Clotting factor product administration and same-day occurrence of thrombotic events, as recorded in a large healthcare database during 2008-2013

Journal of Thrombosis and Haemostasis

Volumn 13, Issue 12, 2015, Pages 2168-2179

  Ekezue, B F ^a   Sridhar, G ^a   Ovanesov, M V ^b   Forshee, R A ^b   Izurieta, H S ^b   Selvam, N ^a   Parunov, L A ^b   Jain, N ^b   Mintz, P D ^b   Epstein, J S ^b   Anderson, S A ^b   Menis, M D ^b  

^a HEALTHCORE INC   (United States)

^b CENTER FOR DRUG EVALUATION AND RESEARCH   (United States)

Author keywords

Clotting factors; Healthcare; Laboratory; Risk factors; Thrombosis

Indexed keywords

BLOOD CLOTTING FACTOR 7A; BLOOD CLOTTING FACTOR 9 COMPLEX; FIBRIN GLUE; RECOMBINANT BLOOD CLOTTING FACTOR 9; BLOOD CLOTTING FACTOR 9; COAGULATING AGENT;

ADULT; AGE; ARTICLE; BLOOD CLOTTING FACTOR DEFICIENCY; COHORT ANALYSIS; CONTROLLED STUDY; FEMALE; HEALTH STATUS; HUMAN; MAJOR CLINICAL STUDY; MALE; MEDICAL HISTORY; MIDDLE AGED; PRIORITY JOURNAL; RETROSPECTIVE STUDY; RISK FACTOR; THROMBOSIS; ADOLESCENT; AGED; CHEMICALLY INDUCED; CHI SQUARE DISTRIBUTION; COMORBIDITY; DRUG ADMINISTRATION; DRUG CONTAMINATION; FACTUAL DATABASE; MULTIVARIATE ANALYSIS; ODDS RATIO; OFF LABEL DRUG USE; RISK ASSESSMENT; STATISTICAL MODEL; TIME FACTOR; UNITED STATES; YOUNG ADULT;

ADOLESCENT; ADULT; AGED; CHI-SQUARE DISTRIBUTION; COAGULANTS; COMORBIDITY; DATABASES, FACTUAL; DRUG ADMINISTRATION SCHEDULE; DRUG CONTAMINATION; FACTOR IX; FEMALE; HUMANS; LOGISTIC MODELS; MALE; MIDDLE AGED; MULTIVARIATE ANALYSIS; ODDS RATIO; OFF-LABEL USE; RETROSPECTIVE STUDIES; RISK ASSESSMENT; RISK FACTORS; THROMBOSIS; TIME FACTORS; UNITED STATES; YOUNG ADULT;

EID: 84958773740     PISSN: 15387933     EISSN: 15387836     Source Type: Journal    
DOI: 10.1111/jth.13155     Document Type: Article

References (50)

