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: 0
• Participant gender: All

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
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Hospital Universitari Vall d'Hebron Research Institute
• Treatments: Tissue Plasminogen Activator

Criteria

Inclusion Criteria:

• Empyema and Complex Complicated Parapneumonic Pleural Effusion

Exclusion Criteria:

• Pregnancy or breastfeeding

• Critically illness

• Systemic anticoagulant treatment

• Coagulation Disorder

• Bronchopleural fistula

• Active bleeding

• Recent punction of noncompressive artery

• Stroke in the last 6 months

• Major intervention o major traumatism in the last 6 weeks

• Hypersensibility to urokinase or alteplase

• Severe Liver or kidney failure

• Inclusion in another interventional study in the last month