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Sponsors and Collaborators: |
Midwest Pulmonary and Critical Care Genentech |
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Information provided by: | Midwest Pulmonary and Critical Care |
ClinicalTrials.gov Identifier: | NCT00468104 |
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 |
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 |
Estimated Enrollment: | 90 |
Study Start Date: | April 2004 |
Estimated Study Completion Date: | April 2008 |
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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
• Diagnosed with complicated pleural effusions
Exclusion Criteria:
Active internal bleeding
Known bleeding diathesis including but not limited to:
Traumatic pleural effusion
Contact: GEORGE THOMMI, MD | 402 390 0606 | TOMMI4@COX.NET |
Contact: MATHEW MCLEAY, MD | 402 390 0606 |
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 |
Principal Investigator: | GEORGE THOMMI, MD | MIDWEST PULMONARY AND CRITICAL CARE, PC |
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 |
CPE(COMPLICATED PLEURAL EFFUSIONS) TPA (ACTIVASE) |
Pleural Effusion Fibrin Modulating Agents Respiratory Tract Diseases Pleural Diseases Tissue Plasminogen Activator Suppuration |
Fibrinolytic Agents Empyema Cardiovascular Agents Plasminogen Inflammation |
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 |