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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 complex parapneumonic effusion (CPPE) in adults.
Background: Pleural infection (empyema or complex parapneumonic effusion (CPPE)) represents one of the most common clinical diagnoses encountered in clinical practice in the United States (US) It is associated with substantial morbidity and mortality despite advances in medical diagnostic and therapeutic strategies.
Objective: Compare two standard of care treatments: TPA/DNase vs early medical Thoracoscopy
Methods: We will conduct a prospective randomized clinical trial. We plan to enroll a total of 80 patients and randomize them to either Medical Thoracoscopy group or Fibrinolytic Therapy group.
Follow-up will be daily until hospital discharge and at 6 and 12 weeks in the outpatient setting
Primary Outcome: Duration of hospital stay after intervention
Secondary Outcome: Failure rate of assigned treatment and adverse events
Potential Outcome and Benefit: Determine best strategy for treating patients with pleural infection
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Thoracoscopy group | Active Comparator | Patients randomized to the Thoracoscopy group will undergo medical thoracoscopy. |
|
| Fibrinolytic group | Active Comparator | Patients randomized to the Fibrinolytic group will receive intrapleural therapy of combined tissue plasminogen activator (tPA) and human recombinant deoxyribonuclease (DNase) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Medical Thoracoscopy | Other | Medical thoracoscopy will be performed as per standard protocols. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Duration of hospital stay after intervention | Number of days hospitalized | 12 week follow up period |
| Measure | Description | Time Frame |
|---|---|---|
| Number of days with chest drainage | Number of days with chest drainage | 12 week follow up period |
| Total length of hospital stay | Total days spent in the hospital |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beth Israel Deaconess Medical Center | Boston | Massachusetts | 02215 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32421353 | Derived | Kheir F, Thakore S, Mehta H, Jantz M, Parikh M, Chee A, Kaphle U, Sisnega C, Fernandez-Bussy S, Majid A. Intrapleural Fibrinolytic Therapy versus Early Medical Thoracoscopy for Treatment of Pleural Infection. Randomized Controlled Clinical Trial. Ann Am Thorac Soc. 2020 Aug;17(8):958-964. doi: 10.1513/AnnalsATS.202001-076OC. |
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| ID | Term |
|---|---|
| D010995 | Pleural Diseases |
| ID | Term |
|---|---|
| D012140 | Respiratory Tract Diseases |
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| Fibrinolytic Group | Other | Patients will receive intrapleural combination of TPA (10 mg) and DNAse (5 mg). Therapy will be given twice daily for a maximum of 6 doses |
|
| 12 week follow up period |
| Failure rate of assigned treatment necessitating intervention | defined as any of the following:
| 12 week follow up period |
| Adverse events | Any adverse event (pain or bleeding) | 12 week follow up period |
| In hospital and 30-day mortality | Death of a patient while being hospitalized or up to 30 days after | 30 days |
| Change in pleural fluid volume on Chest CT scan prior to randomization (day 0) to prior to chest tube removal measured by radiologist blinded to treatment allocation using image J software | Pleural fluid volume measured with CT scan | 12 week follow up period |
| Inflammatory biomarker (CRP) from randomization (day 0), at 6 weeks and 12 weeks respectively | Inflammatory biomarker measure | at randomization and at 6 and12 week follow up visit |
| Total costs of each treatment modality | Total cost of each of treatment modality | 6 and 12 week follow up period |