Pleural Diseases Clinical Trial
Official title:
Intrapleural Tissue Plasminogen Activator and Deoxyribonuclease Therapy Versus Early Medical Thoracoscopy for Treatment of Pleural Infection: A Randomized Clinical Trial
Verified date | January 2021 |
Source | Tulane University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The purpose of this prospective randomized clinical trial is to compare two currently accepted standard-of-care treatment strategies: Medical thoracoscopy as compared to instillation of intrapleural tissue Plasminogen Activator (TPA) and human recombinant Deoxyribonuclease (DNase) for the management of empyema or complicated parapneumonic effusion (CPPE) in adults.
Status | Completed |
Enrollment | 32 |
Est. completion date | December 30, 2019 |
Est. primary completion date | December 30, 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: Subjects >18 years old with: Evidence of empyema or complex parapneumonic effusion Exclusion Criteria: Age <18 years Pregnancy Inability to give informed written consent Previous thoracic surgery or thrombolytic therapy for pleural infection Medical thoracoscopy cannot be performed within 48 hours Hemodynamic instability or severe hypoxemia Non corrected coagulopathy Homogeneously echogenic effusion on pleural ultrasonography |
Country | Name | City | State |
---|---|---|---|
United States | Tulane Medical Center Tulane University Section of Pulmonary DiseasesTulane University Section of Pulmonary Diseases | New Orleans | Louisiana |
Lead Sponsor | Collaborator |
---|---|
Tulane University |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Duration of Hospital Stay After Intervention | duration of hospital stay in days from time of procedure to discharge from hospital. | 12 week follow up period | |
Secondary | Total Length of Hospital Stay | Total days spent in the hospital | 12 week follow up period | |
Secondary | Number of Participants Necessitating Intervention After the Assigned Treatment | Need for surgical intervention (VATS, Open Thoracotomy) in any arm
Need for additional chest tube and/or fibrinolytic therapy in the medical thoracoscopy arm due to treatment failure Need of additional chest tube or additional fibrinolytic doses in the fibrinolytic therapy arm due to treatment failure |
12 week follow up period | |
Secondary | Adverse Events | any Adverse events (pain, bleeding) | 12 week follow up period | |
Secondary | In Hospital and 30-day Mortality | Death of a patient while being hospitalized or up to 30 days after | 30 days |
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