Safety of fibrinogen concentrate: Analysis of more than 27 years of pharmacovigilance data

Thrombosis and Haemostasis

Volumn 113, Issue 4, 2015, Pages 759-771

  Solomon, Cristina ^a,b   Gröner, Albrecht ^a   Ye, Jian ^c   Pendrak, Inna ^c  

^a CSL BEHRING GMBH   (Germany)

^b PARACELSUS MEDICAL UNIVERSITY   (Austria)

^c CSL BEHRING   (United States)

Author keywords

Fibrinogen; Pharmacovigilance; Safety

Indexed keywords

ACETYLSALICYLIC ACID; ALTEPLASE; AMOXICILLIN PLUS CLAVULANIC ACID; ANESTHETIC AGENT; ANTITHROMBIN III; ANTITHROMBIN III CONCENTRATE; ANTIVIRUS AGENT; APROTININ; BICARBONATE; CEFAZOLIN; CETIRIZINE; DALTEPARIN; DIPEPTIDYL CARBOXYPEPTIDASE INHIBITOR; FIBRINOGEN; FIBRINOGEN CONCENTRATE; FRESH FROZEN PLASMA; HEPARIN; LEPIRUDIN; MAGNESIUM SULFATE; MANNITOL; MYCOPHENOLIC ACID; NADOLOL; NORMOSOL; PROTAMINE SULFATE; PROTHROMBIN COMPLEX; RECOMBINANT BLOOD CLOTTING FACTOR 7A; REMIFENTANIL; SPIRONOLACTONE; TACROLIMUS; UNINDEXED DRUG; HEMOSTATIC AGENT;

ACUTE HEART INFARCTION; AFIBRINOGENEMIA; ANAPHYLAXIS; ARTERY THROMBOSIS; ARTICLE; BLEEDING; BRAIN INFARCTION; CATHETER THROMBOSIS; DEEP VEIN THROMBOSIS; DRUG EFFICACY; DRUG SAFETY; DRUG SURVEILLANCE PROGRAM; FIBRINOGEN DEFECT; GRAFT THROMBOSIS; HEART INFARCTION; HEPATIC ARTERY THROMBOSIS; HUMAN; JUGULAR VEIN THROMBOSIS; KIDNEY ARTERY EMBOLISM; LUNG EMBOLISM; MULTICENTER STUDY (TOPIC); PARESIS; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL (TOPIC); SUPERIOR CAVA VEIN SYNDROME; SYSTEMATIC REVIEW (TOPIC); THROMBOEMBOLISM; THROMBOSIS; THROMBOTIC THROMBOCYTOPENIC PURPURA; THROMBUS; UPPER EXTREMITY DEEP VEIN THROMBOSIS; VEIN THROMBOSIS; VIRUS TRANSMISSION; ADULT; AGED; CHEMICALLY INDUCED; DRUG CONTAMINATION; DRUG HYPERSENSITIVITY; DRUG-RELATED SIDE EFFECTS AND ADVERSE REACTIONS; FEMALE; HEPATITIS B; HEPATITIS C; MALE; MIDDLE AGED; PATIENT SAFETY; RISK ASSESSMENT; RISK FACTOR; TIME; TRANSMISSION; YOUNG ADULT;

ADULT; ADVERSE DRUG REACTION REPORTING SYSTEMS; AGED; DRUG CONTAMINATION; DRUG HYPERSENSITIVITY; DRUG-RELATED SIDE EFFECTS AND ADVERSE REACTIONS; FEMALE; FIBRINOGEN; HEMOSTATICS; HEPATITIS B; HEPATITIS C; HUMANS; MALE; MIDDLE AGED; PATIENT SAFETY; PHARMACOVIGILANCE; RISK ASSESSMENT; RISK FACTORS; THROMBOEMBOLISM; TIME FACTORS; YOUNG ADULT;

