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Drug Evaluation

The emerging role of recombinant activated Factor VII (rFVIIa) in the treatment of blunt traumatic haemorrhage

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Pages 73-81 | Published online: 22 Dec 2005

Bibliography

  • HEDNER U, KISIEL W: Use of human Factor VIIa in the treatment of two hemophilia A patients with high-titer inhibitors. J. Clin. Invest. (1983) 71(6):1836-1841.
  • HEDNER U, BJOERN S, BERNVIL SS, TENGBORN L, STIGENDAHL L: Clinical experience with human plasma-derived Factor VIIa in patients with hemophilia A and high titer inhibitors. Haemostasis (1989) 19(6):335-343.
  • JURLANDER B, THIM L, KLAUSEN NK et al.: Recombinant activated Factor VII (rFVIIa): characterization, manufacturing, and clinical development. Semin. Thromb. Hemost. (2001) 27(4):373-384.
  • HOFFMAN M, MONROE DM: A cell-based model of haemostasis. Thromb. Haemost. (2001) 85:958-965.
  • HOFFMAN M: A cell-based model of coagulation and the role of Factor VIIa. Blood Rev. (2003) 17(1):S1-S5.
  • HOFFMAN M, MONROE DM, ROBERTS HR: Activated Factor VII activates Factors IX and X on the surface of activated platelets: thoughts on the mechanism of action of high-dose activated Factor VII. Blood Coagul. Fibrinolysis (1998) 9(1):S61-S65.
  • MONROE DM, HOFFMAN M, OLIVER JA et al.: Platelet activity of high-dose Factor VIIa is independent of tissue factor. Br. J. Haematol. (1997) 99:542-547.
  • MONROE DM, HOFFMAN M, OLIVER JA et al.: A possible mechanism of action of activated Factor VII independent of tissue factor. Blood Coagul. Fibrinolysis (1998) 9(1):S15-S20.
  • ERHARDTSEN E: Pharmacokinetics of recombinant activated Factor VII. Semin Thromb. Haemost. (2000) 26:385-391.
  • FRIDBERG, MJ, HEDNER U, ROBERTS HR, ERHARDSTEN E: A study of the pharmacokinetics and safety of recombinant activated Factor VII in healthy Caucasian and Japanese subjects. Blood Coagul. Fibrinolysis (2005) 16(4):259-266.
  • HEDNER U, KRISTENSEN H, BERNTORP E et al.: Pharmacokinetics of rFVIIa in children. Haemophilia (1998) 4:355 (Abstract).
  • VILLAR A, ARONIS S, MORFINI M et al.: Pharmacokinetics of activated recombinant coagulation Factor VII (NovoSeven) in children versus adults with haemophilia A. Haemophilia (2004) 10(4):352-359.
  • ROBERTS HR: Recombinant Factor VIIa: how safe is the stuff? Can. J. Anesth. (2005) 52(1):8-11.
  • ABSHIRE T, KENET G: Recombinant Factor VIIa: a review of efficacy, dosing regimens and safety in patients with congenital and acquired Factor VII or IX inhibitors. J. Thromb. Haemost. (2004) 2:899-909.
  • LEVI M, PETERS M, BULLER HR: Efficacy and safety of recombinant Factor VIIa for treatment of severe bleeding: a systematic review. Crit. Care Med. (2005) 33:883-890.
  • PARAMESWARAN R, SHAPIRO AD, GILL JC et al.: Dose effect and efficacy of rFVIIa in the treatment of haemophilia patients with inhibitors: analysis from the Hemophilia and Thrombosis Research Society Registry. Haemophilia (2005) 11:100-106.
  • MAYER SA, BRUN NC, BEGTRUP K et al.: Recombinant activated Factor VII for acute intracerebral hemorrhage. N. Engl. J. Med. (2005) 352:777-785.
  • MAYER SA, BRUN NC, BRODERICK J et al.: Safety and feasibility of recombinant Factor VIIa for acute intracerebral hemorrhage. Stroke (2005) 36:74-79.
  • MAYER SA, BRUN N, BRODERICK J et al.: Safety and preliminary efficacy of recombinant coagulation Factor VIIa in acute intracerebral hemorrhage: US Phase IIA Study. Stroke (2004) 35:332.
  • MAYER SA, BRUN NC: N. Engl. J. Med. (2005) 352(20):2133-2134; author reply 2134.
