Long-term safety and efficacy of a pasteurized nanofiltrated prothrombin complex concentrate (Beriplex P/N): A pharmacovigilance study

British Journal of Anaesthesia

Volumn 110, Issue 5, 2013, Pages 764-772

  Hanke, A A ^a   Joch, C ^b   Gorlinger K ^c  

^a HANNOVER MEDICAL SCHOOL   (Germany)

^b CSL BEHRING GMBH   (Germany)

^c UNIVERSITY HOSPITAL ESSEN   (Germany)

Author keywords

bleeding; pharmacovigilance; prothrombin; safety; vitamin K antagonist

Indexed keywords

BLOOD CLOTTING FACTOR 10; BLOOD CLOTTING FACTOR 7; BLOOD CLOTTING FACTOR 9; FATTY ACID BINDING PROTEIN; PROTEIN C; PROTEIN S; PROTHROMBIN; PROTHROMBIN COMPLEX; VITAMIN K GROUP; WARFARIN;

ABDOMINAL PAIN; ACUTE APPENDICITIS; ADULT; AGED; ANTICOAGULANT THERAPY; BLOOD CLOTTING DISORDER; CAROTID ATHEROSCLEROSIS; CEREBROVASCULAR ACCIDENT; DIGESTIVE SYSTEM CANCER; DISSEMINATED INTRAVASCULAR CLOTTING; DRUG EFFICACY; DRUG SAFETY; DRUG SURVEILLANCE PROGRAM; ENDOCARDIAL CUSHION DEFECT; FIBULA FRACTURE; GASTROINTESTINAL HEMORRHAGE; HEART ARRHYTHMIA; HEART SURGERY; HEMATURIA; HUMAN; INTESTINE DIVERTICULOSIS; LAPAROSCOPY; LEG AMPUTATION; LEG ISCHEMIA; LONG TERM CARE; MALE; METASTASIS; PELVIS FRACTURE; POSTOPERATIVE HEMORRHAGE; PREOPERATIVE TREATMENT; PRIORITY JOURNAL; PROMYELOCYTIC LEUKEMIA; REVIEW; SEPSIS; THROMBOEMBOLISM; TIBIA FRACTURE; TRAFFIC ACCIDENT; TRISOMY 21;

EID: 84874948973     PISSN: 00070912     EISSN: 14716771     Source Type: Journal    
DOI: 10.1093/bja/aes501     Document Type: Article

References (65)

