombin complex concentrate dosing strategies to reverse vitamin K antagonist therapy

Thrombosis Research

Volumn 135, Issue 1, 2015, Pages 9-19

  Khorsand, Nakisa ^a,b   Kooistra, Hilde A M ^a   Van Hest, Reinier M ^c   Veeger, Nic J G M ^a   Meijer, Karina ^a  

^a UNIVERSITY MEDICAL CENTER GRONINGEN   (Netherlands)

^b Central Hospital Pharmacy   (Netherlands)

^c ACADEMIC MEDICAL CENTER   (Netherlands)

Author keywords

Hematology (hemostasis and thrombosis); oral anticoagulants; prothrombin complex concentrates; Vitamin K dependent coagulation proteins

Indexed keywords

ANTIVITAMIN K; BLOOD CLOTTING FACTOR 9 CONCENTRATE; PROTHROMBIN COMPLEX; BLOOD CLOTTING FACTOR; PROTHROMBIN; PROTHROMBIN COMPLEX CONCENTRATES; VITAMIN K GROUP;

BLOOD CLOTTING DISORDER; BODY WEIGHT; DRUG EFFICACY; DRUG SAFETY; EMBASE; HUMAN; INTERNATIONAL NORMALIZED RATIO; MEDLINE; PRIORITY JOURNAL; QUALITY CONTROL; REVIEW; SYSTEMATIC REVIEW; ANTAGONISTS AND INHIBITORS; DRUG ADMINISTRATION; RANDOMIZED CONTROLLED TRIAL (TOPIC); TREATMENT OUTCOME;

BLOOD COAGULATION FACTORS; BODY WEIGHT; DRUG ADMINISTRATION SCHEDULE; HUMANS; INTERNATIONAL NORMALIZED RATIO; PROTHROMBIN; RANDOMIZED CONTROLLED TRIALS AS TOPIC; TREATMENT OUTCOME; VITAMIN K;

EID: 84922468304     PISSN: 00493848     EISSN: 18792472     Source Type: Journal    
DOI: 10.1016/j.thromres.2014.11.019     Document Type: Review

References (46)

