메뉴 건너뛰기




Volumn 363, Issue 19, 2010, Pages 1791-1800

Safety of recombinant activated factor VII in randomized clinical trials

Author keywords

[No Author keywords available]

Indexed keywords

COAGULATING AGENT; PLACEBO; RECOMBINANT ACTIVATED FACTOR VII; UNCLASSIFIED DRUG;

EID: 78049498149     PISSN: 00284793     EISSN: 15334406     Source Type: Journal    
DOI: 10.1056/NEJMoa1006221     Document Type: Article
Times cited : (569)

References (40)
  • 1
    • 54949106943 scopus 로고    scopus 로고
    • Factor VIIa and its potential therapeutic use in bleeding-associated pathologies
    • Hedner U. Factor VIIa and its potential therapeutic use in bleeding-associated pathologies. Thromb Haemost 2008;100:557-62.
    • (2008) Thromb Haemost , vol.100 , pp. 557-562
    • Hedner, U.1
  • 2
    • 17044405174 scopus 로고    scopus 로고
    • Efficacy and safety of recombinant factor VIIa for treatment of severe bleeding: A systematic review
    • Levi M, Peters M, Büller HR. Efficacy and safety of recombinant factor VIIa for treatment of severe bleeding: a systematic review. Crit Care Med 2005;33:883-90.
    • (2005) Crit Care Med , vol.33 , pp. 883-890
    • Levi, M.1    Peters, M.2    Büller, H.R.3
  • 4
    • 33646487022 scopus 로고    scopus 로고
    • Mechanism of action of factor VIIa in the treatment of coagulopathies
    • Hedner U. Mechanism of action of factor VIIa in the treatment of coagulopathies. Semin Thromb Hemost 2006;32: Suppl 1:77-85.
    • (2006) Semin Thromb Hemost , vol.32 , Issue.SUPPL. 1 , pp. 77-85
    • Hedner, U.1
  • 5
    • 30944461398 scopus 로고    scopus 로고
    • Thromboembolic adverse events after use of recombinant human coagulation factor VIIa
    • O'Connell KA, Wood JJ, Wise RP, Lozier JN, Braun MM. Thromboembolic adverse events after use of recombinant human coagulation factor VIIa. JAMA 2006;295:293-8.
    • (2006) JAMA , vol.295 , pp. 293-298
    • O'Connell, K.A.1    Wood, J.J.2    Wise, R.P.3    Lozier, J.N.4    Braun, M.M.5
  • 6
    • 13844315293 scopus 로고    scopus 로고
    • Recombinant activated factor VII for acute intracerebral hemorrhage
    • Mayer SA, Brun NC, Begtrup K, et al. Recombinant activated factor VII for acute intracerebral hemorrhage. N Engl J Med 2005;352:777-85.
    • (2005) N Engl J Med , vol.352 , pp. 777-785
    • Mayer, S.A.1    Brun, N.C.2    Begtrup, K.3
  • 7
    • 11144246729 scopus 로고    scopus 로고
    • Safety and feasibility of recombinant factor VIIa for acute intracerebral hemorrhage
    • Mayer SA, Brun NC, Broderick J, et al. Safety and feasibility of recombinant factor VIIa for acute intracerebral hemorrhage. Stroke 2005;36:74-9.
    • (2005) Stroke , vol.36 , pp. 74-79
    • Mayer, S.A.1    Brun, N.C.2    Broderick, J.3
  • 13
    • 23744440522 scopus 로고    scopus 로고
    • Efficacy and safety of repeated perioperative doses of recombinant factor VIIa in liver transplantation
    • 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;11:973-9.
    • (2005) Liver Transpl , vol.11 , pp. 973-979
    • Lodge, J.P.1    Jonas, S.2    Jones, R.M.3
  • 14
    • 19944433743 scopus 로고    scopus 로고
    • Recombinant coagulation factor VIIa in major liver resection: A randomized, placebo-controlled, double-blind clinical trial
    • Lodge JP, Jonas S, Oussoultzoglou E, et al. Recombinant coagulation factor VIIa in major liver resection: a randomized, placebo-controlled, double-blind clinical trial. Anesthesiology 2005;102:269-75.
    • (2005) Anesthesiology , vol.102 , pp. 269-275
    • Lodge, J.P.1    Jonas, S.2    Oussoultzoglou, E.3
  • 15
    • 23744438763 scopus 로고    scopus 로고
    • Safety and efficacy of a single bolus administration of recombinant factor VIIa in liver transplantation due to chronic liver disease
    • 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.
    • (2005) Liver Transpl , vol.11 , pp. 895-900
    • Planinsic, R.M.1    Van Der Meer, J.2    Testa, G.3
  • 16
    • 31444433052 scopus 로고    scopus 로고
    • Safety and hemostatic effect of recombinant activated factor VII in cirrhotic patients undergoing partial hepatectomy: A multicenter, randomized, double-blind, placebo-controlled trial