1. Kessler CM. Urgent reversal of warfarin with prothrombin complex concentrate: where are the evidence-based data? J Thromb Haemost 2006; 4: 963-6.
2. Buller HR, Agnelli G, Hull RD, Hyers TM, Prins MH, Raskob GE. Antithrombotic therapy for venous thromboembolic disease: the Seventh ACCP Conference on Antithrombotic and Thrombolytic Therapy. Chest 2004; 126: 401S-28S
3. Salem DN, Stein PD, Al-Ahmad A, et al. Antithrombotic therapy in valvular heart disease-native and prosthetic: the Seventh ACCP Conference on Antithrombotic and Thrombolytic Therapy. Chest 2004; 126: 457S-82S
4. Singer DE, Albers GW, Dalen JE, Go AS, Halperin JL, Manning WJ. Antithrombotic therapy in atrial fibrillation: the Seventh ACCP Conference on Antithrombotic and Thrombolytic Therapy. Chest 2004; 126: 429S-56S
5. Fareed J, Hoppensteadt DA, Fareed D, et al. Survival of heparins, oral anticoagulants, and aspirin after the year 2010. Semin Thromb Hemost 2008; 34: 58-73
6. Samsa GP, Matchar DB, Goldstein LB, et al. Quality of anticoagulation management among patients with atrial fibrillation: results of a review of medical records from 2 communities. Arch Intern Med 2000; 160: 967-73
7. Levine MN, Raskob G, Beyth RJ, Kearon C, Schulman S. Hemorrhagic complications of anticoagulant treatment: the Seventh ACCP Conference on Antithrombotic and Thrombolytic Therapy. Chest 2004; 126: 287S-310S
8. Hallowell J, Ruigamez A, Johansson S, Wallander M, García- Rodríguez LA. The incidence of bleeding complications associated with warfarin treatment in general practice in the United Kingdom. Br J Gen Pract 2003; 53: 312-14
9. Landefeld CS, Beyth RJ. Anticoagulant-related bleeding: clinical epidemiology, prediction, and prevention. Am J Med 1993; 95: 315-28
10. Fihn SD, McDonell M, Martin D, et al. Risk factors for complications of chronic anticoagulation. A multicenter study. Warfarin Optimized Outpatient Follow-up Study Group. Ann Intern Med 1993; 118: 511-20
11. Flaherty ML, Kissela B, Woo D, et al. The increasing incidence of anticoagulant-associated intracerebral hemorrhage. Neurology 2007; 68: 116-21
12. Palareti G, Leali N, Coccheri S, et al. Bleeding complications of oral anticoagulant treatment: an inception-cohort, prospective collaborative study (ISCOAT). Italian Study on Complications of Oral Anticoagulant Therapy. Lancet 1996; 348: 423-8
13. Fang MC, Go AS, Chang Y, et al. Death and disability from warfarin-associated intracranial and extracranial hemorrhages. Am J Med 2007; 120: 700-5
14. McMahan DA, Smith DM, Carey MA, Zhou XH. Risk of major hemorrhage for outpatients treated with warfarin. J Gen Intern Med 1998; 13: 311-6
15. Hanley JP. Warfarin reversal. J Clin Pathol 2004; 57: 1132-9
16. Kalina U, Bickhard H, Schulte S. Biochemical comparison of seven commercially available prothrombin complex concentrates. Int J Clin Pract 2008; 62: 1614-22
17. Ansell J, Hirsh J, Poller L, Bussey H, Jacobson A, Hylek E. The pharmacology and management of the vitamin K antagonists: the Seventh ACCP Conference on Antithrombotic and Thrombolytic Therapy. Chest 2004; 126: 204S-33S
18. Baglin TP, Keeling DM, Watson HG. Guidelines on oral anticoagulation (warfarin): third edition-2005 update. Br J Haematol 2006; 132: 277-85
19. Rossaint R, Bouillon B, Cerny V, et al. Management of bleeding following major trauma: an updated European guideline. Crit Care 2010; 14: R52
20. Ageno W, Gallus AS, Wittkowsky A, Crowther M, Hylek EM, Palareti G. Oral anticoagulant therapy: Antithrombotic Therapy and Prevention of Thrombosis, 9th ed: American College of Chest Physicians Evidence-Based Clinical Practice Guidelines. Chest 2012; 141: e44S-88S
21. Gorlinger K, Dirkmann D, Hanke AA, et al. First-line therapy with coagulation factor concentrates combined with pointof- care coagulation testing is associated with decreased allogeneic blood transfusion in cardiovascular surgery: a retrospective, single-center cohort study. Anesthesiology 2011; 115: 1179-91
22. 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
23. Schick KS, Fertmann JM, Jauch KW, Hoffmann JN. Prothrombin complex concentrate in surgical patients: retrospective evaluation of vitamin K antagonist reversal and treatment of severe bleeding. Crit Care 2009; 13: R191
24. Bershad EM, Suarez JI. Prothrombin complex concentrates for oral anticoagulant therapy-related intracranial hemorrhage: a review of the literature. Neurocrit Care 2010; 12: 403-13
25. 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
26. 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
27. 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
28. Huttner HB, Schellinger PD, Hartmann M, et al. Hematoma growth and outcome in treated neurocritical care patients with intracerebral hemorrhage related to oral anticoagulant therapy: comparison of acute treatment strategies using vitamin K, fresh frozen plasma, and prothrombin complex concentrates. Stroke 2006; 37: 1465-70
29. Lubetsky A, Hoffman R, Zimlichman R, et al. Efficacy and safety of a prothrombin complex concentrate (Octaplex) for rapid reversal of oral anticoagulation. Thromb Res 2004; 113: 371-8
30. 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
31. Pabinger I, Brenner B, Kalina U, Knaub S, Nagy A, Ostermann H. Prothrombin complex concentrate (Beriplex P/N) for emergency anticoagulation reversal: a prospective multinational clinical trial. J Thromb Haemost 2008; 6: 622-31
32. Pabinger I, Tiede A, Kalina U, Knaub S, Germann R, Ostermann H. Impact of infusion speed on the safety and effectiveness of prothrombin complex concentrate: a prospective clinical trial of emergency anticoagulation reversal. Ann Hematol 2010; 89: 309-16
