Status:
COMPLETED
Efficacy and Safety of Activase (Ateplase) vs Placebo in Complicated Pleural Effusions (CPE)/Empyemas
Lead Sponsor:
Midwest Pulmonary and Critical Care
Collaborating Sponsors:
Genentech, Inc.
Conditions:
Pleural Effusion Associated With Pulmonary Infection
Bacterial Pleural Effusion Other Than Tuberculosis
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
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
Detailed Description
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...
Eligibility Criteria
Inclusion
- Inclusion Criteria:
- Diagnosed with complicated pleural effusions
- Ability to provide written informed consent and comply with study assessments for the full duration of the study.
- Age \> 18 years
- Exclusion Criteria
- Current use of oral anticoagulants (e.g., warfarin sodium) with an International Normalized Ratio (INR) \>5- Activated partial thromboplastin time (aPPT) \> 80, Platelet count \< 100,000/mm3;
- Severe uncontrolled hypertension
- Recognized hypersensitivity to Activase; or any component of its formulation; Traumatic pleural effusion
- Pregnancy (positive pregnancy test)
- In another study for this condition
- Any other condition that the investigator believes would pose a significant hazard to the subject if the investigational therapy were initiated
- Participation in another simultaneous medical investigation
- Recent stroke
- Intracranial hemorrhage
- arteriovenous malformation or aneurysm
- Intracranial neoplasm
- Acute myocardial infarction
- Acute pulmonary embolus
Exclusion
Key Trial Info
Start Date :
April 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2009
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT00468104
Start Date
April 1 2004
End Date
August 1 2009
Last Update
April 30 2012
Active Locations (1)
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1
Nebraska Methodist Hospital
Omaha, Nebraska, United States, 68114