1. Key NS, Negrier C. Coagulation factor concentrates: past, present, and future. Lancet 2007; 370: 439-48.
2. Abshire T, Kenet G. Safety update on the use of recombinant factor VIIa and the treatment of congenital and acquired deficiency of factor VIII or IX with inhibitors. Haemophilia 2008; 14: 898-902.
3. Alam A, Cserti-Gazdewich C, Pendergrast J. The off-label utilization of prothrombin complex concentrate with cryoprecipitate as an alternative to plasma transfusion in bleeding patients with acute right ventricular failure. Can J Anaesth 2014; 61: 284-6.
4. 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.
5. Franchini M, Gandini G, Di Paolantonio T, Mariani G. Acquired hemophilia A: a concise review. Am J Hematol 2005; 80: 55-63.
6. Gill R, Herbertson M, Vuylsteke A, Olsen PS, von Heymann C, Mythen M, Sellke F, Booth F, Schmidt TA. Safety and efficacy of recombinant activated factor VII: a randomized placebo-controlled trial in the setting of bleeding after cardiac surgery. Circulation 2009; 120: 21-7.
7. Goodnough LT. A reappraisal of plasma, prothrombin complex concentrates, and recombinant factor VIIa in patient blood management. Crit Care Clin 2012; 28: 413-26, vi-vii.
8. Hsia CC, Zurawska JH, Tong MZ, Eckert K, McAlister VC, Chin-Yee IH. Recombinant activated factor VII in the treatment of non-haemophilia patients: physician under-reporting of thromboembolic adverse events. Transfus Med 2009; 19: 43-9.
9. 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.
10. Lin DM, Murphy LS, Tran MH. Use of prothrombin complex concentrates and fibrinogen concentrates in the perioperative setting: a systematic review. Transfus Med Rev 2013; 27: 91-104.
11. Lusher JM, Arkin S, Abildgaard CF, Schwartz RS. Recombinant factor VIII for the treatment of previously untreated patients with hemophilia A. Safety, efficacy, and development of inhibitors. Kogenate Previously Untreated Patient Study Group. N Engl J Med 1993; 328: 453-9.
12. Mayer SA, Brun NC, Begtrup K, Broderick J, Davis S, Diringer MN, Skolnick BE, Steiner T. Efficacy and safety of recombinant activated factor VII for acute intracerebral hemorrhage. N Engl J Med 2008; 358: 2127-37.
13. Mitra B, Cameron PA, Parr MJ, Phillips L. Recombinant factor VIIa in trauma patients with the 'triad of death'. Injury 2012; 43: 1409-14.
14. O'Connell KA, Wood JJ, Wise RP, Lozier JN, Braun MM. Thromboembolic adverse events after use of recombinant human coagulation factor VIIa. JAMA 2006; 295: 293-8.
15. Rodgers GM. Prothrombin complex concentrates in emergency bleeding disorders. Am J Hematol 2012; 87: 898-902.
16. Zatta A, Mcquilten Z, Kandane-Rathnayake R, Isbister J, Dunkley S, Mcneil J, Cameron P, Phillips L. The Australian and New Zealand Haemostasis Registry: ten years of data on off-licence use of recombinant activated factor VII. Blood Transfus 2015; 13: 86-99.
17. When off label is off target. In: Nature Medicine. Nature Publishing Group, a division of Macmillan Publishers Limited. All Rights Reserved. 2011; pp. 633.
18. Aledort LM. Comparative thrombotic event incidence after infusion of recombinant factor VIIa versus factor VIII inhibitor bypass activity. J Thromb Haemost 2004; 2: 1700-8.
19. Coppola A, Franchini M, Makris M, Santagostino E, Di Minno G, Mannucci PM. Thrombotic adverse events to coagulation factor concentrates for treatment of patients with haemophilia and von Willebrand disease: a systematic review of prospective studies. Haemophilia 2012; 18: e173-87.
20. Kohler M, Heiden M, Harbauer G, Miyashita C, Morsdorf S, Braun B, Ernert P, Wenzel E, Rose S, Pindur G. Comparison of different prothrombin complex concentrates - in vitro and in vivo studies. Thromb Res 1990; 60: 63-70.
21. Levi M, Levy JH, Andersen HF, Truloff D. Safety of recombinant activated factor VII in randomized clinical trials. N Engl J Med 2010; 363: 1791-800.
22. Ruiz-Saez A. Thrombosis in rare bleeding disorders. Hematology 2012; 17(Suppl. 1): S156-8.
23. Schutgens RE, Tuinenburg A, Fischer K, Mauser-Bunschoten EP. Anticoagulation therapy in haemophilia. Managing the unknown. Hamostaseologie 2013; 33: 299-304.
24. Zwiers M, Lefrandt JD, Mulder DJ, Smit AJ, Gans RO, Vliegenthart R, Brands-Nijenhuis AV, Kluin-Nelemans JC, Meijer K. Coronary artery calcification score and carotid intima media thickness in patients with von Willebrand disease. Haemophilia 2013; 19: e186-8.
25. Aledort LM. Factor VIII inhibitor bypassing activity (FEIBA) - addressing safety issues. Haemophilia 2008; 14: 39-43.