    • Shao YF, Yang JM, Chau GY, et al. Safety and hemostatic effect of recombinant activated factor VII in cirrhotic patients undergoing partial hepatectomy: a multicenter, randomized, double-blind, placebo-controlled trial. Am J Surg 2006;191:245-9.
    • (2006) Am J Surg , vol.191 , pp. 245-249
    • Shao, Y.F.1    Yang, J.M.2    Chau, G.Y.3
  • 17
    • 24644491444 scopus 로고    scopus 로고
    • Recombinant factor VIIa as adjunctive therapy for bleeding control in severely injured trauma patients: Two parallel randomized, placebo-controlled, double-blind clinical trials
    • 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;59:8-15.
    • (2005) J Trauma , vol.59 , pp. 8-15
    • Boffard, K.D.1    Riou, B.2    Warren, B.3
  • 18
    • 27744513120 scopus 로고    scopus 로고
    • Activated recombinant factor VII after cardiopulmonary bypass reduces allogeneic transfusion in complex non-coronary cardiac surgery: Randomized double-blind placebo-controlled pilot study
    • Diprose P, Herbertson MJ, O'Shaughnessy D, Gill RS. Activated recombinant factor VII after cardiopulmonary bypass reduces allogeneic transfusion in complex non-coronary cardiac surgery: randomized double-blind placebo-controlled pilot study. Br J Anaesth 2005;95:596-602.
    • (2005) Br J Anaesth , vol.95 , pp. 596-602
    • Diprose, P.1    Herbertson, M.J.2    O'Shaughnessy, D.3    Gill, R.S.4
  • 19
    • 33745431704 scopus 로고    scopus 로고
    • Elective administration in infants of low-dose recombinant activated factor VII (rFVIIa) in cardiopulmonary bypass surgery for congenital heart disease does not shorten time to chest closure or reduce blood loss and need for transfusions: A randomized, double-blind, parallel group, placebo-controlled study of rFVIIa
    • Ekert H, Brizard C, Eyers R, Cochrane A, Henning R. Elective administration in infants of low-dose recombinant activated factor VII (rFVIIa) in cardiopulmonary bypass surgery for congenital heart disease does not shorten time to chest closure or reduce blood loss and need for transfusions: a randomized, double-blind, parallel group, placebo-controlled study of rFVIIa and standard haemostatic replacement therapy versus standard haemostatic replacement therapy. Blood Coagul Fibrinolysis 2006;17:389-95.
    • (2006) Blood Coagul Fibrinolysis , vol.17 , pp. 389-395
    • Ekert, H.1    Brizard, C.2    Eyers, R.3    Cochrane, A.4    Henning, R.5
  • 20
    • 67651089555 scopus 로고    scopus 로고
    • Safety and efficacy of recombinant activated factor VII: A randomized placebo-controlled trial in the setting of bleeding after cardiac surgery
    • Gill R, Herbertson M, Vuylsteke A, et al. Safety and efficacy of recombinant activated factor VII: a randomized placebo-controlled trial in the setting of bleeding after cardiac surgery. Circulation 2009;120:21-7.
    • (2009) Circulation , vol.120 , pp. 21-27
    • Gill, R.1    Herbertson, M.2    Vuylsteke, A.3
  • 21
    • 48949119534 scopus 로고    scopus 로고
    • Recombinant factor VIIA in traumatic intracerebral hemorrhage: Results of a dose-escalation clinical trial
    • Narayan RK, Maas AI, Marshall LF, Servadei F, Skolnick BE, Tillinger MN. Recombinant factor VIIA in traumatic intracerebral hemorrhage: results of a dose-escalation clinical trial. Neurosurgery 2008;62:776-86.
    • (2008) Neurosurgery , vol.62 , pp. 776-786
    • Narayan, R.K.1    Maas, A.I.2    Marshall, L.F.3    Servadei, F.4    Skolnick, B.E.5    Tillinger, M.N.6
  • 22
    • 34848876646 scopus 로고    scopus 로고
    • Recombinant activated factor VII in spinal surgery: A multicenter, randomized, double-blind, placebo-controlled, dose-escalation trial
    • DOI 10.1097/BRS.0b013e3181557d45, PII 0000763220071001000002
    • Sachs B, Delacy D, Green J, et al. Recombinant activated factor VII in spinal surgery: a multicenter, randomized, double-blind, placebo-controlled, dose-escalation trial. Spine 2007;32:2285-93. (Pubitemid 47508833)
    • (2007) Spine , vol.32 , Issue.21 , pp. 2285-2293
