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See also:

  • All venous thrombosis clinical trials
  •  

    Ramacciotti study, 2004

    Treatments

    Studied treatment home treatment by once daily Subcutaneous injection of enoxaparin at a dose of 1.5 mg/kg for 5-10 days
    Control treatment in hospital intravenous bolus injection of 5000 IU of UFH followed by intravenous 500 IU/kg/day adjusted to maintain an aPTT of 1.5-2.5 times the normal value for 5-10 days.
    Remarks warfarin (with a targeted INR 2-3) for at least 3 months, starting at day 1 or 2 of treatment.

    Patients

    Patients patienst with DVT symptoms for greater than or equal to 10 days and proximal lower limb DVT confirmed by duplex ultrasound or venography
    Inclusion criteria Age greater than or equal to 18 years, weight greater than or equal to 50 and < 110kg,ready access to local health service, capable of using enoxaparin at home
    Exclusion criteria History of HIT or allergy to heparin, haemorrhagic diathesis, surgery within 7 days, symptoms of PE, bilateral DVT, survival prognaosis < 6 months, hepatic or renal failure, received therapeutic doses of UFH or LMWH for greater than or equal to 24 hrs in the previous 48 hrs, patients in hospital for another reason, with stay anticipated to last > 3days, initial platelet count <100,000/ml, uncontrolled hypertension with DBP greater than or equal to 180, initial APTT > 1.3 time the normal value, INR> 1.5 at enrollment, indication for thrombolysis or venous thrombectomy

    Method and design

    Randomized effectives 104 / 97 (studied vs. control)
    Design Parallel groups
    Blinding open
    Number of centre multicenter
    Geographic area Brazil


    Results

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

    Recurrent thromboembolic event

    2 / 104
    7 / 97
    0,27 [0,06;1,25]

    Minor bleeding

    12 / 104
    9 / 97
    classic 1,24 [0,55;2,82]

    Major bleeding

    2 / 104
    2 / 97
    classic 0,93 [0,13;6,49]

    All cause death

    0 / 104
    0 / 97
    classic 0,93 [0,00;236,78]
    0 2 1.0

    Relative risks
    Endpoint Events (%) Relative Risk 95% CI Endpoint definition
    in the trial
    Studied treat. Control treat.
    Recurrent thromboembolic event 2 / 104 (1,9%) 7 / 97 (7,2%) 0,27 [0,06;1,25]  
    Minor bleeding 12 / 104 (11,5%) 9 / 97 (9,3%) 1,24 [0,55;2,82]  
    Major bleeding 2 / 104 (1,9%) 2 / 97 (2,1%) 0,93 [0,13;6,49]  
    All cause death 0 / 104 (0,5%) 0 / 97 (0,5%) 0,93 [0,02;46,55]  
    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 1,92% 7,22% -52,9‰
    Minor bleeding 11,54% 9,28% 2,3%
    Major bleeding 1,92% 2,06% -1,4‰


    Reference(s)

    Trials register # NA
    • Ramacciotti E, Araújo GR, Lastoria S, Maffei FH, Karaoglan de Moura L, Michaelis W, Sandri JL, Dietrich-Neto F. An open-label, comparative study of the efficacy and safety of once-daily dose of enoxaparin versus unfractionated heparin in the treatment of proximal lower limb deep-vein thrombosis.. Thromb Res 2004;114:149-53
      Pubmed | Hubmed | Fulltext

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