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Evidence Supporting the Use of Recombinant Activated Factor VII in Congenital Bleeding Disorders


microg kg(-1)) recombinant activated factor VII for the treatment and prevention of bleeds in haemophilia A patients with inhibitors: experience from seven European haemophilia centres, Haemophilia, 2009;15:760–5.


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10. Lisman T, Mosnier LO, Lambert T, et al., Inhibition of fibrinolysis by recombinant factor VIIa in plasma from patients with severe hemophilia A, Blood, 2002;99:175–9.


11. Shapiro AD, Gilchrist GS, Hoots WK, et al., Prospective, randomised trial of two doses of rFVIIa (NovoSeven) in haemophilia patients with inhibitors undergoing surgery, Thromb Haemost, 1998;80:773–8.


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15. Konkle BA, Ebbesen LS, Erhardtsen E, et al., Randomized, prospective clinical trial of recombinant factor VIIa for secondary prophylaxis in hemophilia patients with inhibitors, J Thromb Haemost, 2007;5:1904–13.


16. Pruthi RK, Mathew P, Valentino LA, et al., Haemostatic efficacy and safety of bolus and continuous infusion of recombinant factor VIIa are comparable in haemophilia patients with inhibitors undergoing major surgery. Results from an open-label, randomized, multicenter trial, Thromb Haemost, 2007;98:726–32.


17. Young G, Shafer FE, Rojas P, et al., Single 270 microg kg(-1)- dose rFVIIa vs. standard 90 microg kg(-1)-dose rFVIIa and APCC for home treatment of joint bleeds in haemophilia patients with inhibitors: a randomized comparison, Haemophilia, 2008;14:287–94.


18. Obergfell A, Auvinen MK, Mathew P, Recombinant activated factor VII for haemophilia patients with inhibitors undergoing orthopaedic surgery: a review of the literature, Haemophilia, 2008;14:233–41.


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22. Smejkal P, Brabec P, Matyskova M, et al., FEIBA in treatment of acute bleeding episodes in patients with haemophilia A and factor VIII inhibitors: a retrospective survey in regional haemophilia centre, Haemophilia, 2009;15:743–51.


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28. Dimichele D, Negrier C, A retrospective postlicensure survey of FEIBA efficacy and safety, Haemophilia, 2006;12:352–62.


29. Cooper HA, Jones CP, Campion E, et al., Rationale for the use of high dose rFVIIa in a high-titre inhibitor patient with haemophilia B during major orthopaedic procedures, Haemophilia, 2001;7:517–22.


30. Young G, McDaniel M, Nugent DJ, Prophylactic recombinant factor VIIa in haemophilia patients with inhibitors, Haemophilia, 2005;11:203–7.


31. Morfini M, Auerswald G, Kobelt RA, et al., Prophylactic treatment of haemophilia patients with inhibitors: clinical experience with recombinant factor VIIa in European haemophilia centres, Haemophilia, 2007;13:502–7.


32. 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.


33. O’Connell NM, Riddell AF, Pascoe G, et al., Recombinant factor VIIa to prevent surgical bleeding in factor XI deficiency, Haemophilia, 2008;14:775–81.


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35. 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.


36. Franchini M, The use of recombinant activated factor VII in platelet disorders: a critical review of the literature, Blood Transfus, 2009;7:24–8.


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38. Monroe DM, Hoffman M, What does it take to make the perfect clot?, Arterioscler Thromb Vasc Biol, 2006;26:41–8.


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41. Brohi K, Singh J, Heron M, et al., Acute traumatic coagulopathy, J Trauma, 2003;54:1127–30.


42. MacLeod JB, Lynn M, McKenney MG, et al., Early coagulopathy predicts mortality in trauma, J Trauma, 2003;55:39–44.


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Thrombelastography is better than PT, aPTT, and activated clotting time in detecting clinically relevant clotting abnormalities after hypothermia, hemorrhagic shock and resuscitation in pigs, J Trauma, 2008;65:535–43.


