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Volumn 209, Issue 1, 2009, Pages 68-74

A Phase 3b, Open-Label, Single-Group Immunogenicity and Safety Study of Topical Recombinant Thrombin in Surgical Hemostasis

Author keywords

[No Author keywords available]

Indexed keywords

ANTIBODY; RECOTHROM; THROMBIN; THROMBIN ANTIBODY; UNCLASSIFIED DRUG; WARFARIN;

EID: 67549111906     PISSN: 10727515     EISSN: None     Source Type: Journal    
DOI: 10.1016/j.jamcollsurg.2009.03.016     Document Type: Article
Times cited : (21)

References (16)
  • 1
    • 34047229067 scopus 로고    scopus 로고
    • Thrombin generation and fibrin clot structure
    • Wolberg A.S. Thrombin generation and fibrin clot structure. Blood Rev 21 (2007) 131-142
    • (2007) Blood Rev , vol.21 , pp. 131-142
    • Wolberg, A.S.1
  • 2
    • 33646484957 scopus 로고    scopus 로고
    • The clinical use and immunologic impact of thrombin in surgery
    • Lawson J.H. The clinical use and immunologic impact of thrombin in surgery. Semin Thromb Hemost 32 Suppl 1 (2006) 98-110
    • (2006) Semin Thromb Hemost , vol.32 , Issue.SUPPL. 1 , pp. 98-110
    • Lawson, J.H.1
  • 4
    • 34447629499 scopus 로고    scopus 로고
    • A phase 3, randomized, double-blind comparative study of the efficacy and safety of topical recombinant human thrombin and bovine thrombin in surgical hemostasis
    • Chapman W.C., Singla N., Genyk Y., et al. A phase 3, randomized, double-blind comparative study of the efficacy and safety of topical recombinant human thrombin and bovine thrombin in surgical hemostasis. J Am Coll Surg 205 (2007) 256-265
    • (2007) J Am Coll Surg , vol.205 , pp. 256-265
    • Chapman, W.C.1    Singla, N.2    Genyk, Y.3
  • 5
    • 44349193348 scopus 로고    scopus 로고
    • A comparison of recombinant thrombin to bovine thrombin as a hemostatic ancillary in patients undergoing peripheral arterial bypass and arteriovenous graft procedures
    • Weaver F.A., Lew W., Granke K., et al. A comparison of recombinant thrombin to bovine thrombin as a hemostatic ancillary in patients undergoing peripheral arterial bypass and arteriovenous graft procedures. J Vasc Surg 47 (2008) 1266-1273
    • (2008) J Vasc Surg , vol.47 , pp. 1266-1273
    • Weaver, F.A.1    Lew, W.2    Granke, K.3
  • 6
    • 67549088837 scopus 로고    scopus 로고
    • A phase 2 multicenter study of the safety and immunogenicity of recombinant thrombin (rThrombin) applied following burn wound excision prior to skin grafting
    • Greenhalgh D.G., Gamelli R.L., Collins J., et al. A phase 2 multicenter study of the safety and immunogenicity of recombinant thrombin (rThrombin) applied following burn wound excision prior to skin grafting. J Burn Care Res 29 (2008) S56
    • (2008) J Burn Care Res , vol.29
    • Greenhalgh, D.G.1    Gamelli, R.L.2    Collins, J.3
  • 7
    • 67549151438 scopus 로고    scopus 로고
    • Safety, immunogenicity, and efficacy of recombinant human thrombin as a topical surgical hemostat: integrated results for a multi-surgery phase 2 program; Abstract
    • Lockstadt H., Lawson J., Chapman W., et al. Safety, immunogenicity, and efficacy of recombinant human thrombin as a topical surgical hemostat: integrated results for a multi-surgery phase 2 program; Abstract. J Thromb Haemost 3 Suppl 1 (2005) P1441
    • (2005) J Thromb Haemost , vol.3 , Issue.SUPPL. 1
    • Lockstadt, H.1    Lawson, J.2    Chapman, W.3
  • 8
    • 67549122908 scopus 로고    scopus 로고
    • Recombinant thrombin: safety and immunogenicity in burn wound excision and grafting
    • Greenhalgh D.G., Gamelli R.L., Collins J., et al. Recombinant thrombin: safety and immunogenicity in burn wound excision and grafting. J Burn Care Res 30 (2009) 371-379
    • (2009) J Burn Care Res , vol.30 , pp. 371-379
    • Greenhalgh, D.G.1    Gamelli, R.L.2    Collins, J.3
  • 9
    • 0031732635 scopus 로고    scopus 로고
    • Risk and clinical significance of developing antibodies induced by topical thrombin preparations
    • Dorion R.P., Hamati H.F., Landis B., et al. Risk and clinical significance of developing antibodies induced by topical thrombin preparations. Arch Pathol Lab Med 122 (1998) 887-894
    • (1998) Arch Pathol Lab Med , vol.122 , pp. 887-894
    • Dorion, R.P.1    Hamati, H.F.2    Landis, B.3
  • 10
    • 0035165420 scopus 로고    scopus 로고
    • Immunologic impact and clinical outcomes after surgical exposure to bovine thrombin
    • Ortel T.L., Mercer M.C., Thames E.H., et al. Immunologic impact and clinical outcomes after surgical exposure to bovine thrombin. Ann Surg 233 (2001) 88-96
    • (2001) Ann Surg , vol.233 , pp. 88-96
    • Ortel, T.L.1    Mercer, M.C.2    Thames, E.H.3
  • 11
    • 14244252558 scopus 로고    scopus 로고
    • Antihuman factor V antibodies after use of relatively pure bovine thrombin
    • Lawson J.H., Lynn K.A., Vanmatre R.M., et al. Antihuman factor V antibodies after use of relatively pure bovine thrombin. Ann Thorac Surg 79 (2005) 1037-1038
    • (2005) Ann Thorac Surg , vol.79 , pp. 1037-1038
    • Lawson, J.H.1    Lynn, K.A.2    Vanmatre, R.M.3
  • 12
    • 0028203735 scopus 로고
    • Topical thrombin and acquired coagulation factor inhibitors: clinical spectrum and laboratory diagnosis
    • Ortel T.L., Charles L.A., Keller F.G., et al. Topical thrombin and acquired coagulation factor inhibitors: clinical spectrum and laboratory diagnosis. Am J Hematol 45 (1994) 128-135
    • (1994) Am J Hematol , vol.45 , pp. 128-135
    • Ortel, T.L.1    Charles, L.A.2    Keller, F.G.3
  • 14
    • 0034869336 scopus 로고    scopus 로고
    • On small-sample confidence intervals for parameters in discrete distributions
    • Agresti A., and Min Y. On small-sample confidence intervals for parameters in discrete distributions. Biometrics 57 (2001) 963-971
    • (2001) Biometrics , vol.57 , pp. 963-971
    • Agresti, A.1    Min, Y.2
  • 16
    • 0036890997 scopus 로고    scopus 로고
    • Immune responses to therapeutic proteins in humans-clinical significance, assessment and prediction
    • Koren E., Zuckerman A.L., and Mire-Sluis A.R. Immune responses to therapeutic proteins in humans-clinical significance, assessment and prediction. Curr Pharm Biotechnol 3 (2002) 349-360
    • (2002) Curr Pharm Biotechnol , vol.3 , pp. 349-360
    • Koren, E.1    Zuckerman, A.L.2    Mire-Sluis, A.R.3


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.