Nadroparin for the Initial Treatment of Pulmonary Thromboembolism
Condition: Pulmonary Embolism; Thromboembolism; Vascular Diseases; Thrombosis
MeSH terms: Pulmonary Embolism; Thrombosis; Embolism; Thromboembolism; Vascular Diseases
Study type: Interventional
Phase: Phase 4

Summary: 
      Low-molecular-weight heparin (LWMH) appears to be at least as effective and safe as standard,
      unfractionated heparin (UFH)for the treatment of patients with deep vein thrombosis(DVT) and
      may also be so in patients with pulmonary thromboembolism (PTE). Only limited data are
      available on the evaluation of body weight adjusted LWMH and standard UFH for the initial
      treatment of PTE in Chinese population. The aim of this study is to determine whether body
      weight-adjusted, subcutaneous Nadroparin is as effective and safe as UFH for treatment of
      patients with objectively documented PTE.
    

Detailed description: 
      Low-molecular-weight heparin (LWMH) appears to be at least as effective and safe as standard,
      unfractionated heparin (UFH)for the treatment of patients with deep vein thrombosis(DVT) and
      may also be so in patients with pulmonary thromboembolism (PTE). Only limited data are
      available on the evaluation of body weight adjusted LWMH and standard UFH for the initial
      treatment of PTE in Chinese population.

      The aim of this study is to determine whether body weight-adjusted, subcutaneous Nadroparin
      is as effective and safe as UFH for treatment of patients with objectively documented PTE.

      An open-label, adjudicator-blinded, randomized controlled trial of patients with symptomatic
      non-massive PTE from 37 major hospitals in China is conducted . Intravenous UFH was
      administered received an initial bolus dose of 80 IU/kg, followed by a continuous infusion at
      an initial rate of 18 IU/kg /hour. The dose was subsequently adjusted by activated partial
      thromboplastin time (APTT) monitoring. LMWH (nadroparin) was administered subcutaneously at a
      dose of 86 anti-factor Xa IU/kg every 12 hours.

      Both treatments were overlapped with at least 3 months of warfarin therapy. Main outcome
      measures were combined end point of clinical effect, image improvement,Recurrent venous
      thromboembolism(VTE), major bleeding, and death within 14 days and 3 months of randomization.
    

Intervention name(s): Nadroparin; Unfractionated heparin(UFH)
Intervention type(s): Drug; Drug
Intervention description(s): LMWH is given with a weight adjusted dose of 86 international anti-factor Xa units of nadroparin (Fraxiparine) per kilogram of body weight(86 anti-factor Xa IU/kg) subcutaneously every 12 hours,which will be used at least 5-7 days.; UFH is received with an initial bolus dose of 80 IU per kilogram, followed by a continuous intravenous infusion at an initial rate of 18 IU per kilogram per hour. The dose is subsequently adjusted so that the activated partial thromboplastin time (APTT) would be 1.5 to 2.5 times the control value in normal subjects. The tests are performed 4 hours after the start of treatment, whenever a sub-therapeutic APTT had been measured after a dose adjustment, and otherwise daily.UFH will be used at least 5-7 days.
Other intervention name(s): Low moleculor weight hepatin; Standard Unfractionated heparin
Intervention MeSH terms: Heparin; Calcium heparin; Nadroparin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Heparin; Low molecular weight heparin; Safety; Efficacy; Cost effective