1. N.S. Key, and C. Negrier Coagulation factor concentrates: past, present, and future Lancet 370 2007 439 448
2. R. Sarode, T.J. Milling Jr., M.A. Refaai, A. Mangione, A. Schneider, and B.L. Durn Efficacy and safety of a 4-factor prothrombin complex concentrate in patients on vitamin K antagonists presenting with major bleeding: a randomized, plasma-controlled, phase IIIb study Circulation 128 2013 1234 1243
3. D. Keeling, T. Baglin, C. Tait, H. Watson, D. Perry, and C. Baglin British Committee for Standards in Haematology. Guidelines on oral anticoagulation with warfarin - fourth edition Br J Haematol 154 2011 311 324
4. A. Holbrook, S. Schulman, D.M. Witt, P.O. Vandvik, J. Fish, and M.J. Kovacs American College of Chest Physicians. Evidence-based management of anticoagulant therapy: Antithrombotic Therapy and Prevention of Thrombosis, 9th ed: American College of Chest Physicians Evidence-Based Clinical Practice Guidelines Chest 141 2012 e152S e184S
5. G. Pernod, A. Godier, C. Gozalo, B. Tremey, and P. Sie French clinical practice guidelines on the management of patients on vitamin K antagonists in at-risk situations (overdose, risk of bleeding, and active bleeding) Thromb Res 126 2010 e167 e174
6. R.I. Baker, P.B. Coughlin, A.S. Gallus, P.L. Harper, H.H. Salem, and E.M. Wood Warfarin reversal: Consensus guidelines on behalf of the Australasian society of thrombosis and haemostasis Med J Aust 181 2004 492 497
7. A. Majeed, K. Meijer, R. Larrazabal, F. Arnberg, G.J. Luijckx, and R.S. Roberts Mortality in vitamin K antagonist-related intracerebral bleeding treated with plasma or 4-factor prothrombin complex concentrate Thromb Haemost 111 2013
8. F. Dentali, C. Marchesi, M.G. Pierfranceschi, M. Crowther, D. Garcia, and E. Hylek Safety of prothrombin complex concentrates for rapid anticoagulation reversal of vitamin K antagonists. A meta-analysis Thromb Haemost 106 2011 429 438
9. W.E. Dager Using prothrombin complex concentrates to rapidly reverse oral anticoagulant effects Ann Pharmacother 45 2011 1016 1020
10. D. Moher, A. Liberati, J. Tetzlaff, and D.G. Altman PRISMA Group. Preferred reporting items for systematic reviews and meta-analyses: the PRISMA statement Ann Intern Med 151 4 2009 264 269 [W64]
11. D.F. Stroup, J.A. Berlin, S.C. Morton, I. Olkin, G.D. Williamson, and D. Rennie Meta-analysis of observational studies in epidemiology: a proposal for reporting. Meta-analysis Of Observational Studies in Epidemiology (MOOSE) group JAMA 283 2000 2008 2012
12. A. Booth, M. Clarke, D. Ghersi, D. Moher, M. Petticrew, and L. Stewart An international registry of systematic-review protocols Lancet 377 2011 108 109
13. H. Thomas National Collaborating Centre of Methods and Tools: Quality assessment tool for quantitative studies 2008 McMaster University Hamilton (last updated 2010)
14. S.H. Downs, and N. Black The feasibility of creating a checklist for the assessment of the methodological quality both of randomised and non-randomised studies of health care interventions J Epidemiol Community Health 52 1998 377 384
15. J.J. Deeks, J. Dinnes, R. D'Amico, A.J. Sowden, C. Sakarovitch, and F. Song International Stroke Trial Collaborative Group, European Carotid Surgery Trial Collaborative Group. Evaluating non-randomised intervention studies Health Technol Assess 7 2003 1 173 [iii,x]
16. D. Siegal, J. Yudin, S. Kaatz, J.D. Douketis, W. Lim, and A.C. Spyropoulos Periprocedural heparin bridging in patients receiving vitamin K antagonists: systematic review and meta-analysis of bleeding and thromboembolic rates Circulation 126 2012 1630 1639
17. R. Demeyere, S. Gillardin, J. Arnout, and P.F. Strengers Comparison of fresh frozen plasma and prothrombin complex concentrate for the reversal of oral anticoagulants in patients undergoing cardiopulmonary bypass surgery: a randomized study Vox Sang 99 2010 251 260
18. M. Cartmill, G. Dolan, J.L. Byrne, and P.O. Byrne Prothrombin complex concentrate for oral anticoagulant reversal in neurosurgical emergencies Br J Neurosurg 14 2000 458 461
19. T. Kuwashiro, M. Yasaka, R. Itabashi, H. Nakagaki, F. Miyashita, and H. Naritomi Effect of prothrombin complex concentrate on hematoma enlargement and clinical outcome in patients with anticoagulant-associated intracerebral hemorrhage Cerebrovasc Dis 31 2011 170 176
20. M. Yasaka, T. Sakata, K. Minematsu, and H. Naritomi Correction of INR by prothrombin complex concentrate and vitamin K in patients with warfarin related hemorrhagic complication Thromb Res 108 2002 25 30
21. D. Kerebel, L.M. Joly, D. Honnart, J. Schmidt, D. Galanaud, and C. Negrier A French multicenter randomised trial comparing two dose-regimens of Prothrombin Complex Concentrates in urgent anticoagulation reversal Crit Care 17 2013 R4
22. N. Khorsand, N.J. Veeger, R.M. van Hest, P.F. Ypma, J. Heidt, and K. Meijer An observational, prospective, two-cohort comparison of a fixed versus variable dosing strategy of prothrombin complex concentrate to counteract vitamin K antagonists in 240 bleeding emergencies Haematologica 97 2012 1501 1506
23. N. Khorsand, N.J. Veeger, M. Muller, J.W. Overdiek, W. Huisman, and R.M. van Hest Fixed versus variable dose of prothrombin complex concentrate for counteracting vitamin K antagonist therapy Transfus Med 21 2011 116 123
