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:
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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
- Design: Multicentric, randomized, parallel, controlled and double blind
- Main variable: Percentage of curation
- Study population and number of patients: 204 patients with complex complicated parapneumonic pleural effusions and empyema
- 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 ]
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 ]
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