EID: 84931274743     PISSN: 03406245     EISSN: None     Source Type: Journal    
DOI: 10.1160/TH14-06-0514     Document Type: Article

References (71)

1. Blome M, Isgro F, Kiessling AH, et al. Relationship between factor XIII activity, fibrinogen, haemostasis screening tests and postoperative bleeding in cardiopulmonary bypass surgery. Thromb Haemost 2005; 93: 1101-1107.
2. Charbit B, Mandelbrot L, Samain E, et al. The decrease of fibrinogen is an early predictor of the severity of postpartum hemorrhage. J Thromb Haemost 2007; 5: 266-273.
3. Karlsson M, Ternstrom L, Hyllner M, et al. Plasma fibrinogen level, bleeding, and transfusion after on-pump coronary artery bypass grafting surgery: a prospective observational study. Transfusion 2008; 48: 2152-2158.
4. Cortet M, Deneux-Tharaux C, Dupont C, et al. Association between fibrinogen level and severity of postpartum haemorrhage: secondary analysis of a prospective trial. Br J Anaesth 2012; 108: 984-989.
5. Gerlach R, Tolle F, Raabe A, et al. Increased risk for postoperative hemorrhage after intracranial surgery in patients with decreased factor XIII activity: implications of a prospective study. Stroke 2002; 33: 1618-1623.
6. Ucar HI, Oc M, Tok M, et al. Preoperative fibrinogen levels as a predictor of postoperative bleeding after open heart surgery. Heart Surg Forum 2007; 10: E392-396.
7. Levy JH, Welsby I, Goodnough LT. Fibrinogen as a therapeutic target for bleeding: a review of critical levels and replacement therapy. Transfusion 2013; 54: 1389-1405.
8. Solomon C, Collis RE, Collins PW. Haemostatic monitoring during postpartum haemorrhage and implications for management. Br J Anaesth 2012; 109: 851-863.
9. Rourke C, Curry N, Khan S, et al. Fibrinogen levels during trauma hemorrhage, response to replacement therapy, and association with patient outcomes. J Thromb Haemost 2012; 10: 1342-1351.
10. Hiippala ST, Myllyla GJ, Vahtera EM. Hemostatic factors and replacement of major blood loss with plasma-poor red cell concentrates. Anesth Analg 1995; 81: 360-365.
11. Erber WN. Massive blood transfusion in the elective surgical setting. Transfus Apher Sci 2002; 27: 83-92.
12. Khan S, Brohi K, Chana M, et al. Hemostatic resuscitation is neither hemostatic nor resuscitative in trauma hemorrhage. J Trauma Acute Care Surg 2014; 76: 561-568.
13. Schochl H, Voelckel W, Maegele M, et al. Trauma-associated hyperfibrinolysis. Hamostaseologie 2012; 32: 22-27.
14. Schochl H, Cadamuro J, Seidl S, et al. Hyperfibrinolysis is common in out-ofhospital cardiac arrest: results from a prospective observational thromboelastometry study. Resuscitation 2013; 84: 454-459.
15. Dirkmann D, Radu-Berlemann J, Gorlinger K, et al. Recombinant tissue-type plasminogen activator-evoked hyperfibrinolysis is enhanced by acidosis and inhibited by hypothermia but still can be blocked by tranexamic acid. J Trauma Acute Care Surg 2013; 74: 482-488.
16. Martini WZ. The effects of hypothermia on fibrinogen metabolism and coagulation function in swine. Metabolism 2007; 56: 214-221.
17. Weinkove R, Rangarajan S. Fibrinogen concentrate for acquired hypofibrinogenaemic states. Transfus Med 2008; 18: 151-157.
18. Hunault-Berger M, Chevallier P, Delain M, et al. Changes in antithrombin and fibrinogen levels during induction chemotherapy with L-asparaginase in adult patients with acute lymphoblastic leukemia or lymphoblastic lymphoma. Use of supportive coagulation therapy and clinical outcome: the CAPELAL study. Haematologica 2008; 93: 1488-1494.
