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

Pleural Effusion Clinical Trial

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 Pleural Empyema

Clinical Trial 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)

Clinical Trial Description

n/a

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT01246453
Study type Interventional
Source Hospital Universitari Vall d'Hebron Research Institute
Contact
Status Completed
Phase Phase 4
Start date December 2003
Completion date December 2010
View Details
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