Overview

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

Status:
Completed

Trial end date:
2010-12-01

Target enrollment:

Participant gender:

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)

Phase:

Phase 4

Details

Lead Sponsor:

Hospital Universitari Vall d'Hebron Research Institute

Treatments:

Tissue Plasminogen Activator