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See also:

  • All venous thrombosis clinical trials
  •  

    Romera study, 2009

    Treatments

    Studied treatment tinzaparin SC 175 IU anti-Xa per kg once daily for 6 months
    Control treatment acenocoumarol for target INR 2-3 for 6 months after initial LMWH (until INR 2-3)

    Patients

    Patients patients with symptomatic proximal DVT of the lowerlimbs confirmed by compression duplex ultrasound scan
    Baseline characteristics
    cancer (%) 28.6% 

    Method and design

    Randomized effectives 119 / 122 (studied vs. control)
    Design Parallel groups
    Blinding open
    Follow-up duration 12 months
    Lost to follow-up NA
    Number of centre 2
    Geographic area Spain
    Primary endpoint symptomatic recurrent venous thromboembolism


    Results

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

    Recurrent thromboembolic event

    6 / 119
    13 / 122
    0,47 [0,19;1,20]

    puylmonary embolism

    4 / 119
    3 / 122
    classic 1,37 [0,31;5,98]

    Bleeding

    1 / 119
    3 / 122
    classic 0,34 [0,04;3,24]

    recurrent DVT

    2 / 119
    10 / 122
    0,21 [0,05;0,92]

    VTE during active anticoagulant treatment

    5 / 119
    7 / 122
    classic 0,73 [0,24;2,24]

    VTE during follow-up after active anticoagulant treatment

    1 / 119
    6 / 122
    0,17 [0,02;1,40]
    0 2 1.0

    Relative risks
    Endpoint Events (%) Relative Risk 95% CI Endpoint definition
    in the trial
    Studied treat. Control treat.
    Recurrent thromboembolic event 6 / 119 (5,0%) 13 / 122 (10,7%) 0,47 [0,19;1,20]  
    puylmonary embolism 4 / 119 (3,4%) 3 / 122 (2,5%) 1,37 [0,31;5,98] at the end of trial 
    Bleeding 1 / 119 (0,8%) 3 / 122 (2,5%) 0,34 [0,04;3,24]  
    recurrent DVT 2 / 119 (1,7%) 10 / 122 (8,2%) 0,21 [0,05;0,92] at the end of the trial 
    VTE during active anticoagulant treatment 5 / 119 (4,2%) 7 / 122 (5,7%) 0,73 [0,24;2,24]  
    VTE during follow-up after active anticoagulant treatment 1 / 119 (0,8%) 6 / 122 (4,9%) 0,17 [0,02;1,40]  
    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 5,04% 10,66% -56,1‰
    puylmonary embolism 3,36% 2,46% 9,0‰
    Bleeding 8,40‰ 2,46% -16,2‰
    recurrent DVT 1,68% 8,20% -65,2‰
    VTE during active anticoagulant treatment 4,20% 5,74% -15,4‰
    VTE during follow-up after active anticoagulant treatment 8,40‰ 4,92% -40,8‰


    Reference(s)

    Trials register # NA
    • Romera A, Cairols MA, Vila-Coll R, Martí X, Colomé E, Bonell A, Lapiedra O. A randomised open-label trial comparing long-term sub-cutaneous low-molecular-weight heparin compared with oral-anticoagulant therapy in the treatment of deep venous thrombosis.. Eur J Vasc Endovasc Surg 2009;37:349-56
      Pubmed | Hubmed | Fulltext

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