12-h and 2-h Urokinase Regimes of Pulmonary Thromboembolism in China
Condition: Pulmonary Embolism; Thromboembolism
MeSH terms: Pulmonary Embolism; Embolism; Thromboembolism
Study type: Interventional
Phase: Phase 4

Summary: 
      Comparative trials of urokinase (UK) for 12 hours（UK-12h）or 24 hours (UK-24h) have produced
      similar results in acute pulmonary thromboembolism (PTE) thrombolysis. It is unclear whether
      the infusion time can be reduced further. The aim of this study was to investigate the
      efficacy and safety of weight adjusted dosage of UK-2h (20 000 IU/Kg) regime with the Uk-12h
      regime in selected patients with PTE in Chinese population.
    

Detailed description: 
      Pulmonary thromboembolism (PTE), a frequent life-threatening complication of deep vein
      thrombosis (DVT), is often underestimated and under diagnosed . Effective early treatment
      will decrease the mortality, reverse right heart dysfunction and reduce risk of chronic
      thromboembolic pulmonary hypertension (CTEPH) or post-thrombotic syndrome (PTS). Thrombolysis
      has proved to be the most rapid and effective therapy to reduce the obstruction of pulmonary
      circulation and normalize hemodynamic parameters. The ultimate goals of thombolytic therapy
      for this disease are to minimize early morbidity and mortality and to prevent recurrence
      without provoking excessive bleeding.

      Currently, the choice of thrombolytic agents and regimens (either UK or rt-PA) is mostly
      based on personal or regional preferences. A loading dose of UK 4400 IU/kg followed by 2200
      IU/kg/hour for 12 hours (UK-12h), or rt-PA 100 mg infusion over 2 hours are recommended for
      acute PTE treatment. However, increasing evidence suggest that UK infusion can be more
      concentrated and time can be further reduced. 100 mg/2 h of rt-PA and a novel dosing regimen
      of UK(3 million U/2 h) had been compared. The results indicated that a 2-h regimen of rt-PA
      and 2h UK exhibited similar efficacy and safety for treatment of acute PTE. UK-2h(20 000U/Kg)
      regimen combined with low molecular weight heparin (LMWH) had been used in Chinese
      population.No severe bleeding and allergic reaction occurred in the thrombolytic group. This
      dosage is much lower than that used by Goldhaber et al, but the efficacy was prominent. Until
      now,no study have been reported to compared UK-2h(20 000U/Kg) regimen with other UK
      regimens(such as UK-12h).

      A relative lower dosage of UK 2-h regimen with body weight adjusted may be an alternative
      choice for treating PTE patients in Chinese population.Considering lower cost and convenience
      of this regimen, the efficacy and safety between UK-2h regimen(20 000U/Kg) and ACCP-approved
      UK-12h regimen for treating acute PTE will be compared.The study is conducted on patients
      with massive PTE with shock or hypotension and/or if without shock or hypotension but with
      right ventricular dysfunction. The clinical efficacy, emboli dissolving efficacy and safety
      will be evaluated.
    

Intervention name(s): Urokinase; Urokinase
Intervention type(s): Drug; Drug
Intervention description(s): UK,bolus 4 400 U/kg followed by intravenous 2 200 U/kg•h for 12 hours; UK,20 000U/kg continuously intravenous infusion for 2 hours
Other intervention name(s): Urokinase,thrombolytic agent; Urokinase,thrombolytic agent
Intervention MeSH terms: Fibrinolytic Agents
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Thrombolytic therapy; Urokinase; Efficacy; Safety