Over 50 years of fibrinogen concentrate

Clinical and Applied Thrombosis/Hemostasis

Volumn 22, Issue 2, 2016, Pages 109-114

  Costa Filho, Rubens ^a   Hochleitner, Gerald ^b   Wendt, Michael ^c   Teruya, Alexandre ^d   Spahn, Donat R ^e  

^a HOSPITAL PRÓ CARDÍACO   (Brazil)

^b CSL Behring   (Austria)

^c CSL BEHRING GMBH   (Germany)

^d HOSPITAL ISRAELITA ALBERT EINSTEIN   (Brazil)

^e UNIVERSITY HOSPITAL ZURICH   (Switzerland)

Author keywords

bleeding; blood coagulation factors; hemostasis

Indexed keywords

FIBRIN; FIBRINOGEN; FIBRINOGEN CONCENTRATE; FRESH FROZEN PLASMA; THROMBOCYTE CONCENTRATE;

AFIBRINOGENEMIA; BLEEDING; DRUG USE; FIBRINOGEN DEFECT; HUMAN; HYPOFIBRINOGENEMIA; NONHUMAN; PRACTICE GUIDELINE; PRIORITY JOURNAL; REVIEW; HEMORRHAGE; HISTORY;

ANNIVERSARIES AND SPECIAL EVENTS; FIBRINOGEN; HEMORRHAGE; HISTORY, 20TH CENTURY; HISTORY, 21ST CENTURY; HUMANS;

EID: 84957717658     PISSN: 10760296     EISSN: 19382723     Source Type: Journal    
DOI: 10.1177/1076029615601494     Document Type: Review

References (57)