    • Sachs, B.1    Delacy, D.2    Green, J.3    Graham, R.S.4    Ramsay, J.5    Kreisler, N.6    Kruse, P.7    Khutoryansky, N.8    Hu, S.S.9
  • 23
    • 27844454825 scopus 로고    scopus 로고
    • Control of bleeding in children with Dengue hemorrhagic fever using recombinant activated factor VII: A randomized, double-blind, placebo-controlled study
    • Chuansumrit A, Wangruangsatid S, Lektrakul Y, Chua MN, Zeta Capeding MR, Bech OM. Control of bleeding in children with Dengue hemorrhagic fever using recombinant activated factor VII: a randomized, double-blind, placebo-controlled study. Blood Coagul Fibrinolysis 2005;16:549-55. (Pubitemid 41658973)
    • (2005) Blood Coagulation and Fibrinolysis , vol.16 , Issue.8 , pp. 549-555
    • Chuansumrit, A.1    Wangruangsatid, S.2    Lektrakul, Y.3    Chua, M.N.4    Capeding, M.R.Z.5    Bech, O.M.6
  • 24
    • 0037452134 scopus 로고    scopus 로고
    • Effect of recombinant activated factor VII on perioperative blood loss in patients undergoing retropubic prostatectomy: A double-blind placebo-controlled randomised trial
    • Erratum, Lancet 2003;361:1138
    • Friederich PW, Henny CP, Messelink EJ, et al. Effect of recombinant activated factor VII on perioperative blood loss in patients undergoing retropubic prostatectomy: a double-blind placebo-controlled randomised trial. Lancet 2003;361:201-5. [Erratum, Lancet 2003;361:1138.]
    • (2003) Lancet , vol.361 , pp. 201-205
    • Friederich, P.W.1    Henny, C.P.2    Messelink, E.J.3
  • 26
    • 18144393811 scopus 로고    scopus 로고
    • Use of activated recombinant coagulation factor VII in patients undergoing reconstruction surgery for traumatic fracture of pelvis or pelvis and acetabulum: A double-blind, randomized, placebo-controlled trial
    • DOI 10.1093/bja/aei102
    • Raobaikady R, Redman J, Ball JA, Maloney G, Grounds RM. Use of activated recombinant coagulation factor VII in patients undergoing reconstruction surgery for traumatic fracture of pelvis or pelvis and acetabulum: a double-blind, randomized, placebo-controlled trial. Br J Anaesth 2005;94:586-91. (Pubitemid 40613802)
    • (2005) British Journal of Anaesthesia , vol.94 , Issue.5 , pp. 586-591
    • Raobaikady, R.1    Redman, J.2    Ball, J.A.S.3    Maloney, G.4    Grounds, R.M.5
  • 27
    • 0037069334 scopus 로고    scopus 로고
    • Ability of recombinant factor VIIa to reverse the anticoagulant effect of the pentasaccharide fondaparinux in healthy volunteers
    • Bijsterveld NR, Moons AH, Boekholdt SM, et al. Ability of recombinant factor VIIa to reverse the anticoagulant effect of the pentasaccharide fondaparinux in healthy volunteers. Circulation 2002;106:2550-4.
    • (2002) Circulation , vol.106 , pp. 2550-2554
    • Bijsterveld, N.R.1    Moons, A.H.2    Boekholdt, S.M.3
  • 29
    • 0032465250 scopus 로고    scopus 로고
    • The effect of recombinant factor VIIa (NovoSeven(TM)) in healthy volunteers receiving acenocoumarol to an International Normalized Ratio above 2.0
    • Erhardtsen E, Nony P, Dechavanne M, French P, Biossel JP, Hedner U. The effect of recombinant factor VIIa (NovoSeven) in healthy volunteers receiving acenocoumarol to an International Normalized Ratio above 2.0. Blood Coagul Fibrinolysis 1998;9:741-8. (Pubitemid 29144978)
    • (1998) Blood Coagulation and Fibrinolysis , vol.9 , Issue.8 , pp. 741-748
    • Erhardtsen, E.1    Nony, P.2    Dechavanne, M.3    Ffrench, P.4    Boissel, J.P.5    Hedner, U.6
  • 30
    • 18944386159 scopus 로고    scopus 로고
    • A study of the pharmacokinetics and safety of recombinant activated factor VII in healthy Caucasian and Japanese subjects
    • Fridberg MJ, Hedner U, Roberts HR, Erhardtsen E. A study of the pharmacokinetics and safety of recombinant activated factor VII in healthy Caucasian and Japanese subjects. Blood Coagul Fibrinolysis 2005;16:259-66. (Pubitemid 40705047)
    • (2005) Blood Coagulation and Fibrinolysis , vol.16 , Issue.4 , pp. 259-266
    • Fridberg, M.J.1    Hedner, U.2    Roberts, H.R.3    Erhardtsen, E.4
  • 31
    • 0035967490 scopus 로고    scopus 로고
    • Ability of recombinant factor VIIa to generate thrombin during inhibition of tissue factor in human subjects
