Clinical Trial: Efficacy and Security of Intrapleurally Alteplase vs Urokinase for the Treatment of Complicated Parapneumonic Effusion and Empyema

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional



Official Title: A Prospective, Randomized, Double Blind, Controlled Trial to Evaluate Efficacy and Security of Intrapleurally Alteplase vs Urokinase for the Treatment of Complicated Parapneumonic Effusion and

Brief Summary:

  1. Objectives:

    • Main objective: To evaluate the efficacy and safety of intrapleural alteplase vs urokinase in patients with complex complicated parapneumonic pleural effusion and empyema.
    • To evaluate the pleural and plasmatic levels of the fibrinolytic system markers after the treatment with alteplase vs urokinase
    • To evaluate the safety of alteplase in the treatment of complex complicated parapneumonic pleural effusion and empyema
  2. Design: Multicentric, randomized, parallel, controlled and double blind
  3. Main variable: Percentage of curation
  4. Study population and number of patients: 204 patients with complex complicated parapneumonic pleural effusions and empyema
  5. Duration of the treatment: Three days (main variable), and optional three days (secondary variable)