Bacterial Pleural Effusion Other Than Tuberculosis Clinical Trial
Official title:
Response to Instillation of Activase in the Pleural Cavity vs Placebo in the Management of Complicated Pleural Effusion/Empyema
The purpose of this study is to document the efficacy and safety of intrapleural instillation of Activase vs Placebo in the management of complicated pleural effusions and empyemas
The current treatments available for complicated pleural effusions (CPE) include chest tube
placement for drainage and IV antibiotics. If this fails and CPE occurs then in most
patients thoracotomy is performed. Patients that are not surgical candidates have image
guided catheter placement performed, sometimes multiple times. The American College of Chest
Physicians (ACCP) formed a CPE panel and published guidelines for treating CPE. Percutaneous
image-guided drainage is the most common approach for CPE. The panel recognizes the
cumulative data that supports the use of fibrinolytics, VATS, and thoracotomy. The CPE panel
acknowledged the lack of randomized clinical trials to determine efficacy and safety of
these modalities in CPE and strongly encourages the research to take place.
Fibrinolytic therapy is a relatively noninvasive, easy to use, and is relatively
inexpensive. If successful, it will prevent sepsis and septic shock, decrease hospital stay,
morbidity and mortality and prevent any surgical procedures. Multiple doses of fibrinolytics
have been used in CPE with no evidence of systemic anti-fibrinolytic activity. Complications
with these medications are also very uncommon and only isolated instances are reported. The
benefit from successful pleural drainage using these agents will decrease morbidity,
mortality, surgical procedures, and hospital stay.
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment