Efficacy and Safety of Activase (Ateplase) vs Placebo in Complicated Pleural Effusions (CPE)/Empyemas

• Status: Completed
• Trial end date: 2009-08-01
• Target enrollment: 0
• Participant gender: All

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

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Midwest Pulmonary and Critical Care
• Collaborator: Genentech, Inc.
• Treatments: Tissue Plasminogen Activator

Criteria

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