How I use fibrinogen replacement therapy in acquired bleeding

Blood

Volumn 125, Issue 9, 2015, Pages 1387-1393

  Levy, Jerrold H ^a   Goodnough, Lawrence T ^b  

^a DUKE UNIVERSITY SCHOOL OF MEDICINE   (United States)

^b STANFORD UNIVERSITY SCHOOL OF MEDICINE   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

FIBRINOGEN; FIBRINOGEN CONCENTRATE;

ANIMAL MODEL; BLEEDING; BLOOD CLOTTING; BLOOD CLOTTING DISORDER; BLOOD SUBSTITUTION; CARDIOVASCULAR SURGERY; CLINICAL PRACTICE; CLINICAL TRIAL (TOPIC); CRYOPRECIPITATE; FIBRINOGEN BLOOD LEVEL; HUMAN; INJURY; LICENCE; NONHUMAN; OBSTETRIC HEMORRHAGE; OPERATIVE BLOOD LOSS; ORTHOPEDIC SURGERY; PLASMA TRANSFUSION; POINT OF CARE TESTING; POSTPARTUM HEMORRHAGE; PRIORITY JOURNAL; REVIEW; SYSTEMATIC REVIEW (TOPIC); BLOOD LOSS, SURGICAL; BLOOD TRANSFUSION; CASE REPORT; HEMORRHAGE; MALE; MIDDLE AGED; PROGNOSIS; SURGERY; THORACIC AORTA;

AORTA, THORACIC; BLOOD LOSS, SURGICAL; BLOOD TRANSFUSION; FIBRINOGEN; HEMORRHAGE; HUMANS; MALE; MIDDLE AGED; PHYSICIAN'S PRACTICE PATTERNS; PROGNOSIS;

EID: 84923913745     PISSN: 00064971     EISSN: 15280020     Source Type: Journal    
DOI: 10.1182/blood-2014-08-552000     Document Type: Review

References (100)