44. Plotkin AJ, Wade CE, Jenkins DH, et al., A reduction in clot formation rate and strength assessed by thrombelastography is indicative of transfusion requirements in patients with penetrating injuries, J Trauma, 2008;64:S64–8.


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46. Segal JB, Dzik WH, Paucity of studies to support that abnormal coagulation test results predict bleeding in the setting of invasive procedures: an evidence-based review, Transfusion, 2005;45:1413–25.


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50. Kang YG, Martin DJ, Marquez J, et al., Intraoperative changes in blood coagulation and thrombelastographic monitoring in liver transplantation, Anesth Analg, 1985;64:888–96.


51. McNicol PL, Liu G, Harley ID, et al., Patterns of coagulopathy during liver transplantation: experience with the first 75 cases using thrombelastography, Anaesth Intensive Care, 1994;22:659–65.


52. Spiess BD, Gillies BS, Chandler W, et al., Changes in transfusion therapy and reexploration rate after institution of a blood management program in cardiac surgical patients, J Cardiothorac Vasc Anesth, 1995;9:168–73.


53. Shore-Lesserson L, Manspeizer HE, DePerio M, et al., Thromboelastography-guided transfusion algorithm reduces transfusions in complex cardiac surgery, Anesth Analg, 1999;88:312–9.


54. Manikappa S, Mehta Y, Juneja R, et al., Changes in transfusion therapy guided by thromboelastograph in cardiac surgery, Ann Card Anaesth, 2001;4:21–7.


55. Anderson L, Quasim I, Soutar R, et al., An audit of red cell and blood product use after the institution of thromboelastometry in a cardiac intensive care unit, Transfus Med, 2006;16:31–9.


56. Welsby IJ, Jiao K, Ortel TL, et al., The kaolin-activated Thrombelastograph predicts bleeding after cardiac surgery, J Cardiothorac Vasc Anesth, 2006;20:531–5.


57. Kaufmann CR, Dwyer KM, Crews JD, et al., Usefulness of thrombelastography in assessment of trauma patient coagulation, J Trauma, 1997;42:716–20.


58. Johansson PI, Treatment of massively bleeding patients: introducing real-time monitoring, transfusion packages and thrombelastography (TEGR), ISBT Science Series, 2007;2:159–67.


59. Johansson PI, Bochsen L, Stensballe J, et al., Transfusion packages for massively bleeding patients: The effect on clot formation and stability as evaluated by thrombelastograph (TEG), Transfus Apher Sci, 2008;39:3–8.


60. Johansson PI, Stensballe J, Effect of haemostatic control resuscitation on mortality in massively bleeding patients: a before and after study, Vox Sang, 2009;96:111–8.


61. Johansson PI, Stissing T, Bochsen L, et al., Thrombelastography and tromboelastometry in assessing coagulopathy in trauma, Scand J Trauma Resusc Emerg Med, 2009;17:45.


62. Rivard GE, Brummel-Ziedins KE, Mann KG, et al., Evaluation of the profile of thrombin generation during the process of whole blood clotting as assessed by thrombelastography, J Thromb Haemost, 2005;3:2039–43.


63. Yoshioka A, Nishio K, Shima M, Thrombelastgram as a hemostatic monitor during recombinant factor VIIa treatment in hemophilia A patients with inhibitor to factor VIII, Haemostasis, 1996;26:139–42.


64. Sorensen B, Ingerslev J, Tailoring haemostatic treatment to patient requirements – an update on monitoring haemostatic response using thrombelastography, Haemophilia, 2005;11(Suppl. 1):1–6.


65. Bassus S, Wegert W, Krause M, et al., Platelet-dependent coagulation assays for factor VIII efficacy measurement after substitution therapy in patients with haemophilia A, Platelets, 2006;17:378–84.


66. Trowbridge CC, Stammers AH, Ciccarelli N, et al., Dose titration of recombinant factor VIIa using thromboelastograph monitoring in a child with hemophilia and high titer inhibitors to factor VIII: a case report and brief review, J Extra Corpor Technol, 2006;38:254–9.


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