EffIcicy and Safety of Activase vs Placebo in CPE/Empyemas

Condition(s) targeted: Pleural Effusion Associated With Pulmonary Infection; Bacterial Pleural Effusion Other Than Tuberculosis

Intervention: intrapleural instillation of activase (Procedure)

Phase: N/A

Status: Recruiting

Sponsored by: Midwest Pulmonary and Critical Care

Official(s) and/or principal investigator(s):
GEORGE THOMMI, MD, Principal Investigator, Affiliation: MIDWEST PULMONARY AND CRITICAL CARE, PC

Overall contact:
GEORGE THOMMI, MD, Phone: 402 390 0606, Email: TOMMI4@COX.NET

THE PURPOSE OF THIS STUDY IS TO DOCUMENT THE EFFACICY AND SAFETY OF INTRAPLEURAL INSTILLATION OF ACTIVASE VS PLACEBO IN THE MANAGEMT OF COMPLICATED PLERUAL EFFUSIONS AND EMPYEMAS

Official title: Response to Instillation of Activase in the Pleural Cavity vs Placebo in the Management of Complicated Pleural Effusion/Empyema

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome: • Surgical procedures (VATS or decortication ) will be reduced by at least 40% more with Activase than with placebo • Preventing recurrence of CPE within six weeks ( if effusion recurs with sepsis, needing medical therapy or interventional therapy)

Secondary outcome: • A 70% reduction of complicated pleural effusion • Improvement of clinical symptoms • A 70% improvement in pneumonia, pulmonary infiltrates, and atelectasis • Shorten hospital stay • Prevent placing multiple chest tubes or repositioning chest

Detailed description: The current treatments available for 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.

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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: Active internal bleeding; Know bleeding diathesis; Bronchopleural fistula; Known bleeding diathesis including but not limited to: 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

GEORGE THOMMI, MD, Phone: 402 390 0606, Email: TOMMI4@COX.NET

Nebraska Methodist Hospital, Omaha, Nebraska 68114, United States; Recruiting
WILLIAM LYDIATT, MD, Phone: 402-354-4035
GEORGE THOMMI, MD, Principal Investigator
MATHEW MCLEAY, MD, Sub-Investigator
JOSEPH C SHEHAN, MD, Sub-Investigator
KIM ROBISON, RN, Sub-Investigator

Starting date: April 2004
Last updated: September 17, 2011