19. CSL Behring. Haemocomplettan P Prescribing Information. 2008.
20. Solomon C, Wendt M. The Factor in the License: In Reference to "Use of Prothrombin Complex Concentrates and Fibrinogen Concentrates in the Perioperative Setting: A Systematic Review". Transfus Med Rev 2013; 28: 31.
21. CSL Behring. RiaSTAP Prescribing Information. 2009.
22. Fenger-Eriksen C, Ingerslev J, Sorensen B. Fibrinogen concentrate--a potential universal hemostatic agent. Expert Opin Biol Ther 2009; 9: 1325-1333.
23. Solomon C, Pichlmaier U, Schoechl H, et al. Recovery of fibrinogen after administration of fibrinogen concentrate to patients with severe bleeding after cardiopulmonary bypass surgery. Br J Anaesth 2010; 104: 555-562.
24. Fenger-Eriksen C, Jensen TM, Kristensen BS, et al. Fibrinogen substitution improves whole blood clot firmness after dilution with hydroxyethyl starch in bleeding patients undergoing radical cystectomy: a randomized, placebo-controlled clinical trial. J Thromb Haemost 2009; 7: 795-802.
25. Fenger-Eriksen C, Lindberg-Larsen M, Christensen AQ, et al. Fibrinogen concentrate substitution therapy in patients with massive haemorrhage and low plasma fibrinogen concentrations. Br J Anaesth 2008; 101: 769-773.
26. Karlsson M, Ternstrom L, Hyllner M, et al. Prophylactic fibrinogen infusion reduces bleeding after coronary artery bypass surgery. A prospective randomised pilot study. Thromb Haemost 2009; 102: 137-144.
27. Rahe-Meyer N, Pichlmaier M, Haverich A, et al. Bleeding management with fibrinogen concentrate targeting a high-normal plasma fibrinogen level: a pilot study. Br J Anaesth 2009; 102: 785-792.
28. Rahe-Meyer N, Solomon C, Winterhalter M, et al. Thromboelastometry-guided administration of fibrinogen concentrate for the treatment of excessive intraoperative bleeding in thoracoabdominal aortic aneurysm surgery. J Thorac Cardiovasc Surg 2009; 138: 694-702.
29. Gorlinger K, Dirkmann D, Hanke AA, et al. First-line therapy with coagulation factor concentrates combined with point-of-care coagulation testing is associated with decreased allogeneic blood transfusion in cardiovascular surgery: a retrospective, single-center cohort study. Anesthesiology 2011; 115: 1179-1191.
30. Rahe-Meyer N, Solomon C, Hanke A, et al. Effects of fibrinogen concentrate as first-line therapy during major aortic replacement surgery: a randomized, placebo-controlled trial. Anesthesiology 2013; 118: 40-50.
31. Weber CF, Gorlinger K, Meininger D, et al. Point-of-care testing: a prospective, randomized clinical trial of efficacy in coagulopathic cardiac surgery patients. Anesthesiology 2012; 117: 531-547.
32. Schochl H, Nienaber U, Hofer G, et al. Goal-directed coagulation management of major trauma patients using thromboelastometry (ROTEM)-guided administration of fibrinogen concentrate and prothrombin complex concentrate. Crit Care 2010; 14: R55.
33. Schochl H, Nienaber U, Maegele M, et al. Transfusion in trauma: thromboelastometry-guided coagulation factor concentrate-based therapy versus standard fresh frozen plasma-based therapy. Crit Care 2011; 15: R83.
34. Bell SF, Rayment R, Collins PW, et al. The use of fibrinogen concentrate to correct hypofibrinogenaemia rapidly during obstetric haemorrhage. Int J Obstet Anesth 2010; 19: 218-223.
