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

NCT ID: NCT00468104

Last Updated: 2012-04-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2004-04-30
• Study Completion Date: 2009-08-31

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.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Alteplase, Placebo- intapleural instillation

Either 25 mg of Alteplase or Placebo instilled daily. Response to therapy after three days. cross over to the other drug if no response was noted.

Group Type: ACTIVE_COMPARATOR

Alteplase

Intervention Type: DRUG

25 Mg of Alteplase in 100 cc of normal saline was instilled intrapeurally for daily for three days

Placebo

Intervention Type: DRUG

Placebo in 100 cc of normal saline was instilled intrapleurally daily for three days

Placebo, Alteplase -2nd arm

If the first arm fails then the 2nd arm ( cross over to either Placebo or Alteplase not used in the first arm) instilled intrapleurally daily for three days

Group Type: ACTIVE_COMPARATOR

Alteplase

Intervention Type: DRUG

25 Mg of Alteplase in 100 cc of normal saline was instilled intrapeurally for daily for three days

Placebo

Intervention Type: DRUG

Placebo in 100 cc of normal saline was instilled intrapleurally daily for three days

Interventions

Alteplase

25 Mg of Alteplase in 100 cc of normal saline was instilled intrapeurally for daily for three days

Intervention Type: DRUG

Placebo

Placebo in 100 cc of normal saline was instilled intrapleurally daily for three days

Intervention Type: DRUG

Other Intervention Names

TPA, Activase

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Genentech, Inc.

INDUSTRY

Sponsor Role: collaborator

Midwest Pulmonary and Critical Care

OTHER

Sponsor Role: lead

Responsible Party

GEORGE THOMMI

MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

George Thommi, MD

Role: PRINCIPAL_INVESTIGATOR

Midwest Pulmonary and Critical Care, PC

Locations

Nebraska Methodist Hospital

Omaha, Nebraska, United States

Countries

United States

Other Identifiers

11415

Identifier Type: -

Identifier Source: org_study_id