    • Friederich PW, Levi M, Bauer KA, et al. Ability of recombinant factor VIIa to generate thrombin during inhibition of tissue factor in human subjects. Circulation 2001;103:2555-9.
    • (2001) Circulation , vol.103 , pp. 2555-2559
    • Friederich, P.W.1    Levi, M.2    Bauer, K.A.3
  • 32
    • 3042531845 scopus 로고    scopus 로고
    • Effect of recombinant factor VIIa on melagatraninduced inhibition of thrombin generation and platelet activation in healthy volunteers
    • Wolzt M, Levi M, Sarich TC, et al. Effect of recombinant factor VIIa on melagatraninduced inhibition of thrombin generation and platelet activation in healthy volunteers. Thromb Haemost 2004;91:1090-6.
    • (2004) Thromb Haemost , vol.91 , pp. 1090-1096
    • Wolzt, M.1    Levi, M.2    Sarich, T.C.3
  • 33
    • 0038581741 scopus 로고    scopus 로고
    • Age-related changes in risk factor effects on the incidence of thromboembolic and hemorrhagic stroke
    • Abbott RD, Curb JD, Rodriguez BL, et al. Age-related changes in risk factor effects on the incidence of thromboembolic and hemorrhagic stroke. J Clin Epidemiol 2003;56:479-86.
    • (2003) J Clin Epidemiol , vol.56 , pp. 479-486
    • Abbott, R.D.1    Curb, J.D.2    Rodriguez, B.L.3
  • 34
    • 28344456034 scopus 로고    scopus 로고
    • Venous thromboembolism: Disease burden, outcomes and risk factors
    • Heit JA. Venous thromboembolism: disease burden, outcomes and risk factors. J Thromb Haemost 2005;3:1611-7.
    • (2005) J Thromb Haemost , vol.3 , pp. 1611-1617
    • Heit, J.A.1
  • 35
    • 0032741802 scopus 로고    scopus 로고
    • Risk factors for venous thrombotic disease
    • Rosendaal FR. Risk factors for venous thrombotic disease. Thromb Haemost 1999;82:610-9.
    • (1999) Thromb Haemost , vol.82 , pp. 610-619
    • Rosendaal, F.R.1
  • 36
    • 0034639246 scopus 로고    scopus 로고
    • An epidemiologic study of risk factors for deep vein thrombosis in medical outpatients: The Sirius study
    • Samama MM. An epidemiologic study of risk factors for deep vein thrombosis in medical outpatients: the Sirius study. Arch Intern Med 2000;160:3415-20.
    • (2000) Arch Intern Med , vol.160 , pp. 3415-3420
    • Samama, M.M.1
  • 37
    • 44649180990 scopus 로고    scopus 로고
    • Safety update on recombinant factor VIIa in the treatment of congenital and acquired hemophilia
    • Abshire T. Safety update on recombinant factor VIIa in the treatment of congenital and acquired hemophilia. Semin Hematol 2008;45:Suppl:S3-S6.
    • (2008) Semin Hematol , vol.45
    • Abshire, T.1
  • 38
    • 13244262642 scopus 로고    scopus 로고
    • Comparative thrombotic event incidence after infusion of recombinant factor VIIa versus factor VIII inhibitor bypass activity
    • 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.
    • (2004) J Thromb Haemost , vol.2 , pp. 1700-1708
    • Aledort, L.M.1
  • 39
    • 36549084598 scopus 로고    scopus 로고
    • Increased mortality, postoperative morbidity, and cost after red blood cell transfusion in patients having cardiac surgery
    • Murphy GJ, Reeves BC, Rogers CA, Rizvi SI, Culliford L, Angelini GD. Increased mortality, postoperative morbidity, and cost after red blood cell transfusion in patients having cardiac surgery. Circulation 2007;116:2544-52.
    • (2007) Circulation , vol.116 , pp. 2544-2552
    • Murphy, G.J.1    Reeves, B.C.2    Rogers, C.A.3    Rizvi, S.I.4    Culliford, L.5    Angelini, G.D.6
  • 40
    • 33744499443 scopus 로고    scopus 로고
    • Recombinant factor VIIa in patients with coagulopathy secondary to anticoagulant therapy, cirrhosis, or severe traumatic injury: Review of safety profile
    • Levy JH, Fingerhut A, Brott T, Langbakke IH, Erhardtsen E, Porte RJ. Recombinant factor VIIa in patients with coagulopathy secondary to anticoagulant therapy, cirrhosis, or severe traumatic injury: review of safety profile. Transfusion 2006;46:919-33.
    • (2006) Transfusion , vol.46 , pp. 919-933
    • Levy, J.H.1    Fingerhut, A.2    Brott, T.3    Langbakke, I.H.4    Erhardtsen, E.5    Porte, R.J.6


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.