35. Warmuth M, Mad P, Wild C. Systematic review of the efficacy and safety of fibrinogen concentrate substitution in adults. Acta Anaesthesiol Scand 2012; 56: 539-548.
36. Kozek-Langenecker S, Sorensen B, Hess JR, et al. Clinical effectiveness of fresh frozen plasma compared with fibrinogen concentrate: a systematic review. Crit Care 2011; 15: R239.
37. Aubron C, Reade MC, Fraser JF, et al. Efficacy and safety of fibrinogen concentrate in trauma patients-a systematic review. J Crit Care 2013; 29: 471. e11-e17.
38. Wikkelso A, Lunde J, Johansen M, et al. Fibrinogen concentrate in bleeding patients. Cochrane Database Syst Rev 2013; 8: CD008864.
39. Kozek-Langenecker SA, Afshari A, Albaladejo P, et al. Management of severe perioperative bleeding: guidelines from the European Society of Anaesthesiology. Eur J Anaesthesiol 2013; 30: 270-382.
40. Solomon C, Hagl C, Rahe-Meyer N. Time course of haemostatic effects of fibrinogen concentrate administration in aortic surgery. Br J Anaesth 2013; 110: 947-956.
41. Dickneite G, Pragst I, Joch C, et al. Animal model and clinical evidence indicating low thrombogenic potential of fibrinogen concentrate (Haemocomplettan P). Blood Coagul Fibrinolysis 2009; 20: 535-540.
42. Martini J, Maisch S, Pilshofer L, et al. Fibrinogen concentrate in dilutional coagulopathy: a dose study in pigs. Transfusion 2014; 54: 149-157.
43. Danes AF, Cuenca LG, Bueno SR, et al. Efficacy and tolerability of human fibrinogen concentrate administration to patients with acquired fibrinogen deficiency and active or in high-risk severe bleeding. Vox Sang 2008; 94: 221-226.
44. Thorarinsdottir HR, Sigurbjornsson FT, Hreinsson K, et al. Effects of fibrinogen concentrate administration during severe hemorrhage. Acta Anaesthesiol Scand 2010; 54: 1077-1082.
45. Ahmed S, Harrity C, Johnson S, et al. The efficacy of fibrinogen concentrate compared with cryoprecipitate in major obstetric haemorrhage--an observational study. Transfus Med 2012; 22: 344-349.
46. Solomon C, Schochl H, Hanke A, et al. Haemostatic therapy in coronary artery bypass graft patients with decreased platelet function: comparison of fibrinogen concentrate with allogeneic blood products. Scand J Clin Lab Invest 2012; 72: 121-128.
47. Bilecen S, Peelen LM, Kalkman CJ, et al. Fibrinogen concentrate therapy in complex cardiac surgery. J Cardiothorac Vasc Anesth 2013; 27: 12-17.
48. Weiss G, Lison S, Glaser M, et al. Observational study of fibrinogen concentrate in massive hemorrhage: evaluation of a multicenter register. Blood Coagul Fibrinolysis 2011; 22: 727-734.
49. Kreuz W, Meili E, Peter-Salonen K, et al. Efficacy and tolerability of a pasteurised human fibrinogen concentrate in patients with congenital fibrinogen deficiency. Transfus Apher Sci 2005; 32: 247-253.
50. Gollop ND, Chilcott J, Benton A, et al. National audit of the use of fibrinogen concentrate to correct hypofibrinogenaemia. Transfus Med 2012; 22: 350-355.
51. Kreuz W, Meili E, Peter-Salonen K, et al. Pharmacokinetic properties of a pasteurised fibrinogen concentrate. Transfus Apher Sci 2005; 32: 239-246.
52. Manco-Johnson MJ, Dimichele D, Castaman G, et al. Pharmacokinetics and safety of fibrinogen concentrate. J Thromb Haemost 2009; 7: 2064-2069.
