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Volumn 220, Issue 1, 2015, Pages 70-81

The FINISH-3 trial: A phase 3, international, randomized, single-blind, controlled trial of topical fibrocaps in intraoperative surgical hemostasis

Author keywords

[No Author keywords available]

Indexed keywords

FIBRIN GLUE; FIBRINOGEN PLUS THROMBIN; GELATIN SPONGE; HEMOSTATIC AGENT; GELATIN;

EID: 84916897878     PISSN: 10727515     EISSN: 18791190     Source Type: Journal    
DOI: 10.1016/j.jamcollsurg.2014.09.019     Document Type: Conference Paper
Times cited : (26)

References (22)
  • 1
    • 77449138990 scopus 로고    scopus 로고
    • A comprehensive review of topical hemostatic agents: Efficacy and recommendations for use
    • H.E. Achneck, S. Bantayehu, and R.M. Jamiolowski A comprehensive review of topical hemostatic agents: Efficacy and recommendations for use Ann Surg 251 2010 217 228
    • (2010) Ann Surg , vol.251 , pp. 217-228
    • Achneck, H.E.1    Bantayehu, S.2    Jamiolowski, R.M.3
  • 2
    • 84871041165 scopus 로고    scopus 로고
    • Hemostats, sealants, and adhesives: A practical guide for the surgeon
    • W.D. Spotnitz Hemostats, sealants, and adhesives: a practical guide for the surgeon Am Surg 78 2012 1305 1321
    • (2012) Am Surg , vol.78 , pp. 1305-1321
    • Spotnitz, W.D.1
  • 3
    • 84885363323 scopus 로고    scopus 로고
    • An essential primer for understanding the role of topical hemostats, surgical sealants, and adhesives for maintaining hemostasis
    • M. Gabay, and B.A. Boucher An essential primer for understanding the role of topical hemostats, surgical sealants, and adhesives for maintaining hemostasis Pharmacotherapy 33 2013 935 955
    • (2013) Pharmacotherapy , vol.33 , pp. 935-955
    • Gabay, M.1    Boucher, B.A.2
  • 5
    • 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
    • W.C. Chapman, N. Singla, and Y. Genyk 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
  • 6
    • 33845382806 scopus 로고
    • Nonparametric estimation from incomplete observations
    • E.L. Kaplan, and P. Meier Nonparametric estimation from incomplete observations J Am Stat Assn 53 1958 457 481
    • (1958) J Am Stat Assn , vol.53 , pp. 457-481
    • Kaplan, E.L.1    Meier, P.2
  • 8
    • 0000172859 scopus 로고
    • The standard error of an estimate of expectational life
    • J.O. Irwin The standard error of an estimate of expectational life J Hygiene 47 1949 457 481
    • (1949) J Hygiene , vol.47 , pp. 457-481
    • Irwin, J.O.1
  • 9
    • 84857064999 scopus 로고    scopus 로고
    • US Department of Health and Human Services, National Institutes of Health, National Cancer Institute Accessed October 22, 2014
    • US Department of Health and Human Services, National Institutes of Health, National Cancer Institute. Common terminology criteria for adverse events (CTCAE). Version 4. Available at: http://evs.nci.nih.gov/ftp1/CTCAE/CTCAE-4.03-2010-06-14-QuickReference-5x7.pdf. Accessed October 22, 2014.
    • Common Terminology Criteria for Adverse Events (CTCAE). Version 4
  • 10
    • 84916914126 scopus 로고    scopus 로고
    • WHO. Drug Reference List (March 2010 version). Uppsala, Sweden: Uppsala-WHO Collaborating Centre for International Drug Monitoring
    • WHO. Drug Reference List (March 2010 version). Uppsala, Sweden: Uppsala-WHO Collaborating Centre for International Drug Monitoring; 2010.
  • 11
    • 0024560149 scopus 로고
    • Randomized clinical trial of fibrin sealant in patients undergoing resternotomy or reoperation after cardiac operations. A multicenter study
    • J. Rousou, S. Levitsky, and L. Gonzalez-Lavin Randomized clinical trial of fibrin sealant in patients undergoing resternotomy or reoperation after cardiac operations. A multicenter study J Thorac Cardiovasc Surg 97 1989 194 203
    • (1989) J Thorac Cardiovasc Surg , vol.97 , pp. 194-203
    • Rousou, J.1    Levitsky, S.2    Gonzalez-Lavin, L.3
  • 12
    • 34447537864 scopus 로고    scopus 로고
    • Evaluation of the topical hemostatic efficacy and safety of TISSEEL VH S/D fibrin sealant compared with currently licensed TISSEEL VH in patients undergoing cardiac surgery: A phase 3, randomized, double-blind clinical study
    • J. Lowe, J. Luber, and S. Levitsky Evaluation of the topical hemostatic efficacy and safety of TISSEEL VH S/D fibrin sealant compared with currently licensed TISSEEL VH in patients undergoing cardiac surgery: a phase 3, randomized, double-blind clinical study J Cardiovasc Surg (Torino) 48 2007 323 331
