NCT01246453

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

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 204 (estimated)
• Sponsor: Hospital Universitari Vall d'Hebron Research Institute · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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)

Conditions

• Empyema, Pleural
• Pleural Effusion
• Pleural Diseases

Interventions

Type	Name	Description
DRUG	Intrapleurally Alteplase vs Intrapleurally Urokinase	Alteplase 10 mg and urokinase 100000 intrapleurally administered, once daily for three days and if necessary 6 days

Timeline

• Start date: 2003-12-01
• Primary completion: 2010-12-01
• Completion: 2010-12-01
• First posted: 2010-11-23
• Last updated: 2011-07-18

Locations

2 sites across 1 country: Spain