1. Grebe MT, Luu B, Sedding D, et al. Fibrinogen promotes early atherosclerotic changes of the carotid artery in young, healthy adults. J Atheroscler Thromb. 2010; 17 (10): 1003-1008.
2. Reinhart WH,. Fibrinogen-marker or mediator of vascular disease? Vasc Med. 2003; 8 (3): 211-216.
3. Stone MC, Thorp JM,. Plasma fibrinogen-a major coronary risk factor. J R Coll Gen Pract. 1985; 35 (281): 565-569.
4. Douglas S,. Coagulation history, Oxford 1951-53. Br J Haematol. 1999; 107 (1): 22-32.
5. Virchow R,. Faserstoffarten und fibrinogene Substanz. Virchows Archiv. 1847; 1 (3): 572-583.
6. Rosenfeld L,. The fibrinogen to fibrin transformation. In: Origins of Clinical Chemistry: The Evolution of Protein Analysis. New York, NY: Academic Press; 1982: 366.
7. Beck EA,. Historical development of the prothrombin concept. In: Hemker HC, Veltkamp JJ, eds. Prothrombin Related Coagulation Factors. Leiden: Leiden University Press; 1975: 15-24.
8. Spence RK, Erhard J,. History of patient blood management. Best Pract Res Clin Anaesthesiol. 2013; 27 (1): 11-15.
9. Schmidt PJ, Leacock AG,. Forgotten transfusion history: John Leacock of Barbados. BMJ. 2002; 325 (7378): 1485-1487.
10. Giangrande PL,. The history of blood transfusion. Br J Haematol. 2000; 110 (4): 758-767.
11. Puetz J,. Fresh frozen plasma: the most commonly prescribed hemostatic agent. J Thromb Haemost. 2013; 11 (10): 1794-1799.
12. Edsall JT,. Edwin Joseph Cohn (1892-1953). Biogr Mem Natl Acad Sci USA. 1961: 47-84.
13. Hiippala ST, Myllyla GJ, Vahtera EM,. Hemostatic factors and replacement of major blood loss with plasma-poor red cell concentrates. Anesth Analg. 1995; 81 (2): 360-365.
14. Fries D, Martini WZ,. Role of fibrinogen in trauma-induced coagulopathy. Br J Anaesth. 2010; 105 (2): 116-121.
15. Fenger-Eriksen C, Anker-Moller E, Heslop J, Ingerslev J, Sørensen B,. Thrombelastographic whole blood clot formation after ex vivo addition of plasma substitutes: improvements of the induced coagulopathy with fibrinogen concentrate. Br J Anaesth. 2005; 94 (3): 324-329.
16. Martini J, Maisch S, Pilshofer L, Streif W, Martini W, Fries D,. Fibrinogen concentrate in dilutional coagulopathy: a dose study in pigs. Transfusion. 2014; 54 (1): 149-157.
17. Fries D, Krismer A, Klingler A, et al. Effect of fibrinogen on reversal of dilutional coagulopathy: a porcine model. Br J Anaesth. 2005; 95 (2): 172-177.
18. Collins PW, Solomon C, Sutor K, et al. Theoretical modelling of fibrinogen supplementation with therapeutic plasma, cryoprecipitate, or fibrinogen concentrate. Br J Anaesth. 2014; 113 (4): 585-595.
19. Ranucci M, Solomon C,. Supplementation of fibrinogen in acquired bleeding disorders: experience, evidence, guidelines, and licences. Br J Anaesth. 2012; 109 (2): 135-137.
20. Beller FK,. [Blood coagulation disorders as an obstetrical complication]. Dtsch Med Wochenschr. 1957; 82 (23): 913-918.
21. Nitschmann H, Kistler P, Joss A,. Dried fraction I for clinical use from smallest plasma pools, sterile without filtration. Vox Sang. 1957; 2 (2): 100-103.
22. Stampfli K,. [The therapeutic use of fibrinogen (fraction I of Cohn) in fibrinogen deficiency diseases and thrombocytopenias]. Ther Umsch. 1957; 14 (9): 259-263.
23. European Medicines Agency. List of Union reference dates and frequency of submission of periodic safety update reports (PSURs). EMA/630645/2012 Rev.30. Web site. http://www.ema.europa.eu/docs/en-GB/document-library/Other/2012/10/WC500133159.xls. Accessed May 13, 2015.
24. Kozek-Langenecker S, Sorensen B, Hess J, Spahn DR,. Emotional or evidence-based medicine - is there a moral tragedy in haemostatic therapy? Crit Care. 2011; 15 (6): 462.
25. Levy JH, Welsby I, Goodnough LT,. Fibrinogen as a therapeutic target for bleeding: a review of critical levels and replacement therapy. Transfusion. 2014; 54 (5): 1389-1405.
26. 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. 2014; 28 (1): 31.
27. Solomon C, Groner A, Ye J, Pendrak I,. Safety of fibrinogen concentrate: analysis of more than 27 years of pharmacovigilance data. Thromb Haemost. 2015; 113 (4): 759-771.
28. 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 (1): 40-50.
29. Kirchner C, Dirkmann D, Treckmann JW, et al. Coagulation management with factor concentrates in liver transplantation: a single-center experience. Transfusion. 2014; 54 (10 pt 2): 2760-2768.
30. Galas FR, de Almeida JP, Fukushima JT, et al. Hemostatic effects of fibrinogen concentrate compared with cryoprecipitate in children after cardiac surgery: a randomized pilot trial. J Thorac Cardiovasc Surg. 2014; 148 (4): 1647-55.