    • (2007) J Cardiovasc Surg (Torino) , vol.48 , pp. 323-331
    • Lowe, J.1    Luber, J.2    Levitsky, S.3
  • 13
    • 78449312811 scopus 로고    scopus 로고
    • Randomized clinical trial of tranexamic acid-free fibrin sealant during vascular surgical procedures
    • R.T. Chalmers, R.C. Darling III, and J.T. Wingard Randomized clinical trial of tranexamic acid-free fibrin sealant during vascular surgical procedures Br J Surg 97 2010 1784 1789
    • (2010) Br J Surg , vol.97 , pp. 1784-1789
    • Chalmers, R.T.1    Darling, R.C.2    Wingard, J.T.3
  • 14
    • 84916878478 scopus 로고    scopus 로고
    • Ethicon, Inc. Accessed June 12
    • Evicel Fibrin Sealant (Human) prescribing information. Ethicon, Inc. 2009. Available at: http://hostedvl106.quosavl.com/cgi-isapi/server.dll?8000?IFUs?rkumar12@its.jnj.com?GetOneDocPureFullTxt?24vnohukg3l4tbqe1t9fo4ahno?3. Accessed June 12, 2014.
    • (2009) Evicel Fibrin Sealant (Human) Prescribing Information
  • 15
    • 20144388773 scopus 로고    scopus 로고
    • Effectiveness of a new carrier-bound fibrin sealant versus argon beamer as haemostatic agent during liver resection: A randomised prospective trial
    • A. Frilling, G.A. Stavrou, and H.J. Mischinger Effectiveness of a new carrier-bound fibrin sealant versus argon beamer as haemostatic agent during liver resection: a randomised prospective trial Langenbecks Arch Surg 390 2005 114 120
    • (2005) Langenbecks Arch Surg , vol.390 , pp. 114-120
    • Frilling, A.1    Stavrou, G.A.2    Mischinger, H.J.3
  • 16
    • 78650176174 scopus 로고    scopus 로고
    • Hemostatic efficacy of TachoSil in liver resection compared with argon beam coagulator treatment: An open, randomized, prospective, multicenter, parallel-group trial
    • L. Fischer, C.M. Seiler, and C.E. Broelsch Hemostatic efficacy of TachoSil in liver resection compared with argon beam coagulator treatment: an open, randomized, prospective, multicenter, parallel-group trial Surgery 149 2011 48 55
    • (2011) Surgery , vol.149 , pp. 48-55
    • Fischer, L.1    Seiler, C.M.2    Broelsch, C.E.3
  • 17
    • 69849115358 scopus 로고    scopus 로고
    • TachoSil surgical patch versus conventional haemostatic fleece material for control of bleeding in cardiovascular surgery: A randomised controlled trial
    • F. Maisano, H.K. Kjaergård, and R. Bauernschmitt TachoSil surgical patch versus conventional haemostatic fleece material for control of bleeding in cardiovascular surgery: a randomised controlled trial Eur J Cardiothorac Surg 36 2009 708 714
    • (2009) Eur J Cardiothorac Surg , vol.36 , pp. 708-714
    • Maisano, F.1    Kjaergård, H.K.2    Bauernschmitt, R.3
  • 18
    • 84882749147 scopus 로고    scopus 로고
    • A prospective, randomized, controlled trial of the efficacy and safety of fibrin pad as an adjunct to control soft tissue bleeding during abdominal, retroperitoneal, pelvic, and thoracic surgery
    • C.P. Fischer, G. Bochicchio, and J. Shen A prospective, randomized, controlled trial of the efficacy and safety of fibrin pad as an adjunct to control soft tissue bleeding during abdominal, retroperitoneal, pelvic, and thoracic surgery J Am Coll Surg 217 2013 385 393
    • (2013) J Am Coll Surg , vol.217 , pp. 385-393
    • Fischer, C.P.1    Bochicchio, G.2    Shen, J.3
  • 20
    • 84916914125 scopus 로고    scopus 로고
    • European Medicines Agency. European Medicines Agency recommends new advice on safer use of fibrin sealant spray applications Accessed June 12, 2014
    • European Medicines Agency. European Medicines Agency recommends new advice on safer use of fibrin sealant spray applications. 2012. Available at: http://www.ema.europa.eu/ema/index.jsp?curl=pages/news-and-events/news/2012/12/news-detail-001674.jsp&mid=WC0b01ac058004d5c1. Accessed June 12, 2014.
    • (2012)
  • 21
    • 48249125452 scopus 로고    scopus 로고
    • Estimating the pathogen safety of manufactured human plasma products: Application to fibrin sealants and to thrombin
    • B. Horowitz, and M. Busch Estimating the pathogen safety of manufactured human plasma products: application to fibrin sealants and to thrombin Transfusion 48 2008 1739 1753
    • (2008) Transfusion , vol.48 , pp. 1739-1753
    • Horowitz, B.1    Busch, M.2


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.