Back to resultsFibrinolysis Compared to Thoracoscopy for Pleural Infection
Primary Purpose
Pleural Infection, Empyema, Pleural Diseases
Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
tissue plasminogen activator (tPA) and human recombinant deoxyribonuclease (DNase)
Medical Thoracoscopy
Sponsored by
About this trial
This is an interventional treatment trial for Pleural Infection
Eligibility Criteria
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
Sites / Locations
- Tulane Medical Center Tulane University Section of Pulmonary DiseasesTulane University Section of Pulmonary Diseases
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Fibrinolytic therapy group
Medical Thoracoscopy group
Arm Description
Patients randomized to the Fibrinolytic group will receive intrapleural therapy of combined tissue plasminogen activator (tPA) and human recombinant deoxyribonuclease (DNase) via chest tube.
Patients randomized to the Thoracoscopy group will undergo medical thoracoscopy.
Outcomes
Primary Outcome Measures
Duration of Hospital Stay After Intervention
duration of hospital stay in days from time of procedure to discharge from hospital.
Secondary Outcome Measures
Total Length of Hospital Stay
Total days spent in the hospital
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
Adverse Events
any Adverse events (pain, bleeding)
In Hospital and 30-day Mortality
Death of a patient while being hospitalized or up to 30 days after
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03468933
Brief Title
Fibrinolysis Compared to Thoracoscopy for Pleural Infection
Official Title
Intrapleural Tissue Plasminogen Activator and Deoxyribonuclease Therapy Versus Early Medical Thoracoscopy for Treatment of Pleural Infection: A Randomized Clinical Trial
Study Type
Interventional
2. Study Status
Record Verification Date
January 2021
Overall Recruitment Status
Completed
Study Start Date
November 1, 2017 (Actual)
Primary Completion Date
December 30, 2019 (Actual)
Study Completion Date
December 30, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Tulane University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
Detailed Description
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: Investigators will conduct a prospective randomized clinical trial. Plan is to enroll total of 32 patients and randomize those patients 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
Potential Outcome and Benefit: Determine best strategy for treating patients with pleural infection
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pleural Infection, Empyema, Pleural Diseases, Parapneumonic Effusion
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
32 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Fibrinolytic therapy group
Arm Type
Active Comparator
Arm Description
Patients randomized to the Fibrinolytic group will receive intrapleural therapy of combined tissue plasminogen activator (tPA) and human recombinant deoxyribonuclease (DNase) via chest tube.
Arm Title
Medical Thoracoscopy group
Arm Type
Active Comparator
Arm Description
Patients randomized to the Thoracoscopy group will undergo medical thoracoscopy.
Intervention Type
Drug
Intervention Name(s)
tissue plasminogen activator (tPA) and human recombinant deoxyribonuclease (DNase)
Intervention Description
Patients will receive intrapleural combination of TPA (10 mg) and DNAse (5 mg). Therapy will be given twice daily for a maximum of 6 dose
Intervention Type
Procedure
Intervention Name(s)
Medical Thoracoscopy
Other Intervention Name(s)
Pleuroscopy
Intervention Description
Medical thoracoscopy will be performed as per standard protocols.
Primary Outcome Measure Information:
Title
Duration of Hospital Stay After Intervention
Description
duration of hospital stay in days from time of procedure to discharge from hospital.
Time Frame
12 week follow up period
Secondary Outcome Measure Information:
Title
Total Length of Hospital Stay
Description
Total days spent in the hospital
Time Frame
12 week follow up period
Title
Number of Participants Necessitating Intervention After the Assigned Treatment
Description
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
Time Frame
12 week follow up period
Title
Adverse Events
Description
any Adverse events (pain, bleeding)
Time Frame
12 week follow up period
Title
In Hospital and 30-day Mortality
Description
Death of a patient while being hospitalized or up to 30 days after
Time Frame
30 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Fayez Kheir, MD, MSc
Organizational Affiliation
Tulane University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Tulane Medical Center Tulane University Section of Pulmonary DiseasesTulane University Section of Pulmonary Diseases
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70112
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
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Fibrinolysis Compared to Thoracoscopy for Pleural Infection
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