31. 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 (1): 109-118.
32. 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 (1): 137-144.
33. 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 (3): 531-547.
34. Manco-Johnson MJ, Dimichele D, Castaman G, et al. Pharmacokinetics and safety of fibrinogen concentrate. J Thromb Haemost. 2009; 7 (12): 2064-2069.
35. 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 (3): 247-253.
36. Rahe-Meyer N, Hanke A, Schmidt DS, Hagl C, Pichlmaier M,. Fibrinogen concentrate reduces intraoperative bleeding when used as first-line hemostatic therapy during major aortic replacement surgery: results from a randomized, placebo-controlled trial. J Thorac Cardiovasc Surg. 2013; 145 (3 suppl): S178-S185.
37. 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 (5): 555-562.
38. 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 (2): R55.
39. Noval-Padillo JA, Leon-Justel A, Mellado-Miras P, et al. Introduction of fibrinogen in the treatment of hemostatic disorders during orthotopic liver transplantation: implications in the use of allogenic blood. Transplant Proc. 2010; 42 (8): 2973-2974.
40. Bell SF, Rayment R, Collins PW, Collis RE,. The use of fibrinogen concentrate to correct hypofibrinogenaemia rapidly during obstetric haemorrhage. Int J Obstet Anesth. 2010; 19 (2): 218-223.
41. Sadeghi M, Atefyekta R, Azimaraghi O, et al. A randomized, double blind trial of prophylactic fibrinogen to reduce bleeding in cardiac surgery. Braz J Anesthesiol. 2014; 64 (4): 253-257.
42. Wikkelso AJ, Edwards HM, Afshari A, et al. Pre-emptive treatment with fibrinogen concentrate for postpartum haemorrhage: randomized controlled trial. Br J Anaesth. 2015; 114 (4): 623-633.
43. Ranucci M, Baryshnikova E, Crapelli GB, et al. The Zero-plasma study (ZEPLAST): a randomized, double-blinded, placebo-controlled trial of fibrinogen concentrate supplementation after complex cardiac surgery. J Thorac Cardiovasc Surg. 2015; 4 (6): e002066.
44. Wikkelso A, Lunde J, Johansen M, et al. Fibrinogen concentrate in bleeding patients. Cochrane Database Syst Rev. 2013; 8: Cd008864.
45. Aubron C, Reade MC, Fraser JF, et al. Efficacy and safety of fibrinogen concentrate in trauma patients - a systematic review. J Crit Care. 2014; 29 (3): 471. e411-e477.
46. Lunde J, Stensballe J, Wikkelso A, Johansen M, Afshari A,. Fibrinogen concentrate for bleeding-a systematic review. Acta Anaesthesiol Scand. 2014; 58 (9): 1061-1074.
47. Wikkelso AJ,. The role of fibrinogen and haemostatic assessment in postpartum haemorrhage: preparations for a randomised controlled trial. Dan Med J. 2015; 62 (4): B5055.
48. Ozier Y, Hunt BJ,. Against: Fibrinogen concentrate for management of bleeding: against indiscriminate use. J Thromb Haemost. 2011; 9 (1): 6-8.
49. Stanworth SJ, Hunt BJ,. The desperate need for good-quality clinical trials to evaluate the optimal source and dose of fibrinogen in managing bleeding. Crit Care. 2011; 15 (6): 1006.
50. Ranucci M,. Fibrinogen supplementation in cardiac surgery: where are we now and where are we going? J Cardiothorac Vasc Anesth. 2013; 27 (1): 1-4.
51. ClinicalTrials.gov. Pharmacokinetic, Efficacy, and Safety Study of Octafibrin Compared to Haemocomplettan/Riastap. Web site. http://clinicaltrials.gov/show/NCT01575756. Accessed May 13, 2015.
52. Lord ST, Binnie CG, Hettasch JM, Strickland E,. Purification and characterization of recombinant human fibrinogen. Blood Coagul Fibrinolysis. 1993; 4 (1): 55-59.
53. Radulovic V, Baghaei F, Blixter IF, Samuelsson S, Jeppsson A,. Comparable effect of recombinant and plasma-derived human fibrinogen concentrate on ex vivo clot formation after cardiac surgery. J Thromb Haemost. 2012; 10 (8): 1696-1698.
54. Velik-Salchner C, Haas T, Innerhofer P, et al. The effect of fibrinogen concentrate on thrombocytopenia. J Thromb Haemost. 2007; 5 (5): 1019-1025.
55. Lang T, Johanning K, Metzler H, et al. The effects of fibrinogen levels on thromboelastometric variables in the presence of thrombocytopenia. Anesth Analg. 2009; 108 (3): 751-758.
56. Kaspereit F, Doerr B, Dickneite G,. The effect of fibrinogen concentrate administration on coagulation abnormalities in a rat sepsis model. Blood Coagul Fibrinolysis. 2004; 15 (1): 39-43.
57. Fenger-Eriksen C, Ingerslev J, Sorensen B,. Fibrinogen concentrate - a potential universal hemostatic agent. Expert Opin Biol Ther. 2009; 9 (10): 1325-1333.