24. L. van Aart, H.W. Eijkhout, J.S. Kamphuis, M. Dam, M.E. Schattenkerk, and T.J. Schouten 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 118 2006 313 320
25. F. Roodheuvel, J.J. Ligtenberg, and J.C. Ter Maaten INR reduction after prothrombin complex concentrate (Co-fact(c)) administration: comparison of INR outcomes in different patient categories at the emergency department Int J Emerg Med 6 2013 14 [1380-6-14]
26. L. Bobbitt, E. Merriman, J. Raynes, R. Henderson, H. Blacklock, and S. Chunilal PROTHROMBINEX((R))-VF (PTX-VF) usage for reversal of coagulopathy: prospective evaluation of thrombogenic risk Thromb Res 128 2011 577 582
27. T. Desmettre, E. Dehours, C.M. Samama, S. Jhundoo, F. Pujeau, and C. Guillaudin Reversal of Vitamin K Antagonist (VKA) effect in patients with severe bleeding: a French multicenter observational study (Optiplex) assessing the use of Prothrombin Complex Concentrate (PCC) in current clinical practice Crit Care 16 2012 R185
28. T. Desmettre, A.E. Dubart, G. Capellier, B. Fanara, M. Puyraveau, and S. Kepka Emergency reversal of anticoagulation: the real use of prothrombin complex concentrates: a prospective multicenter two year French study from 2006 to 2008 Thromb Res 130 2012 e178 e183
29. D. Dowlatshahi, K.S. Butcher, N. Asdaghi, S. Nahirniak, M.L. Bernbaum, and A. Giulivi Poor prognosis in warfarin-associated intracranial hemorrhage despite anticoagulation reversal Stroke 43 2012 1812 1817
30. G. Evans, R. Luddington, and T. Baglin Beriplex P/N reverses severe warfarin-induced overanticoagulation immediately and completely in patients presenting with major bleeding Br J Haematol 115 2001 998 1001
31. M. Fischer, C. Falkensammer, P. Gauss, W. Korp, K. Kubiena, and J. Neubert Administration of a new prothrombin complex concentrate in patients treated with anticoagulants and in patients with liver diseases Med Welt 24 1973 1899 1902
32. S. Haghpanah, M. Karimi, M. Bordbar, R. Kamfiroozi, and H. Asgharzadeh Experience on using prothrombin complex concentrate in urgent warfarin reversal: an Iranian survey Clin Appl Thromb Hemost 19 2013 277 281
33. D. Imberti, A. Magnacavallo, F. Dentali, E. Condoleo, M. Gallerani, and R. Benedetti Emergency reversal of anticoagulation with vitamin K antagonists with 3-factor prothrombin complex concentrates in patients with major bleeding J Thromb Thrombolysis 36 2013 102 108
34. E. Lavenne-Pardonge, M.A. Itegwa, M. Kalaai, G. Klinkenberg, J.L. Loncke, and K. Pelgrims Emergency reversal of oral anticoagulation through PPSB-SD: the fastest procedure in Belgium Acta Anaesthesiol Belg 57 2006 121 125
35. R. Lorenz, J. Kienast, U. Otto, M. Kiehl, D. Schreiter, and S. Haertel Successful emergency reversal of phenprocoumon anticoagulation with prothrombin complex concentrate: a prospective clinical study Blood Coagul Fibrinolysis 18 2007 565 570
36. A. Lubetsky, R. Hoffman, R. Zimlichman, A. Eldor, J. Zvi, and V. Kostenko Efficacy and safety of a prothrombin complex concentrate (Octaplex) for rapid reversal of oral anticoagulation Thromb Res 113 2004 371 378
37. A. Majeed, A. Eelde, A. Agren, S. Schulman, and M. Holmstrom Thromboembolic safety and efficacy of prothrombin complex concentrates in the emergency reversal of warfarin coagulopathy Thromb Res 129 2012 146 151
38. I. Pabinger, B. Brenner, U. Kalina, S. Knaub, A. Nagy, and H. Ostermann Prothrombin complex concentrate (Beriplex(registered trademark) P/N) for emergency anticoagulation reversal: A prospective multinational clinical trial J Thromb Haemost 6 2008 622 631
39. F.E. Preston, S.T. Laidlaw, B. Sampson, and S. Kitchen Rapid reversal of oral anticoagulation with warfarin by a prothrombin complex concentrate (Beriplex): efficacy and safety in 42 patients Br J Haematol 116 2002 619 624
40. H.B. Riess, A. Meier-Hellmann, J. Motsch, M. Elias, F.W. Kursten, and C.E. Dempfle Prothrombin complex concentrate (Octaplex) in patients requiring immediate reversal of oral anticoagulation Thromb Res 121 2007 9 16
41. H. Tran, M. Collecutt, S. Whitehead, and H.H. Salem Prothrombin complex concentrates used alone in urgent reversal of warfarin anticoagulation Intern Med J 41 2011 337 343
42. B. Vigue, C. Ract, B. Tremey, N. Engrand, P.E. Leblanc, and A. Decaux Ultra-rapid management of oral anticoagulant therapy-related surgical intracranial hemorrhage Intensive Care Med 33 2007 721 725
43. M. Yasaka, T. Sakata, H. Naritomi, and K. Minematsu Optimal dose of prothrombin complex concentrate for acute reversal of oral anticoagulation Thromb Res 115 2005 455 459
44. S. Nahirniak, and L. Whitman Recommendations for use of prothrombin Complex Concentrates in Canada. National Advisory Committee on Blood and Blood Products Available at: http://www.nacblood.ca/resources/guidelines/nac-pcc-recommendations-june-2011-final.pdf 2011 [Accessed 06/29, 2011]
45. N. Sadeghi, D. Kahn, J. Cunanan, A. Only, D. Hoppensteadt, and W. Jeske Compositional differences in commercially available prothrombin complex concentrates Blood 120 2012
46. S.A. Voils, and B. Baird Systematic review: 3-factor versus 4-factor prothrombin complex concentrate for warfarin reversal: does it matter? Thromb Res 130 2012 833 840