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

NCT01246453 Phase 4 COMPLETED

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)

Details

Lead sponsor	Hospital Universitari Vall d'Hebron Research Institute
Phase	Phase 4
Status	COMPLETED
Enrolment	204
Start date	2003-12
Completion	2010-12

Conditions

• Empyema, Pleural
• Pleural Effusion
• Pleural Diseases

Interventions

• Intrapleurally Alteplase vs Intrapleurally Urokinase

Primary outcomes

• 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. — Evaluation at three and 6 days of treatment
  It will be also an evaluation at one month, six months and one year

Countries

Spain