Clinical trial NCT00468104: Efficacy and Safety of Activase (Ateplase) vs Placebo in Complicated Pleural Effusions (CPE)/Empyemas
Official title: Response to Instillation of Activase in the Pleural Cavity vs Placebo in the Management of Complicated Pleural Effusion/Empyema
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pleural Effusion Associated With Pulmonary Infection
Bacterial Pleural Effusion Other Than Tuberculosis
Keywords: parapneumonic pleural effusion
empyema
TPA (Activase, Alteplase)
Lead sponsor: Midwest Pulmonary and Critical Care
Sponsor class: OTHER
Collaborators: name: Genentech, Inc.
First posted: 2007-05-02
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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 performed. Patients that are not surgical candidates have image guided catheter placement performed, sometimes multiple times. The American College of Chest Physicians (ACCP) formed a CPE panel and published guidelines for treating CPE. Percutaneous image-guided drainage is the most common approach for CPE. The panel recognizes the cumulative data that supports the use of fibrinolytics, VATS, and thoracotomy. The CPE panel acknowledged the lack of randomized clinical trials to determine efficacy and safety of these modalities in CPE and strongly encourages the research to take place.

Fibrinolytic therapy is a relatively noninvasive, easy to use, and is relatively inexpensive. If successful, it will prevent sepsis and septic shock, decrease hospital stay, morbidity and mortality and prevent any surgical procedures. Multiple doses of fibrinolytics have been used in CPE with no evidence of systemic anti-fibrinolytic activity. Complications with these medications are also very uncommon and only isolated instances are reported. The benefit from successful pleural drainage using these agents will decrease morbidity, mortality, surgical procedures, and hospital stay.

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

Primary outcomes:
measure: No Surgical Intervention
timeFrame: patients were followed six weeks per protocol. Most patients treated with Alteplase were also followed for up to six months
Secondary outcomes:
measure: Number of Participants With Pneumonia That Responded to Therapy
timeFrame: 6 weeks
measure: Number of Participants With Pleural Effusion/Empyema That Responded to Therapy
timeFrame: 6 weeks
measure: Number of Participants With Shortness of Breath That Responded to Therapy
timeFrame: 6 weeks
measure: Number of Participants With Clinical Symptoms of Sepsis That Responded to Therapy
timeFrame: 6 weeks
Other outcomes:
Locations:
city: Omaha
country: United States
facility: Nebraska Methodist Hospital
state: Nebraska
Study officials:
affiliation: Midwest Pulmonary and Critical Care, PC
name: George Thommi, MD
role: PRINCIPAL_INVESTIGATOR
References: