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See also:

  • All DVT prophylaxis clinical trials
  • All clinical trials of new anticoagulants
  • All clinical trials of rivaroxaban
    		•  

    ODIXa-HIP 10mg study, 2006

    Facebook    pdf : rivaroxaban - antithrombotics for DVT prophylaxis

    Treatments

    Studied treatment rivaroxaban 10mg daily for 5–9 days
    initiated 6 to 8 hours after surgery
    Control treatment once-daily subcutaneous enoxaparin dose of 40 mg for 5–9 days
    started on the evening before surgery and at least 6 to 8 hours after wound closure in accordance with European practice
    Remarks dose finding study (doses of 5, 10, 20, 30, or 40 mg)
    Treatments description
    enoxaprin regimen started before surgery  
    treatment duration 5–9 days 

    Patients

    Patients patients undergoing elective total hip replacement
    Baseline characteristics
    Age (mean), years 64 y 
    Total hip replacement 100% 
    Total knee replacement 0% 
    Weight, kg, 75.6 kg 
    Female 63% 
    general anesthesia 35% 

    Method and design

    Randomized effectives 142 / 157 (studied vs. control)
    Design Parallel groups
    Blinding double blind
    Follow-up duration 5-9 days
    Number of centre 48
    Geographic area Europe, Israel
    Hypothesis Superiority
    Primary endpoint any DVT, PE, all cause death


    Results

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

    non-fatal pulmonary embolism

    0 / 113
         0 / 107
         classic 0,95 [0,00;240,53]

    proximal DVT

    3 / 113
         3 / 107
         classic 0,95 [0,20;4,59]

    total VTE and all-cause mortality

    12 / 113
         27 / 107
         0,42 [0,22;0,79]

    distal DVT

    9 / 113
         24 / 107
         0,36 [0,17;0,73]

    Deep vein thrombosis

    12 / 113
         27 / 107
         0,42 [0,22;0,79]     0 2 1.0

    Relative risks
    Endpoint Events (%) Relative Risk 95% CI Endpoint definition
    in the trial    		 Ref
    Studied treat. Control treat.
    non-fatal pulmonary embolism 0 / 113 (0,4%) 0 / 107 (0,5%) 0,95 [0,02;47,30]    
    proximal DVT 3 / 113 (2,7%) 3 / 107 (2,8%) 0,95 [0,20;4,59]    
    total VTE and all-cause mortality 12 / 113 (10,6%) 27 / 107 (25,2%) 0,42 [0,22;0,79]    
    distal DVT 9 / 113 (8,0%) 24 / 107 (22,4%) 0,36 [0,17;0,73]    
    Deep vein thrombosis 12 / 113 (10,6%) 27 / 107 (25,2%) 0,42 [0,22;0,79]    
    The primary endpoint (if exists) appears in blod characters
    Reference(s) used for data extraction:

    Endpoint studied treat. control treat. mean diff

    Absolute risk reduction
    Endpoint Events rate Absolute risk
    reduction (ARR)
    Studied treat. Control treat.
    proximal DVT 2,65% 2,80% -1,5‰
    total VTE and all-cause mortality 10,62% 25,23% -146,1‰
    distal DVT 7,96% 22,43% -144,7‰
    Deep vein thrombosis 10,62% 25,23% -146,1‰

    Meta-analysis of all similar trials:

    anticoagulant in DVT prophylaxis for orthopedic surgery

    antithrombotics in DVT prophylaxis for orthopedic surgery

    antithrombotics in DVT prophylaxis for elective hip replacement

    direct factor Xa inhibitors in DVT prophylaxis for all type of patients

    new anticoagulants in DVT prophylaxis for all type of patients

    new anticoagulants in DVT prophylaxis for elective hip replacement



    Reference(s)

    Trials register # NA
    • Eriksson BI, Borris L, Dahl OE, Haas S, Huisman MV, Kakkar AK, Misselwitz F, Kälebo P. Oral, direct Factor Xa inhibition with BAY 59-7939 for the prevention of venous thromboembolism after total hip replacement.. J Thromb Haemost 2006 Jan;4:121-8
      Pubmed | Hubmed | Fulltext
    • Eriksson BI, Borris LC, Dahl OE, Haas S, Huisman MV, Kakkar AK, Muehlhofer E, Dierig C, Misselwitz F, Kälebo P. A once-daily, oral, direct Factor Xa inhibitor, rivaroxaban (BAY 59-7939), for thromboprophylaxis after total hip replacement.. Circulation 2006 Nov 28;114:2374-81
      Pubmed | Hubmed | Fulltext

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