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See also:

  • All venous thrombosis clinical trials
    		•  

    Chong study, 2005

    Treatments

    Studied treatment once daily sub-cutaneous injection of enoxaparin 1.5mg/kg for a minimum of 5 days plus 10mg of warfarin for 3 months adjusted to achieve INR above 2 and within range accepted by the investigator
    Control treatment 5000 IU bolus of unfractionated heparin (UFH) for a minimum of 5 days plus 10mg warfarin started on day 1 of the treatment for 3 months

    Patients

    Patients patients with diagnosis of symptomatic lower extrimity DVT (proimal or distal) confirmed by either contrast venography and/or ultrasonography, be suitable for treatment in an outpatient setting
    Inclusion criteria pateints be prepared to self administer daily sub cutaneous injections, life expectancy >6months
    Exclusion criteria 1) received therapeutic doses of heparin for more than 24 hours before randomisation; 2) clinically overt signs or symptoms of PE or evidence of PE on lung scaning or pulmonary angiography; 3) impendinding venous gangrene; 4) prevoius heparin -induced thrombocytopenia or another hypersensitivity reaction to heparin; 5) a platelet count <50 x 10/9 per litre; treantment with fibrinolytics or oral anticoagulants within the previous 5 days, or with other investigational therapeutic agents within the previous 4 weeks; 6) pregnancy or lactation; 7) any clinical significant medical condition other than DVT that would prevent the patient from being discharged from hospital

    Method and design

    Randomized effectives 150 / 148 (studied vs. control)
    Design Parallel groups
    Blinding open
    Follow-up duration 24 months
    Geographic area Australia, New Zealand, Poland, South Africa
    Primary endpoint symptomatic recurrent DVT


    Results

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

    Recurrent thromboembolic event

    4 / 150
         14 / 148
         0,28 [0,09;0,84]

    Minor bleeding

    15 / 150
         17 / 148
         0,87 [0,45;1,68]

    Major bleeding

    0 / 150
         3 / 148
         classic 0,08 [0,00;4,41]

    All cause death

    2 / 150
         2 / 148
         classic 0,99 [0,14;6,91]     0 2 1.0

    Relative risks
    Endpoint Events (%) Relative Risk 95% CI Endpoint definition
    in the trial
    Studied treat. Control treat.
    Recurrent thromboembolic event 4 / 150 (2,7%) 14 / 148 (9,5%) 0,28 [0,09;0,84]  
    Minor bleeding 15 / 150 (10,0%) 17 / 148 (11,5%) 0,87 [0,45;1,68]  
    Major bleeding 0 / 150 (0,3%) 3 / 148 (2,0%) 0,16 [0,01;3,25]  
    All cause death 2 / 150 (1,3%) 2 / 148 (1,4%) 0,99 [0,14;6,91]  
    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.
    Recurrent thromboembolic event 2,67% 9,46% -67,9‰
    Minor bleeding 10,00% 11,49% -14,9‰
    All cause death 1,33% 1,35% -0,2‰


    Reference(s)

    Trials register # NA
    • Chong BH, Brighton TA, Baker RI, Thurlow P, Lee CH. Once-daily enoxaparin in the outpatient setting versus unfractionated heparin in hospital for the treatment of symptomatic deep-vein thrombosis.. J Thromb Thrombolysis 2005;19:173-81
      Pubmed | Hubmed | Fulltext

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