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See also:

  • All venous thrombosis clinical trials
  •  

    Lee study, 2003

    Treatments

    Studied treatment LMWH, 200 IU/kg qd followed by Dalteparin 150 IU/kg qd
    Control treatment LMWH, 200 IU/kg qd followed by Warfarin target INR 2-3

    Patients

    Patients patients with cancer and objective diagnosis of DVT by Venography/compression ultrasonography
    Baseline characteristics
    objective DVT diagnosis Venography/CUS 
    objective PR diagnosis HCT/PA/VPLS 
    cancer (%) 100% 
    Outcome assessment blinded Yes 

    Method and design

    Randomized effectives 336 / 336 (studied vs. control)
    Blinding open
    Follow-up duration 6 mo
    Number of centre multicenter
    Primary endpoint recurrent thrombosis


    Results

    Endpoint Studied treat.
    n/N
    Control treat.
    n/N
    Graph RR [95% CI]

    VTE during active anticoagulant treatment

    27 / 336
    53 / 336
    0,51 [0,33;0,79]
    0 2 1.0

    Relative risks
    Endpoint Events (%) Relative Risk 95% CI Endpoint definition
    in the trial
    Studied treat. Control treat.
    VTE during active anticoagulant treatment 27 / 336 (8,0%) 53 / 336 (15,8%) 0,51 [0,33;0,79]  
    The primary endpoint (if exists) appears in blod characters

    Endpoint studied treat. control treat. mean diff

    Absolute risk reduction
    Endpoint Events rate Absolute risk
    reduction (ARR)
    Studied treat. Control treat.
    VTE during active anticoagulant treatment 8,04% 15,77% -77,4‰


    Reference(s)

    Trials register # NA
    • Lee AY, Levine MN, Baker RI, Bowden C, Kakkar AK, Prins M, Rickles FR, Julian JA, Haley S, Kovacs MJ, Gent M. Low-molecular-weight heparin versus a coumarin for the prevention of recurrent venous thromboembolism in patients with cancer.. N Engl J Med 2003;349:146-53
      Pubmed | Hubmed | Fulltext
    • Lee AY, Rickles FR, Julian JA, Gent M, Baker RI, Bowden C, Kakkar AK, Prins M, Levine MN. Randomized comparison of low molecular weight heparin and coumarin derivatives on the survival of patients with cancer and venous thromboembolism.. J Clin Oncol 2005;23:2123-9
      Pubmed | Hubmed | Fulltext

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