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Objectives:
Design: Multicentric, randomized, parallel, controlled and double blind
Main variable: Percentage of curation
Study population and number of patients: 204 patients with complex complicated parapneumonic pleural effusions and empyema
Duration of the treatment: Three days (main variable), and optional three days (secondary variable)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| urokinase | Active Comparator |
| |
| Alteplase | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Intrapleurally Alteplase vs Intrapleurally Urokinase | Drug | Alteplase 10 mg and urokinase 100000 intrapleurally administered, once daily for three days and if necessary 6 days |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | It will be also an evaluation at one month, six months and one year | Evaluation at three and 6 days of treatment |
| Measure | Description | Time Frame |
|---|---|---|
| To evaluate the pleural and plasmatic levels of the fibrinolytic system markers after the treatment with alteplase vs urokinase | Evaluation at three and 6 days of treatment |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Vall d'Hebron | Barcelona | Catalonia | 5 | Spain | ||
| Hospital Arnau de Vilanova |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26423784 | Derived | 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. |
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| Lleida |
| Catalonia |
| Spain |
| ID | Term |
|---|---|
| D016724 | Empyema, Pleural |
| D010996 | Pleural Effusion |
| D010995 | Pleural Diseases |
| ID | Term |
|---|---|
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D004653 | Empyema |
| D013492 | Suppuration |
| D012140 | Respiratory Tract Diseases |
| D007249 | Inflammation |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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