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

Completed · Not applicable · Has a placebo group

Conditions studied: Pleural Effusion Associated With Pulmonary Infection, Bacterial Pleural Effusion Other Than Tuberculosis

In brief

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

Key facts

Study ID

NCT00468104

Run by

Midwest Pulmonary and Critical Care

People needed

100

Starts

2004-04-01

Expected to finish

2009-08-01

Last updated by the study team

2012-04-30

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Nebraska Methodist Hospital — Omaha, Nebraska, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.