  • MARTINOWITZ U, MICHAELSON M: The Israeli Multidisciplinary rFVIIa Task Force. Guidelines for the use of recombinant activated Factor VIIa in uncontrolled bleeding: a report by the Israeli Multidisciplinary rFVIIa Task Force. J. Thromb. Haemost. (2005) 3:640-648.
  • KEY NS, ALEDORT LM, BEARDSLEY D et al.: Home treatment of mild to moderate bleeding episodes using recombinant Factor VIIa (NovoSeven®) in haemophiliacs with inhibitors. Thromb. Haemost. (1998) 80:912-918.
  • SHAPIRO AD, GILCHRIST GS, HOOTS WK, COOPER HA, GASTINEAU DA: Prospective, randomised trial of two doses of rFVIIa (NovoSeven®) in haemophilia patients with inhibitors undergoing surgery. Thromb. Haemost. (1998) 80:773-778.
  • LUSHER JM, ROBERTS HR, DAVIGNON G et al.: A randomized, double-blind comparison of two dosage levels of recombinant Factor VIIa in the treatment of joint, muscle and mucocutaneous haemorrhages in persons with haemophilia A and B, with and without inhibitors. rFVIIa Study Group. Haemophilia (1998) 4:790-798.
  • INGERSLEV J, FREIDMAN D, GASTINEAU D et al.: Major surgery in haemophilic patients with inhibitors using recombinant Factor VIIa. Haemostasis (1996) 26(1):118-123.
  • MCPHERSON J, TEAGUE L, LLOYD J et al.: Experience with recombinant Factor VIIa in Australia and New Zealand. Haemostasis (1996) 26(1):109-117.
  • ARKIN S, COOPER HA, HUTTER JJ et al.: Activated recombinant human coagulation Factor VII therapy for intracranial hemorrhage in patients with hemophilia A or B with inhibitors. Results of the NovoSeven® emergency-use program. Haemostasis (1998) 28:93-98.
  • LIEBMAN HA, CHEDIAK J, FINK KI, GALVEZ AG, SHAH PC, SHAH RL: Activated recombinant human coagulation Factor VII (rFVIIa) therapy for abdominal bleeding in patients with inhibitory antibodies to Factor VIII. Am. J. Hematol. (2000) 63:109-113.
  • SCHARRER I: Recombinant Factor VIIa for patients with inhibitors to Factor VIII or IX or Factor VII deficiency. Haemophilia (1999) 5:253-259.
  • MARIANI G, TESTA MG, DI PAOLANTONIO T et al.: Use of recombinant, activated Factor Vii in the treatment of congenital Factor VII deficiencies. Vox Sang. (1999) 77:131-136.
  • INGERSLEV J, KNUDSEN L, HVID I, TANGE MR, FREDBERG U, SNEPPEN O: Use of recombinant Factor VIIa in surgery in factor-VII-deficient patients. Haemophilia (1997) 3:215-218.
  • POON MC, DEMERS C, JOBIN F et al.: Recombinant Factor VIIa is effective for bleeding and surgery in patients with Glanzmann thrombasthenia. Blood (1999) 94:3951-3953.
  • TENGBORN L, PETRUSON B: A patient with Glanzmann thrombasthenia and epistaxis successfully treated with recombinant Factor VIIa. Thromb. Haemost. (1996) 75:981-982.
  • POON MC, KATSAROU O, HUTH-KUEHNE A: Recombinant Factor VIIa in congenital platelet bleeding disorders. Blood (2000) 96:256a.
  • D’OIRON R, MENART C, TRZECIAK MC et al.: Use of recombinant Factor VIIa in 3 patients with inherited Type I Glanzmann’s thrombasthenia undergoing invasive procedures. Thromb. Haemost. (2000) 83:644-647.
  • JANSON TL, STORMORKEN H, PRYDZ H: Species specificity of tissue thromboplastin. Hemostasis (1984) 14:440-444.
  • KASE F: The effect of homo- and heterologous thromboplastins on plasmas of man, seven mammalian and two avian species: a comparative study. Comp. Biochem. Physiol. (1978) 61A:65-68.
  • MARTINOWITZ U, HOLCOMB JB, PUSATERI AE et al.: Intravenous rFVIIa administered for hemorrhage control in hypothermic coagulopathic swine with grade V liver injuries. J. Trauma (2001) 50:721-729.
  • JEROUKHIMOV I, JEWELEWICZ D, ZAIAS J et al.: Early injection of high-dose recombinant Factor VIIa decreases blood loss and prolongs time from injury to death in experimental liver injury. J. Trauma (2002) 53(6):1053-1057.