53. Tanaka KA, Egan K, Szlam F, et al. Transfusion and hematologic variables after fibrinogen or platelet transfusion in valve replacement surgery: preliminary data of purified lyophilized human fibrinogen concentrate versus conventional transfusion. Transfusion 2014; 54: 109-118.
54. Haas T, Fries D, Velik-Salchner C, et al. Fibrinogen in craniosynostosis surgery. Anesth Analg 2008; 106: 725-731.
55. Wafaisade A, Lefering R, Maegele M, et al. Administration of fibrinogen concentrate in exsanguinating trauma patients is associated with improved survival at 6 hours but not at discharge. J Trauma Acute Care Surg 2013; 74: 387-395.
56. Groner A. Reply. Pereira A. Cryoprecipitate versus commercial fibrinogen concentrate in patients who occasionally require a therapeutic supply of fibrinogen: risk comparison in the case of an emerging transfusion-transmitted infection. Haematologica 2007;92:846-9. Haematologica 2008; 93: e24-27.
57. Velthove KJ, Over J, Abbink K, et al. Viral safety of human plasma-derived medicinal products: impact of regulation requirements. Transfus Med Rev 2013; 27: 179-183.
58. Acharya SS, Coughlin A, Dimichele DM, et al. Rare Bleeding Disorder Registry: deficiencies of factors II, V, VII, X, XIII, fibrinogen and dysfibrinogenemias. J Thromb Haemost 2004; 2: 248-256.
59. Mannucci PM, Duga S, Peyvandi F. Recessively inherited coagulation disorders. Blood 2004; 104: 1243-1252.
60. Ni H, Denis CV, Subbarao S, et al. Persistence of platelet thrombus formation in arterioles of mice lacking both von Willebrand factor and fibrinogen. J Clin Invest 2000; 106: 385-392.
61. Remijn JA, Wu YP, Ijsseldijk MJ, et al. Absence of fibrinogen in afibrinogenemia results in large but loosely packed thrombi under flow conditions. Thromb Haemost 2001; 85: 736-742.
62. Drews RE. Critical issues in hematology: anemia, thrombocytopenia, coagulopathy, and blood product transfusions in critically ill patients. Clin Chest Med 2003; 24: 607-622.
63. Narick C, Triulzi DJ, Yazer MH. Transfusion-associated circulatory overload after plasma transfusion. Transfusion 2012; 52: 160-165.
64. O'Shaughnessy DF, Atterbury C, Bolton Maggs P, et al. Guidelines for the use of fresh-frozen plasma, cryoprecipitate and cryosupernatant. Br J Haematol 2004; 126: 11-28.
65. Peyvandi F, Cattaneo M, Inbal A, et al. Rare bleeding disorders. Haemophilia 2008; 14 (Suppl 3): 202-210.
66. Murad MH, Stubbs JR, Gandhi MJ, et al. The effect of plasma transfusion on morbidity and mortality: a systematic review and meta-analysis. Transfusion 2010; 50: 1370-1383.
67. Murphy GJ, Reeves BC, Rogers CA, et al. Increased mortality, postoperative morbidity, and cost after red blood cell transfusion in patients having cardiac surgery. Circulation 2007; 116: 2544-2552.
68. Spiess BD. Platelet transfusions: the science behind safety, risks and appropriate applications. Best Pract Res Clin Anaesthesiol 2010; 24: 65-83.
69. Yang L, Stanworth S, Baglin T. Cryoprecipitate: an outmoded treatment? Transfus Med 2012; 22: 315-320.
70. Gorlinger K, Kozek-Langenecker SA, Spahn DR. Outcome criteria such as massive transfusion are inadequate for matching and result in questionable conclusions. J Trauma Acute Care Surg 2013; 75: 744-745.
71. Jacob D, Marron B, Ehrlich J, et al. Pharmacovigilance as a tool for safety and monitoring: a review of general issues and the specific challenges with end-stage renal failure patients. Drug Healthc Patient Saf 2013; 5: 105-112.