26. Auer W, Rottensteiner H, Schrenk H, Hoellriegl W, Schiviz A, Scheiflinger F, Schwarz HP, Turecek PL, Muchitsch EM. Impact of factor IXa content on function, safety and efficacy of recombinant factor IX products. Blood 2012; 120: 2233.
27. ®. Blood 2011; 118: 2266.
28. Dusel CH, Grundmann C, Eich S, Seitz R, Konig H. Identification of prothrombin as a major thrombogenic agent in prothrombin complex concentrates. Blood Coagul Fibrinolysis 2004; 15: 405-11.
29. Goodemand J, Seghatchian MJ. Thrombogenicity of Factor IX concentrates: current state of the art. Clin Lab Hematol 1994; 16: 400-3.
30. Gray E, Tubbs J, Thomas S, Oates A, Boisclair M, Kemball-Cook G, Barrowcliffe TW. Measurement of activated factor IX in factor IX concentrates: correlation with in vivo thrombogenicity. Thromb Haemost 1995; 73: 675-9.
31. Kalina U, Bickhard H, Schulte S. Biochemical comparison of seven commercially available prothrombin complex concentrates. Int J Clin Pract 2008; 62: 1614-22.
32. Kingdon HS, Lundblad RL, Veltkamp JJ, Aronson DL. Potentially thrombogenic materials in factor IX concentrates. Thromb Diath Haemorrh 1975; 33: 617-31.
33. MacGregor I, McLaughlin L, Drummond O, Prowse C, Ferguson J. In vivo models of thrombogenic potential: usefulness and limitations. Acta Haematol 1995; 94(Suppl. 1): 18-23.
34. Sadeghi N, Kahn D, Sayed D, Hoppenstadt D, Jeske W, Harenberg J, Dechristopher P, Fareed J. Compositional differences in commercially available prothrombin complex concentrates. Clin Appl Thromb Hemost 2014; 20: 256-69.
35. Scharrer I. The need for highly purified products to treat hemophilia B. Acta Haematol 1995; 94(Suppl. 1): 2-7.
36. Yu Y, Millar CM. Measurement of factor IX activity in plasma-derived and recombinant concentrates: insights from thrombin generation and activation-based assays. J Thromb Haemost 2014; 12: 62-70.
37. Ramagopalan SV, Wotton CJ, Handel AE, Yeates D, Goldacre MJ. Risk of venous thromboembolism in people admitted to hospital with selected immune-mediated diseases: record-linkage study. BMC Med 2011; 9: 1.
38. Elixhauser A, Steiner C, Harris DR, Coffey RM. Comorbidity measures for use with administrative data. Med Care 1998; 36: 8-27.
39. Quan H, Sundararajan V, Halfon P, Fong A, Burnand B, Luthi JC, Saunders LD, Beck CA, Feasby TE, Ghali WA. Coding algorithms for defining comorbidities in ICD-9-CM and ICD-10 administrative data. Med Care 2005; 43: 1130-9.
40. Artiss [Fibrin Sealant (Human)]. Product Information. http://www.baxter.com/assets/downloads/ARTISS_PI.pdf Baxter Healthcare Corporation, Revised 2011.
41. ™ software for the spatial, temporal, and space-time scan statistics. http://www.satscan.org/ Information Management Services Inc., 2015.
42. van Ryn J, Schurer J, Kink-Eiband M, Clemens A. Reversal of dabigatran-induced bleeding by coagulation factor concentrates in a rat-tail bleeding model and lack of effect on assays of coagulation. Anesthesiology 2014; 120: 1429-40.
43. Bebulin VH (Factor IX Complex). Product Information. http://www.baxalta.com/assets/documents/bebulin_pi.pdf Baxter Healthcare Corporation, 2011.
44. Profilnine SD - factor ix complex. http://www.fda.gov/ucm/groups/fdagov-public/@fdagov-bio-gen/documents/document/ucm261964.pdf Grifols Biologicals Inc., 2013.
45. ® SD. https://www.grifols.com/documents/10192/89417/ft_alphanine_malasia_EN/a1bc830a-346a-474f-8bcc-4faca132c559 Grifols Biologicals Inc., 2013.
46. Ovanesov MV, Panteleev MA, Sinauridze EI, Kireev DA, Plyushch OP, Kopylov KG, Lopatina EG, Saenko EL, Ataullakhanov FI. Mechanisms of action of recombinant activated factor VII in the context of tissue factor concentration and distribution. Blood Coagul Fibrinolysis 2008; 19: 743-55.
47. Nagashima H. Studies on the different modes of action of the anticoagulant protease inhibitors DX-9065a and Argatroban. I. Effects on thrombin generation. J Biol Chem 2002; 277: 50439-44.
48. Hemker HC, Giesen P, AlDieri R, Regnault V, de Smed E, Wagenvoord R, Lecompte T, Beguin S. The calibrated automated thrombogram (CAT): a universal routine test for hyper- and hypocoagulability. Pathophysiol Haemost Thromb 2002; 32: 249-53.
49. Woodle SA, Shibeko AM, Lee TK, Ovanesov MV. Determining the impact of instrument variation and automated software algorithms on the TGT in hemophilia and normalized plasma. Thromb Res 2013; 132: 374-80.
50. Takeyama M, Sakurai Y, Shima M, Matsumoto T, Nogami K, Tanaka I, Takeda T, Giddings JC, Yoshioka A. Heparin-induced inhibitory effects of a prothrombin complex concentrate on global tests of haemostasis. Blood Coagul Fibrinolysis 2007; 18: 1-7.