  • MOORE EE, COGBILL TH, JURKOVICH GJ et al.: Organ injury scaling: spleen and liver (1994 revision). J. Trauma (1995) 38:323-324.
  • SCHREIBER MA, HOLCOMB JB, HEDNER U, BRUNDAGE SI, MACAITIS JM, HOOTS K: The effect of recombinant Factor VIIa on coagulopathic pigs with grade V liver injuries. J. Trauma (2002) 53:252-259.
  • SCHREIBER MA, HOLCOMB JB, HEDNER U et al.: The effect of recombinant factor VIIa on noncoagulopathic pigs with Grade V liver injuries. J. Am. Coll. Surg. (2003) 196:691-697.
  • ODEYEMI IA, GUEST JF: Modelling the economic impact of recombinant activated Factor VII and activated prothrombin concentrate in adults with inhibitors to clotting factors VIII and IX at a comprehensive care centre in the UK. J. Med. Econ. (2002) 5:51-64.
  • ODEYEMI IA, GUEST JF: Modelling the economic impact of recombinant activated Factor VII compared to activated prothrombin concentrate in the home treatment of adults with inhibitors to clotting factors VIII and IX in the UK. J. Med. Econ. (2002) 5:119-133.
  • KNIGHT C, PAISLEY S, WIGHT J, JONES ML: Economic modelling of different treatment strategies for haemophilia A with high-responding inhibitors. Haemophilia (2003) 9(4):521-540.
  • HENDRIKS H, MEIJER K, DE WOOLF J et al.: Reduced transfusion requirements by recombinant Factor VIIa in orthotopic liver transplantation. A pilot study. Transplantation (2001) 71:402-405.
  • PLANINSIC RM, VAN DER MEER J, TESTA G et al.: Safety and efficacy of a single bolus administration of recombinant Factor VIIa in liver transplantation due to chronic liver disease. Liver Transpl. (2005) 11:895-900.
  • LODGE JP, JONAS S, JONES RM et al.: Efficacy and safety of repeated perioperative doses of recombinant Factor VIIa in liver transplantation. Liver Transpl. (2005) 11:973-979.
  • PEDEN M, MCGEE K, SHARMA G: The Injury Chart Book: A Graphical Overview Of The Global Burden Of Injuries. Geneva: World Health Organization (2002).
  • CARRICO CJ, HOLCOMB JB, CHAUDRY IH: PULSE Trauma Work Group. Post Resuscitative and Initial Utility of Life Saving Efforts. Scientific priorities and strategic planning for resuscitation research and life saving therapy following traumatic injury: report of the PULSE Trauma Work Group. Acad. Emerg. Med. (2002) 9:621-626.
  • MOCK C, QUANSAH R, KRISHNAN R, ARRELOLA-RISA C, RIVARA F et al.: Strengthening the prevention and care of injuries worldwide. Lancet (2004) 363(9427):2172-2179.
  • MURRAY CJ, LOPEZ AD: Mortality by cause for eight regions of the world: Global Burden of Disease Study. Lancet (1997) 349:1269-1276.
  • WHO: World Health Report: 2003: shaping the future. (2003).
  • SAUAIA A, MOORE FA, MOORE EE et al.: Epidemiology of trauma deaths: a reassessment. J. Trauma (1995) 38:185-193.
  • MACKENZIE EJ, SIEGEL JH, SHAPIRO S, MOODY M, SMITH RT: Functional recovery and medical costs of trauma: an analysis by type and severity of injury. J. Trauma (1988) 28:281-297.
  • HOLBROOK TL, ANDERSON JP, SIEBER W, BROWNER D, HOYT DB: Outcome after major trauma: 12-month and 18-month follow-up results from the Trauma Recovery Project. J. Trauma (1999) 46:765-771.
  • GROUNDS M: Recombinant Factor VIIa (rFVIIa) and its use in severe bleeding in surgery and trauma: a review. Blood Rev. (2003) 17:S11-S21.
  • SPIVEY M, PARR MJ: Therapeutic approaches in trauma-induced coagulopathy. Minerva Anestesiol. (2005) 71(6):281-289.
  • MACLEOD JB, LYNN M, MCKENNEY MG et al.: Early coagulopathy predicts mortality in trauma. J. Trauma (2003) 55:39-44.
  • LYNN M, JEROUKHIMOV I, KLEIN Y, MARTINOWITZ U: Updates in the management of severe coagulopathy in trauma patients. Intensive Care Med. (2002) 28(2):S241-S247.
  • DUTTON RP, MCCUNN M, HYDER M et al.: Factor VIIa for correction of traumatic coagulopathy. J. Trauma (2004) 57:709-719.
