Fibrinolysis Compared to Thoracoscopy for Pleural Infection
| Status: | Recruiting |
|---|---|
| Conditions: | Infectious Disease |
| Therapuetic Areas: | Immunology / Infectious Diseases |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 9/20/2018 |
| Start Date: | July 14, 2017 |
| End Date: | November 2019 |
| Contact: | Adnan Majid, MD FCCP |
| Email: | amajid@bidmc.harvard.edu |
| Phone: | (617) 632 8252 |
Fibrinolytic Therapy Versus Medical Thoracoscopy for Treatment of Pleural Infection: A Randomized Clinical Trial
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.
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
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
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
We found this trial at
1
site
330 Brookline Ave
Boston, Massachusetts 02215
Boston, Massachusetts 02215
617-667-7000
Principal Investigator: Adnan Majid, MD FCCP
Phone: 617-632-8252
Beth Israel Deaconess Medical Center Beth Israel Deaconess Medical Center (BIDMC) is one of the...
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