1. 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.
2. Fenger-Eriksen C, Lindberg-Larsen M, Christensen AQ, Ingerslev J, Sørensen B. Fibrinogen concentrate substitution therapy in patients with massive haemorrhage and low plasma fibrinogen concentrations. Br J Anaesth. 2008;101(6):769-773.
3. Schöchl H, Cotton B, Inaba K, et al. FIBTEM provides early prediction of massive transfusion in trauma. Crit Care. 2011;15(6):R265.
4. Miller BE, Guzzetta NA, Tosone SR, Levy JH. Rapid evaluation of coagulopathies after cardiopulmonary bypass in children using modified thromboelastography. Anesth Analg. 2000;90(6):1324-1330.
5. Hansen AT, Andreasen BH, Salvig JD, Hvas AM. Changes in fibrin D-dimer, fibrinogen, and protein S during pregnancy. Scand J Clin Lab Invest. 2011;71(2):173-176.
6. 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.
7. Glover NJ, Collis RE, Collins P. Fibrinogen concentrate use during major obstetric haemorrhage. Anaesthesia. 2010;65(12):1229-1230.
8. Velik-Salchner C, Haas T, Innerhofer P, et al. The effect of fibrinogen concentrate on thrombocytopenia. J Thromb Haemost. 2007;5(5):1019-1025.
9. 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.
10. 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.
11. Weisel JW. Fibrinogen and fibrin. Adv Protein Chem. 2005;70:247-299.
12. Martini WZ, Chinkes DL, Pusateri AE, et al. Acute changes in fibrinogen metabolism and coagulation after hemorrhage in pigs. Am J Physiol Endocrinol Metab. 2005;289(5):E930-E934.
13. De Lorenzo C, Calatzis A, Welsch U, Heindl B. Fibrinogen concentrate reverses dilutional coagulopathy induced in vitro by saline but not by hydroxyethyl starch 6%. Anesth Analg. 2006;102(4):1194-1200.
14. Hayakawa M, Sawamura A, Gando S, et al. Disseminated intravascular coagulation at an early phase of trauma is associated with consumption coagulopathy and excessive fibrinolysis both by plasmin and neutrophil elastase. Surgery. 2011;149(2):221-230.
15. Gödje O, Gallmeier U, Schelian M, Grünewald M, Mair H. Coagulation factor XIII reduces postoperative bleeding after coronary surgery with extracorporeal circulation. Thorac Cardiovasc Surg. 2006;54(1):26-33.
16. Gerlach R, Raabe A, Zimmermann M, Siegemund A, Seifert V. Factor XIII deficiency and postoperative hemorrhage after neurosurgical procedures. Surg Neurol. 2000;54(3):260-264, discussion 264-265.
17. Gerlach R, Tölle F, Raabe A, Zimmermann M, Siegemund A, Seifert V. Increased risk for postoperative hemorrhage after intracranial surgery in patients with decreased factor XIII activity: implications of a prospective study. Stroke. 2002;33(6):1618-1623.
18. Nielsen VG, Gurley WQ Jr, Burch TM. The impact of factor XIII on coagulation kinetics and clot strength determined by thrombelastography. Anesth Analg. 2004;99(1):120-123.
19. 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(6):270-382.
20. Spahn DR, Bouillon B, Cerny V, et al. Management of bleeding and coagulopathy following major trauma: an updated European guideline. Crit Care. 2013;17(2):R76.
21. Lowe GD, Rumley A, Woodward M, et al. Epidemiology of coagulation factors, inhibitors and activation markers: the Third Glasgow MONICA Survey. I. Illustrative reference ranges by age, sex and hormone use. Br J Haematol. 1997;97(4):775-784.
22. Fenger-Eriksen C, Ingerslev J, Sørensen B. Fibrinogen concentrate - a potential universal hemostatic agent. Expert Opin Biol Ther. 2009;9(10):1325-1333.
23. 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 Apheresis Sci. 2005;32(3):247-253.
24. 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(5):E392-E396.
25. Charbit B, Mandelbrot L, Samain E, et al PPH Study Group. The decrease of fibrinogen is an early predictor of the severity of postpartum hemorrhage. J Thromb Haemost. 2007;5(2):266-273.
26. Chauleur C, Cochery-Nouvellon E, Mercier E, et al. Some hemostasis variables at the end of the population distributions are risk factors for severe postpartum hemorrhages. J Thromb Haemost. 2008;6(12):2067-2074.
27. Collins PW, Lilley G, Bruynseels D, et al. Fibrin-based clot formation as an early and rapid biomarker for progression of postpartum hemorrhage: a prospective study. Blood. 2014;124(11):1727-1736.