33. 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
34. Riess HB, Meier-Hellmann A, Motsch J, Elias M, Kursten FW, Dempfle CE. Prothrombin complex concentrate (Octaplex) in patients requiring immediate reversal of oral anticoagulation. Thromb Res 2007; 121: 9-16
35. Vigue B, Ract C, Tremey B, et al. Ultra-rapid management of oral anticoagulant therapy-related surgical intracranial hemorrhage. Intensive Care Med 2007; 33: 721-5
36. Yasaka M, Sakata T, Minematsu K, Naritomi H. Correction of INR by prothrombin complex concentrate and vitamin K in patients with warfarin related hemorrhagic complication. Thromb Res 2003; 108: 25-30
37. Appelboam R, Thomas EO. The headache over warfarin in British neurosurgical intensive care units: a national survey of current practice. Intensive Care Med 2007; 33: 1946-53
38. Kohler M. Thrombogenicity of prothrombin complex concentrates. Thromb Res 1999; 95: S13-7
39. 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
40. Soørensen B, Spahn DR, Innerhofer P, Spannagl M, Rossaint R. Prothrombin complex concentrates: evaluation of safety and thrombogenicity. Crit Care 2011; 15: 201
41. PubMed Advanced Search Builder. Available from www.ncbi.nlm. nih.gov/pubmed/advanced (accessed 30 March 2012)
42. Bagot CN, Cregg R, Patel RK, Shariff A, Arya R. Perioperative myocardial infarction in a patient receiving low-dose prothrombin complex concentrates. Thromb Haemost 2007; 98: 1141-2
43. Pabinger-Fasching I. Warfarin-reversal: results of a phase III study with pasteurised, nanofiltrated prothrombin complex concentrate. Thromb Res 2008; 122 (Suppl. 2): S19-22
44. Sakka S, Sendt W, Hüttemann E. Omentuminfarkt und Portalvenenthrombose im Rahmen der Gabe von PPSB. Intensiv und Notfallbehandlung 2005; 30: 34-7
45. Weiss G, Lison S, Glaser M, et al. Observational study of fibrinogen concentrate in massive hemorrhage: evaluation of a multicenter register. Blood Coagul Fibrinol 2011; 22: 727-34
46. White R, Rushbrook J, McGoldrick J. The dangers of prothrombin complex concentrate administration after heart surgery. Blood Coagul Fibrinol 2008; 19: 609-10
47. Lorenz R, Kienast J, Otto U, et al. Successful emergency reversal of phenprocoumon anticoagulation with prothrombin complex concentrate: a prospective clinical study. Blood Coagul Fibrinol 2007; 18: 565-70
48. 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
49. Hanke AA, Herold U, Dirkmann D, Tsagakis K, Jakob H, Gorlinger K. Thromboelastometry based early goal-directed coagulation management reduces blood transfusion requirements, adverse events, and costs in acute type A aortic dissection: a pilot study. Transfus Med Hemother 2012; 39: 121-8
50. Bruce D, Nokes TJ. Prothrombin complex concentrate (Beriplex P/N) in severe bleeding: experience in a large tertiary hospital. Crit Care 2008; 12: R105
51. Desmettre T, Dubart AE, Capellier G, et al. Emergency reversal of anticoagulation: the real use of prothrombin complex concentrates: a prospective multicenter two year French study from 2006 to 2008. Thromb Res Advance Access published on June 21, 2012, doi: 10.1016/j.thromres.2012.05.029
52. Blonski W, Siropaides T, Reddy KR. Coagulopathy in liver disease. Curr Treat Options Gastroenterol 2007; 10: 464-73
53. Samama CM. Prothrombin complex concentrates: a brief review. Eur J Anaesthesiol 2008; 25: 784-9
54. Dusel CH, Grundmann C, Eich S, Seitz R, Konig H. Identification of prothrombin as a major thrombogenic agent in prothrombin complex concentrates. Blood Coagul Fibrinol 2004; 15: 405-11
55. Makris M, Watson HG. The management of coumarin-induced over-anticoagulation Annotation. Br J Haematol 2001; 114: 271-80
56. Dentali F, Marchesi C, Pierfranceschi MG, et al. Safety of prothrombin complex concentrates for rapid anticoagulation reversal of vitamin K antagonists. A meta-analysis. Thromb Haemost 2011; 106: 429-38
57. Garcia D, Libby E, Crowther MA. The new oral anticoagulants. Blood 2010; 115: 15-20
58. Majeed A, Eelde A, Agren A, Schulman S, Holmstrom M. Thromboembolic safety and efficacy of prothrombin complex concentrates in the emergency reversal of warfarin coagulopathy. Thromb Res 2012; 129: 146-51
59. Weber CF, Görlinger K, Meininger D, et al. Point-of-care testing: a prospective, randomized clinical trial of efficacy in coagulopathic cardiac surgery patients. Anesthesiology 2012; 117: 531-47
60. Trimble SR, Parker CS, Grant AM, Soucie JM, Reyes N. Assessing emerging infectious threats to blood safety for the blood disorders community. Am J Prev Med 2010; 38: S468-74
61. Nowak T, Schafer W, Groener A. Effective pathogen reduction for a plasma-derived prothrombin complex concentrate through multiple dedicated measures. J Thromb Haemost 2007; 5 (Suppl. 2): P-M-100
62. Ostermann H, Haertel S, Knaub S, Kalina U, Jung K, Pabinger I. Pharmacokinetics of Beriplex P/N prothrombin complex concentrate in healthy volunteers. Thromb Haemost 2007; 98: 790-7
63. Schulman S, Bijsterveld NR. Anticoagulants and their reversal. Transfus Med Rev 2007; 21: 37-48
64. Schochl H, Forster L, Woidke R, Solomon C, Voelckel W. Use of rotation thromboelastometry (ROTEM) to achieve successful treatment of polytrauma with fibrinogen concentrate and prothrombin complex concentrate. Anaesthesia 2010; 65: 199-203
65. Schöchl H, Nienaber U, Hofer G, et al. Goal-directed coagulation management of major trauma patients using thromboelastometry (ROTEMw)-guided administration of fibrinogen concentrate and prothrombin complex concentrate. Crit Care 2010; 14: R55