N/A N=100 Randomized Quadruple-blind Treatment

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

Pleural Effusion Associated With Pulmonary Infection · Bacterial Pleural Effusion Other Than Tuberculosis

Bottom Line

View on ClinicalTrials.gov: NCT00468104 ↗

Enrolled (actual)

100

Serious AEs

1.1%

Results posted

Apr 2012

Primary outcome: Primary: No Surgical Intervention — 66; 6 participants — p=<0.001

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Alteplase (Drug); Placebo (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Midwest Pulmonary and Critical Care
Primary completion: Oct 2008

Outcome Measures

Outcome	Result	p-value
PRIMARY No Surgical Intervention	66; 6	<0.001 sig
SECONDARY Number of Participants With Pneumonia That Responded to Therapy	—	—
SECONDARY Number of Participants With Pleural Effusion/Empyema That Responded to Therapy	—	—
SECONDARY Number of Participants With Shortness of Breath That Responded to Therapy	—	—
SECONDARY Number of Participants With Clinical Symptoms of Sepsis That Responded to Therapy	—	—

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

Eligibility 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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00468104). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.