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| Sponsor: | Midwest Pulmonary and Critical Care |
|---|---|
| Collaborator: |
Genentech |
| Information provided by (Responsible Party): | GEORGE THOMMI, 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 |
|---|---|
|
Pleural Effusion Associated With Pulmonary Infection Bacterial Pleural Effusion Other Than Tuberculosis |
Procedure: intrapleural instillation of activase |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Crossover Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| 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: | September 2011 |
| Primary Completion Date: | October 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
1
EITHER 25mg OF ACTIVASE OR PLACEBO INSTILLED. RESPONSE TO THERAPY AFTER THREE DAYS. CROSS OVER TO THE OTHER DRUG IF NO RESPONSE
|
Procedure: intrapleural instillation of activase
CHEST TUBE PLACEMENT. INTRAPLEURAL INSTILLATION OF ACTIVASE OR PLACEBO
Other Names:
|
|
2
IF 1ST ARM FAILS THEN THE 2ND ARM (CROSSOVER TO EITHER PLACEBO OR ACTIVASE (NOT USED IN THE FIRST ARM) DILUTED IN 100CC OF NORMAL SALINE IS INSTILLED INTRAPLERUALLY
|
Procedure: intrapleural instillation of activase
CHEST TUBE PLACEMENT. INTRAPLEURAL INSTILLATION OF ACTIVASE OR PLACEBO
Other Names:
|
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 |
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
Contacts and Locations| 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 |
More Information
| Responsible Party: | GEORGE THOMMI, MD, Midwest Pulmonary and Critical Care |
| ClinicalTrials.gov Identifier: | NCT00468104 History of Changes |
| Other Study ID Numbers: | 11415 |
| Study First Received: | April 29, 2007 |
| Last Updated: | September 17, 2011 |
| Health Authority: | United States: Food and Drug Administration |
|
parapneumonic pleural effusion empyema TPA (ACTIVASE) |
|
Empyema Pleural Effusion Tuberculosis Suppuration Infection Inflammation Pathologic Processes Pleural Diseases Respiratory Tract Diseases Mycobacterium Infections Actinomycetales Infections |
Gram-Positive Bacterial Infections Bacterial Infections Tissue Plasminogen Activator Fibrinolytic Agents Fibrin Modulating Agents Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Cardiovascular Agents Therapeutic Uses Hematologic Agents |