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EffIcicy and Safety of Activase vs Placebo in CPE/Empyemas
This study is currently recruiting participants.
Verified by Midwest Pulmonary and Critical Care, April 2007
First Received: April 29, 2007   Last Updated: May 1, 2007   History of Changes
Sponsors and Collaborators: Midwest Pulmonary and Critical Care
Genentech
Information provided by: Midwest Pulmonary and Critical Care
ClinicalTrials.gov Identifier: NCT00468104
  Purpose

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


Condition Intervention Phase
Complicated Pleural Effusions and Empyemas
Procedure: intrapleural instillation of activase
Phase IV

Drug Information available for: Alteplase Tissue-type plasminogen activator
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Double-Blind, Placebo Control, Crossover Assignment, Safety/Efficacy Study
Official Title: Response to Instillation of Activase in the Pleural Cavity vs Placebo in the Management of Complicated Pleural Effusion/Empyema

Further study details as provided by Midwest Pulmonary and Critical Care:

Primary Outcome Measures:
  • • 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) [ Time Frame: 3 TO 4 YEARS ]

Secondary Outcome Measures:
  • • 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 [ Time Frame: 3- 4 YEARS ]

Estimated Enrollment: 90
Study Start Date: April 2004
Estimated Study Completion Date: April 2008
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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) > 1.5
      • 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 (CPE)
      • 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 CVA
      • Intracranial hemorrhage
      • AV malformation or aneurysm
      • Intracranial neoplasm
      • Acute myocardial infarction
      • Acute pulmonary embolus
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00468104

Contacts
Contact: GEORGE THOMMI, MD 402 390 0606 TOMMI4@COX.NET
Contact: MATHEW MCLEAY, MD 402 390 0606

Locations
United States, Nebraska
Nebraska Methodist Hospital Recruiting
OMAHA, Nebraska, United States, 68114
Contact: WILLIAM LYDIATT, MD     402-354-4035        
Principal Investigator: GEORGE THOMMI, MD            
Sub-Investigator: MATHEW MCLEAY, MD            
Sub-Investigator: JOSEPH C SHEHAN, MD            
Sub-Investigator: KIM ROBISON, RN            
Sponsors and Collaborators
Midwest Pulmonary and Critical Care
Genentech
Investigators
Principal Investigator: GEORGE THOMMI, MD MIDWEST PULMONARY AND CRITICAL CARE, PC
  More Information

No publications provided

Study ID Numbers: 11415
Study First Received: April 29, 2007
Last Updated: May 1, 2007
ClinicalTrials.gov Identifier: NCT00468104     History of Changes
Health Authority: United States: Institutional Review Board

Keywords provided by Midwest Pulmonary and Critical Care:
CPE(COMPLICATED PLEURAL EFFUSIONS)
TPA (ACTIVASE)

Study placed in the following topic categories:
Pleural Effusion
Fibrin Modulating Agents
Respiratory Tract Diseases
Pleural Diseases
Tissue Plasminogen Activator
Suppuration
Fibrinolytic Agents
Empyema
Cardiovascular Agents
Plasminogen
Inflammation

Additional relevant MeSH terms:
Molecular Mechanisms of Pharmacological Action
Pleural Diseases
Hematologic Agents
Tissue Plasminogen Activator
Empyema
Fibrinolytic Agents
Cardiovascular Agents
Infection
Pharmacologic Actions
Inflammation
Pleural Effusion
Fibrin Modulating Agents
Pathologic Processes
Respiratory Tract Diseases
Therapeutic Uses
Suppuration

ClinicalTrials.gov processed this record on May 06, 2009