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

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)

Timeline

Start

2003-12

Primary completion

2010-12

Completion

2010-12

Publications

• Aleman C, Porcel JM, Alegre J, Ruiz E, Bielsa S, Andreu J, Deu M, Sune P, Martinez-Sogues M, Lopez I, Pallisa E, Schoenenberger JA, Bruno Montoro J, de Sevilla TF. Intrapleural Fibrinolysis with Urokinase Versus Alteplase in Complicated Parapneumonic Pleural Effusions and Empyemas: A Prospective Randomized Study. Lung. 2015 Dec;193(6):993-1000. doi: 10.1007/s00408-015-9807-6. Epub 2015 Sep 30.

Drugs

Indications