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)

Detailed Summary:
Sponsor: Hospital Universitari Vall d'Hebron Research Institute

Current Primary Outcome: To evaluate the efficacy and safety of intrapleural alteplase vs urokinase in patients with complex complicated parapneumonic pleural effusion and empyema during one year of follow-up. [ Time Frame: Evaluation at three and 6 days of treatment ]

It will be also an evaluation at one month, six months and one year


Original Primary Outcome: To evaluate the efficacy and safety of intrapleural alteplase vs urokinase in patients with complex complicated parapneumonic pleural effusion and empyema. [ Time Frame: Evaluation at three and 6 days of treatment ]

It will be also an evaluation at one month, six months and one year


Current Secondary Outcome: To evaluate the pleural and plasmatic levels of the fibrinolytic system markers after the treatment with alteplase vs urokinase [ Time Frame: Evaluation at three and 6 days of treatment ]

Original Secondary Outcome: Same as current

Information By: Hospital Universitari Vall d'Hebron Research Institute

Dates:
Date Received: November 18, 2010
Date Started: December 2003
Date Completion:
Last Updated: July 15, 2011
Last Verified: July 2011