28. Stinger HK, Spinella PC, Perkins JG, et al. The ratio of fibrinogen to red cells transfused affects survival in casualties receiving massive transfusions at an army combat support hospital. J Trauma. 2008;64(2, suppl):S79-S85, discussion S85.
29. Parasnis H, Raje B, Hinduja IN. Relevance of plasma fibrinogen estimation in obstetric complications. J Postgrad Med. 1992;38(4):183-185.
30. 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, quiz 1388.
31. Ciavarella D, Reed RL, Counts RB, et al. Clotting factor levels and the risk of diffuse microvascular bleeding in the massively transfused patient. Br J Haematol. 1987;67(3):365-368.
32. Bolliger D, Szlam F, Molinaro RJ, Rahe-Meyer N, Levy JH, Tanaka KA. Finding the optimal concentration range for fibrinogen replacement after severe haemodilution: an in vitro model. Br J Anaesth. 2009;102(6):793-799.
33. Karkouti K, Callum J, Crowther MA, et al. The relationship between fibrinogen levels after cardiopulmonary bypass and large volume red cell transfusion in cardiac surgery: an observational study. Anesth Analg. 2013;117(1):14-22.
34. 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(6):785-792.
35. Dempfle CE, Kälsch T, Elmas E, et al. Impact of fibrinogen concentration in severely ill patients on mechanical properties of whole blood clots. Blood Coagul Fibrinolysis. 2008;19(8):765-770.
36. Spahn DR, Cerny V, Coats TJ, et al Task Force for Advanced Bleeding Care in Trauma. Management of bleeding following major trauma: a European guideline. Crit Care. 2007;11(1):R17.
37. American Society of Anesthesiologists Task Force on Perioperative Blood Transfusion and Adjuvant Therapies. Practice guidelines for perioperative blood transfusion and adjuvant therapies: an updated report by the American Society of Anesthesiologists Task Force on Perioperative Blood Transfusion and Adjuvant Therapies. Anesthesiology. 2006;105(1):198-208.
38. Fries D, Innerhofer P, Perger P, et al. Coagulation management in trauma-related massive bleeding. - Recommendations of the Task Force for Coagulation (AGPG) of the Austrian Society of Anesthesiology, Resuscitation and Intensive Care Medicine (OGARI) [in German]. Anasthesiol Intensivmed Notfallmed Schmerzther. 2010;45(9):552-561.
39. Bolliger D, Gonsahn M, Levy JH, Williams WH, Tanaka KA. Is preoperative fibrinogen predictive for postoperative bleeding after coronary artery bypass grafting surgery? Transfusion. 2009; 49(9):2006-2007; author reply 2007-2008.
40. 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(3):694-702.
41. Rahe-Meyer N, Sørensen B. For: fibrinogen concentrate for management of bleeding. J Thromb Haemost. 2011;9(1):1-5.
42. Solomon C, Baryshnikova E, Tripodi A, et al. Fibrinogen measurement in cardiac surgery with cardiopulmonary bypass: analysis of repeatability and agreement of Clauss method within and between six different laboratories. Thromb Haemost. 2014;112(1):109-117.
43. Molinaro RJ, Szlam F, Levy JH, Fantz CR, Tanaka KA. Low plasma fibrinogen levels with the Clauss method during anticoagulation with bivalirudin. Anesthesiology. 2008;109(1):160-161.
44. Fenger-Eriksen C, Moore GW, Rangarajan S, Ingerslev J, Sørensen B. Fibrinogen estimates are influenced by methods of measurement and hemodilution with colloid plasma expanders. Transfusion. 2010;50(12):2571-2576.
45. Solomon C, Cadamuro J, Ziegler B, et al. A comparison of fibrinogen measurement methods with fibrin clot elasticity assessed by thromboelastometry, before and after administration of fibrinogen concentrate in cardiac surgery patients. Transfusion. 2011;51(8):1695-1706.
46. Goodnough LT, Levy JH, Murphy MF. Concepts of blood transfusion in adults. Lancet. 2013; 381(9880):1845-1854.
47. Yang L, Stanworth S, Hopewell S, Doree C, Murphy M. Is fresh-frozen plasma clinically effective? An update of a systematic review of randomized controlled trials. Transfusion. 2012; 52(8):1673-1686, quiz 1673.
48. Stanworth SJ, Brunskill SJ, Hyde CJ, McClelland DB, Murphy MF. Is fresh frozen plasma clinically effective? A systematic review of randomized controlled trials. Br J Haematol. 2004;126(1):139-152.
49. 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(6):1370-1383.
50. Inaba K, Branco BC, Rhee P, et al. Impact of plasma transfusion in trauma patients who do not require massive transfusion. J Am Coll Surg. 2010;210(6):957-965.
