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See also:

  • All venous thrombosis clinical trials
  •  

    Merli study, 2001

    Treatments

    Studied treatment enoxaparin 1.5 mg/kg body weight once daily
    Control treatment S.c. enoxaparin at fixed dosages of 1.0 mg/kg of body weight twice daily
    Concomittant treatment Oral anticoagulation was started within 72 hours (INR 2 to 3) and continued for at least 3 months.

    Patients

    Patients patients with a symptomatic lower-extremity DVT confirmed by venography or ultrasonography (including patients with confirmed PE)
    Exclusion criteria more than 24 hours of previous treatment with heparin or warfarin; need for thrombolytic therapy; known haemorrhagic risk, including active haemorrhage, active intestinal ulcerative disease, known angiodysplasia; or eye, spinal or central nervous system surgery within the previous month; renal or hepatic insufficiency; allergy to heparin, protamine, porcine products, iodine, or contrast media; history of heparin associated thrombocytopenia or heparin- or warfarin-associated skin necrosis; treatment with other investigational therapeutic agents within the previous 4 weeks; inferior vena cava interruption; known pregnacy or lactation

    Method and design

    Randomized effectives 298 / 312 (studied vs. control)
    Design Parallel groups
    Blinding double blind
    Lost to follow-up 1 patients
    Number of centre multicentre
    Geographic area Europe, United States of America and Australia, image/pj


    Results

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

    Recurrent thromboembolic event

    13 / 298
    9 / 312
    classic 1,51 [0,66;3,49]

    All cause death

    11 / 298
    7 / 312
    classic 1,65 [0,65;4,19]

    Bleeding

    5 / 298
    4 / 312
    classic 1,31 [0,35;4,83]
    0 2 1.0

    Relative risks
    Endpoint Events (%) Relative Risk 95% CI Endpoint definition
    in the trial
    Studied treat. Control treat.
    Recurrent thromboembolic event 13 / 298 (4,4%) 9 / 312 (2,9%) 1,51 [0,66;3,49]  
    All cause death 11 / 298 (3,7%) 7 / 312 (2,2%) 1,65 [0,65;4,19]  
    Bleeding 5 / 298 (1,7%) 4 / 312 (1,3%) 1,31 [0,35;4,83]  
    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 4,36% 2,88% 1,5%
    All cause death 3,69% 2,24% 1,4%
    Bleeding 1,68% 1,28% 4,0‰


    Reference(s)

    Trials register # NA
    • Merli G, Spiro TE, Olsson CG, Abildgaard U, Davidson BL, Eldor A, Elias D, Grigg A, Musset D, Rodgers GM, Trowbridge AA, Yusen RD, Zawilska K. Subcutaneous enoxaparin once or twice daily compared with intravenous unfractionated heparin for treatment of venous thromboembolic disease.. Ann Intern Med 2001;134:191-202
      Pubmed | Hubmed | Fulltext

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