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See also:

  • All venous thrombosis clinical trials
  •  

    Daskalopoulos study, 2005

    Treatments

    Studied treatment home treatment with single sub- cutaneous injection of LMWH (tinzaparin sodium) in a weight adjusted dose (175 anti Xa IU/Kg) daily for 6 months
    Control treatment Intravenous bolus of 5000IU UFH followed by intrvenous infusion of UFH for 5-7 days. APTT was measured after 4 hours of the initiation of heparin administration and was repeated 6 hours thereafter to reach the therapeutic range (ratio: 1.5-2.5). Oral an

    Patients

    Patients patients with acute proximal DVT confirmed by colour duplex UScan not more than 1 week onset
    Exclusion criteria Segmental deep venous thrombosis restricted to infrapopliteal deep veins or calfmuscles as determined by duplex ultrasonography, symptomatic or clinically suspected PE, history of recently diagnosed (within 12 months) DVT or PE, patient already on anticoagulant therapy, bleeding tendency objectively confirmed, hypersensitivity to heparin preparations or coumarin derivatives, uncontrolled hypertension, history of recently diagnosed (less than 1 month) cerebrovascular accident, intracranial artery aneurysm, infectious endocarditis, thrombocytopenia, active peptic ulcer, hepatic or renal failure, history of asthma, recent spinal or epidural anaesthesia or intraspinal paracentesis (less than 5 days), recent surgery (less than 5 days), recently performed thrombolysis or under antiplatelet therapy, body weight less than 35kg, pregnancy,illicit drug addiction, altered mental status or impaired cognitive function with inability to comply with study protocol

    Method and design

    Randomized effectives 55 / 53 (studied vs. control)
    Design Parallel groups
    Blinding open
    Lost to follow-up n=6
    Geographic area Greece


    Results

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

    Recurrent thromboembolic event

    5 / 55
    6 / 53
    classic 0,80 [0,26;2,47]

    Minor bleeding

    3 / 55
    3 / 53
    classic 0,96 [0,20;4,56]

    Major bleeding

    2 / 55
    4 / 53
    classic 0,48 [0,09;2,52]

    All cause death

    1 / 55
    2 / 53
    classic 0,48 [0,05;5,16]
    0 2 1.0

    Relative risks
    Endpoint Events (%) Relative Risk 95% CI Endpoint definition
    in the trial
    Studied treat. Control treat.
    Recurrent thromboembolic event 5 / 55 (9,1%) 6 / 53 (11,3%) 0,80 [0,26;2,47]  
    Minor bleeding 3 / 55 (5,5%) 3 / 53 (5,7%) 0,96 [0,20;4,56]  
    Major bleeding 2 / 55 (3,6%) 4 / 53 (7,5%) 0,48 [0,09;2,52]  
    All cause death 1 / 55 (1,8%) 2 / 53 (3,8%) 0,48 [0,05;5,16]  
    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 9,09% 11,32% -22,3‰
    Minor bleeding 5,45% 5,66% -2,1‰
    Major bleeding 3,64% 7,55% -39,1‰
    All cause death 1,82% 3,77% -19,6‰


    Reference(s)

    Trials register # NA
    • Daskalopoulos ME, Daskalopoulou SS, Tzortzis E, Sfiridis P, Nikolaou A, Dimitroulis D, Kakissis I, Liapis CD. Long-term treatment of deep venous thrombosis with a low molecular weight heparin (tinzaparin): a prospective randomized trial.. Eur J Vasc Endovasc Surg 2005;29:638-50
      Pubmed | Hubmed | Fulltext

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