51. Nascimento B, Callum J, Tien H, et al. Effect of a fixed-ratio (1:1:1) transfusion protocol versus laboratory-results-guided transfusion in patients with severe trauma: a randomized feasibility trial. CMAJ. 2013;185(12):E583-E589.
52. Chowdary P, Saayman AG, Paulus U, Findlay GP, Collins PW. Efficacy of standard dose and 30 ml/kg fresh frozen plasma in correcting laboratory parameters of haemostasis in critically ill patients [published correction appears in Br J Haematol. 2012;156(2):292]. Br J Haematol. 2004;125(1):69-73.
53. Kozek-Langenecker S, Sørensen B, Hess JR, Spahn DR. Clinical effectiveness of fresh frozen plasma compared with fibrinogen concentrate: a systematic review. Crit Care. 2011;15(5):R239.
54. Kasper CK. Judith Graham Pool and the discovery of cryoprecipitate. Haemophilia. 2012; 18(6):833-835.
55. Callum JL, Karkouti K, Lin Y. Cryoprecipitate: the current state of knowledge. Transfus Med Rev. 2009;23(3):177-188.
56. Lee SH, Lee SM, Kim CS, et al. Fibrinogen recovery and changes in fibrin-based clot firmness after cryoprecipitate administration in patients undergoing aortic surgery involving deep hypothermic circulatory arrest. Transfusion. 2014;54(5):1379-1387.
57. Stanworth SJ. The evidence-based use of FFP and cryoprecipitate for abnormalities of coagulation tests and clinical coagulopathy. Hematology (Am Soc Hematol Educ Program). 2007;2007(1):179-186.
58. Nascimento B, Goodnough LT, Levy JH. Cryoprecipitate therapy. Br J Anaesth. 2014; 113(6):922-934.
59. O'Shaughnessy DF, Atterbury C, Bolton Maggs P, et al; British Committee for Standards in Haematology, Blood Transfusion Task Force. Guidelines for the use of fresh-frozen plasma, cryoprecipitate and cryosupernatant. Br J Haematol. 2004;126(1):11-28.
60. Gröner 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(2):e24-e26; author reply e27.
61. Franchini M, Lippi G. Fibrinogen replacement therapy: a critical review of the literature. Blood Transfus. 2012;10(1):23-27.
62. Schöchl 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(2):199-203.
63. Schöchl 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.
64. 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.
65. Lang T, Bauters A, Braun SL, et al. Multi-centre investigation on reference ranges for ROTEM thromboelastometry. Blood Coagul Fibrinolysis. 2005;16(4):301-310.
66. Weber CF, Zacharowski K, Meybohm P, et al. Hemotherapy algorithms for coagulopathic cardiac surgery patients. Clin Lab. 2014;60(6): 1059-1063.
67. 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.
68. Solomon C, Hagl C, Rahe-Meyer N. Time course of haemostatic effects of fibrinogen concentrate administration in aortic surgery. Br J Anaesth. 2013;110(6):947-956.
69. Schlimp CJ, Voelckel W, Inaba K, Maegele M, Ponschab M, Schöchl H. Estimation of plasma fibrinogen levels based on hemoglobin, base excess and Injury Severity Score upon emergency room admission. Crit Care. 2013; 17(4):R137.
70. Brenni M, Worn M, Brüesch M, Spahn DR, Ganter MT. Successful rotational thromboelastometry-guided treatment of traumatic haemorrhage, hyperfibrinolysis and coagulopathy. Acta Anaesthesiol Scand. 2010; 54(1):111-117.
71. Schöchl 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(2):R83.
72. Innerhofer P, Westermann I, Tauber H, et al. The exclusive use of coagulation factor concentrates enables reversal of coagulopathy and decreases transfusion rates in patients with major blunt trauma. Injury. 2013;44(2):209-216.
73. Wafaisade A, Lefering R, Maegele M, et al Trauma Registry of DGU. 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(2):387-3, discussion 393-395.
74. Schöchl H, Maegele M, Solomon C, Görlinger K, Voelckel W. Early and individualized goaldirected therapy for trauma-induced coagulopathy. Scand J Trauma Resusc Emerg Med. 2012;20:15.
75. Nuttall GA, Oliver WC, Santrach PJ, et al. Efficacy of a simple intraoperative transfusion algorithm for nonerythrocyte component utilization after cardiopulmonary bypass. Anesthesiology. 2001; 94(5):773-781; discussion 5A-6A.
76. Sniecinski RM, Levy JH. Bleeding and management of coagulopathy. J Thorac Cardiovasc Surg. 2011;142(3):662-667.
