Efficacy and Safety of Activase (Ateplase) vs Placebo in Complicated Pleural Effusions (CPE)/Empy… (NCT00468104) | Clinical Trial Compass
CompletedNot Applicable
Efficacy and Safety of Activase (Ateplase) vs Placebo in Complicated Pleural Effusions (CPE)/Empyemas
United States100 participantsStarted 2004-04
Plain-language 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
Who can participate
Age range18 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
What they're measuring
1
No Surgical Intervention
Timeframe: patients were followed six weeks per protocol. Most patients treated with Alteplase were also followed for up to six months