  • SHANDER A: Emerging risks and outcomes of blood transfusion in surgery. Semin. Hematol. (2004) 41(1):117-124.
  • COMO JJ, DUTTON RP, SCALEA TM et al.: Blood transfusion rates in the care of acute trauma. Transfusion (2004) 44(6):809-813.
  • MALONE DL, DUNNE J, TRACY JK et al.: Blood transfusion, independent of shock severity, is associated with worse outcome in trauma. J. Trauma (2003) 54:898-905.
  • VASLEF SN, KNUDSEN NW, NELIGAN PJ, SEBASTIAN HW: Massive transfusion exceeding 50 units of blood products in trauma patients. J. Trauma (2002) 53(2):291-295.
  • TREGGIARI MM, HUDSON LD, MARTIN DP, WEISS NS, CALDWELL E, RUBENFELD G: Effect of acute lung injury and acute respiratory distress syndrome on outcome in critically ill trauma patients. Crit. Care Med. (2004) 32:327-331.
  • MOORE FA, SAUAIA A, MOORE EE et al.: Postinjury multiple organ failure: a bimodal phenomenon. J. Trauma (1996) 40:501-510.
  • ROTONDO MF, ZONIES DH: The damage control sequence and underlying logic. Surg. Clin. North Am. (1997) 77:761-777.
  • SHAFI S, KAUDER DR: Fluid resuscitation and blood replacement in patients with polytrauma. Clin. Orthop. Relat. Res. (2004) 422:37-42.
  • COATS T, ROBERTS I, SHAKUR H: Antifibrinolytic drugs for acute traumatic injury. Cochrane Database Syst. Rev. (2004) 4:CD004896.pub2. DOI: 10.1002/14651858.CD004896.pub2.
  • KENET G, WALDEN R, ELDAD A et al.: Treatment of traumatic bleeding with recombinant Factor VIIa. Lancet (1999) 354:1879.
  • STEIN DM, DUTTON RP: Uses of recombinant Factor VIIa in trauma. Curr. Opin. Crit. Care (2004) 10:520-528.
  • GOODNOUGH LT, LUBLIN DM, ZHANG L et al.: Transfusion medicine service policies for recombinant Factor VIIa administration. Transfusion (2004) 44(9):1325-1331.
  • BARLETTA JF, AHRENS CL, TYBURSKI JG, WILSON RF: A review of recombinant Factor VII for refractory bleeding in nonhemophilic trauma patients. J. Trauma (2005) 58(3):646-651.
  • MARTINOWITZ U, KENET G, SEGAL E et al.: Recombinant activated Factor VII for adjunctive hemorrhage control in trauma. J. Trauma (2001) 51:431-439.
  • MARTINOWITZ U, KENET G, LUBETSKI A et al.: Possible role of recombinant activated Factor VII (rFVIIa) in the control of hemorrhage associated with massive trauma. Can. J. Anesth. (2002) 49:S15-S20.
  • DUTTON RP, HESS JR, SCALEA TM: Recombinant Factor VIIa for control of hemorrhage: early experience in critically ill trauma patients. J. Clin. Anesth. (2003) 15:184-188.
  • EIKELBOOM JW, BIRD R, BLYTHE D et al.: Recombinant activated Factor VII for the treatment of life-threatening hemorrhage. Blood Coagul. Fibrinolysis (2003) 14:713-717.
  • BOFFARD KD, RIOU B, WARREN B et al.: Recombinant Factor VIIa as adjunctive therapy for bleeding control in severely injured trauma patients: two parallel randomized, placebo controlled, double-blind clinical trials. J. Trauma (2005) 59:8-18.
  • RIOU B, BOFFARD K, WARREN B et al.: Recombinant Factor VIIa (NovoSeven) as adjunctive therapy for bleeding control in trauma – a randomized, placebo-controlled trial. Shock (2004) 21(2):76.
  • ROSSAINT R, BOFFARD KD, WARREN BL et al.: Decreased transfusion utilization using recombinant Factor VIIa as an adjunct in trauma. Crit. Care Med. (2004) 30(1):S199. Abstract 771.
  • ROSSAINT R, RIOU B, BOFFARD K et al.: A randomised, placebo-controlled, double-blind study to investigate the efficacy and safety of rFVIIa as adjunctive therapy for control of bleeding in patients with severe blunt trauma – a re-analysis following exclusion of early (< 48 hours) deaths. Critical Care (2005) 9(1):S142. Abstract P337.

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