77. Karlsson M, Ternström L, Hyllner M, Baghaei F, Nilsson S, Jeppsson A. Plasma fibrinogen level, bleeding, and transfusion after on-pump coronary artery bypass grafting surgery: a prospective observational study. Transfusion. 2008;48(10):2152-2158.
78. Kindo M, Hoang Minh T, Gerelli S, et al. Plasma fibrinogen level on admission to the intensive care unit is a powerful predictor of postoperative bleeding after cardiac surgery with cardiopulmonary bypass. Thromb Res. 2014; 134(2):360-368.
79. Karlsson M, Ternström 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.
80. Solomon C, Schöchl 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(2):121-128.
81. Hazra S, Chilaka VN, Rajendran S, Konje JC. Massive postpartum haemorrhage as a cause of maternal morbidity in a large tertiary hospital. J Obstet Gynaecol. 2004;24(5):519-520.
82. Zhang WH, Alexander S, Bouvier-Colle MH, Macfarlane A; MOMS-B Group. Incidence of severe pre-eclampsia, postpartum haemorrhage and sepsis as a surrogate marker for severe maternal morbidity in a European population-based study: the MOMS-B survey. BJOG. 2005;112(1):89-96.
83. Abdul-Kadir R, McLintock C, Ducloy AS, et al. Evaluation and management of postpartum hemorrhage: consensus from an international expert panel. Transfusion. 2014;54(7): 1756-1768.
84. 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(6):984-989.
85. Gayat E, Resche-Rigon M, Morel O, et al. Predictive factors of advanced interventional procedures in a multicentre severe postpartum haemorrhage study. Intensive Care Med. 2011; 37(11):1816-1825.
86. de Lloyd L, Bovington R, Kaye A, et al. Standard haemostatic tests following major obstetric haemorrhage. Int J Obstet Anesth. 2011;20(2): 135-141.
87. Wikkelsoe AJ, Afshari A, Stensballe J, et al. The FIB-PPH trial: fibrinogen concentrate as initial treatment for postpartum haemorrhage: study protocol for a randomised controlled trial. Trials. 2012;13:110.
88. Innerhofer P, Fries D, Margreiter J, et al. The effects of perioperatively administered colloids and crystalloids on primary platelet-mediated hemostasis and clot formation. Anesth Analg. 2002;95(4):858-865.
89. Mittermayr M, Streif W, Haas T, et al. Hemostatic changes after crystalloid or colloid fluid administration during major orthopedic surgery: the role of fibrinogen administration. Anesth Analg. 2007;105(4):905-917.
90. Haas T, Fries D, Velik-Salchner C, Oswald E, Innerhofer P. Fibrinogen in craniosynostosis surgery. Anesth Analg. 2008;106(3):725-731.
91. Haas T, Goobie S, Spielmann N, Weiss M, Schmugge M. Improvements in patient blood management for pediatric craniosynostosis surgery using a ROTEM(®)-assisted strategy - feasibility and costs. Paediatr Anaesth. 2014; 24(7):774-780.
92. Chambers LA, Chow SJ, Shaffer LE. Frequency and characteristics of coagulopathy in trauma patients treated with a low- or high-plasma-content massive transfusion protocol. Am J Clin Pathol. 2011;136(3):364-370.
93. Levy JH, Dutton RP, Hemphill JC III, et al Hemostasis Summit Participants. Multidisciplinary approach to the challenge of hemostasis. Anesth Analg. 2010;110(2):354-364.
94. Tanaka KA, Taketomi T, Szlam F, Calatzis A, Levy JH. Improved clot formation by combined administration of activated factor VII (NovoSeven) and fibrinogen (Haemocomplettan P). Anesth Analg. 2008;106(3):732-738.
95. Goodnough LT, Shander A. Patient blood management. Anesthesiology. 2012;116(6): 1367-1376.
96. The CRASH-2 collaborators. The importance of early treatment with tranexamic acid in bleeding trauma patients: an exploratory analysis of the CRASH-2 randomised controlled trial. Lancet. 2011;377(9771):1096-1101, 1011.e1-1101.e2.
97. CRASH-2 trial collaborators. Effects of tranexamic acid on death, vascular occlusive events, and blood transfusion in trauma patients with significant haemorrhage (CRASH-2): a randomised, placebo-controlled trial. Lancet. 2010;376(9734):23-32.
98. Ducloy-Bouthors AS, Jude B, Duhamel A, et al EXADELI Study Group. High-dose tranexamic acid reduces blood loss in postpartum haemorrhage. Crit Care. 2011;15(2):R117.
99. Levy JH. Antifibrinolytic therapy: new data and new concepts. Lancet. 2010;376(9734):3-4.
100. Görlinger K. Coagulation management during liver transplantation [in German]. Hamostaseologie. 2006;26(3, suppl 1):S64-S76.