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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 complicated 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: 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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Fibrinolytic therapy group | Active Comparator | Patients randomized to the Fibrinolytic group will receive intrapleural therapy of combined tissue plasminogen activator (tPA) and human recombinant deoxyribonuclease (DNase) via chest tube. |
|
| Medical Thoracoscopy group | Active Comparator | Patients randomized to the Thoracoscopy group will undergo medical thoracoscopy. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| tissue plasminogen activator (tPA) and human recombinant deoxyribonuclease (DNase) | Drug | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Total Length of Hospital Stay | Total days spent in the hospital | 12 week follow up period |
| Number of Participants Necessitating Intervention After the Assigned Treatment |
|
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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
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| Name | Affiliation | Role |
|---|---|---|
| Fayez Kheir, MD, MSc | Tulane University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tulane Medical Center Tulane University Section of Pulmonary DiseasesTulane University Section of Pulmonary Diseases | New Orleans | Louisiana | 70112 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Fibrinolytic Therapy Group | Patients randomized to the Fibrinolytic group will receive intrapleural therapy of combined tissue plasminogen activator (tPA) and human recombinant deoxyribonuclease (DNase) via chest tube. tissue plasminogen activator (tPA) and human recombinant deoxyribonuclease (DNase): 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 |
| FG001 | Medical Thoracoscopy Group | Patients randomized to the Thoracoscopy group will undergo medical thoracoscopy. Medical Thoracoscopy: Medical thoracoscopy will be performed as per standard protocols. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Fibrinolytic Therapy Group | Patients randomized to the Fibrinolytic group will receive intrapleural therapy of combined tissue plasminogen activator (tPA) and human recombinant deoxyribonuclease (DNase) via chest tube. tissue plasminogen activator (tPA) and human recombinant deoxyribonuclease (DNase): 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 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Duration of Hospital Stay After Intervention | duration of hospital stay in days from time of procedure to discharge from hospital. | All participants received one of the assigned intervention | Posted | Median | Inter-Quartile Range | days | 12 week follow up period |
|
The perioperative period until hospital discharge, an average of 4 weeks per participant
Definition of adverse event and/or serious adverse event, used to collect adverse event information does not differ from the clinicaltrials.gov.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Fibrinolytic Therapy Group | Patients randomized to the Fibrinolytic group will receive intrapleural therapy of combined tissue plasminogen activator (tPA) and human recombinant deoxyribonuclease (DNase) via chest tube. tissue plasminogen activator (tPA) and human recombinant deoxyribonuclease (DNase): 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 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Respiratory | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment | Hemothorax without hemodynamic instability and did not need transfusion, but was monitored in the intensive care unit overnight. Intraprocedural hypoxia that resolved with insertion of a supraglottic airway tube and oxygen therapy. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Fayez Kheir | Tulane University | 504-988-3541 | fkheir@tulane.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jul 1, 2017 | Jan 16, 2021 | Prot_002.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jul 1, 2017 | Jan 16, 2021 | SAP_003.pdf |
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| ID | Term |
|---|---|
| D004653 | Empyema |
| D010995 | Pleural Diseases |
| ID | Term |
|---|---|
| D013492 | Suppuration |
| D007239 | Infections |
| D007249 | Inflammation |
| D010335 | Pathologic Processes |
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| ID | Term |
|---|---|
| D010959 | Tissue Plasminogen Activator |
| D013906 | Thoracoscopy |
| ID | Term |
|---|---|
| D012697 | Serine Endopeptidases |
| D010450 | Endopeptidases |
| D010447 | Peptide Hydrolases |
| D006867 | Hydrolases |
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| Medical Thoracoscopy | Procedure | Medical thoracoscopy will be performed as per standard protocols. |
|
|
| 12 week follow up period |
| Adverse Events | any Adverse events (pain, 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 |
| BG001 | Medical Thoracoscopy Group | Patients randomized to the Thoracoscopy group will undergo medical thoracoscopy. Medical Thoracoscopy: Medical thoracoscopy will be performed as per standard protocols. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Ultrasonographic estimated pleural effusion volume,Moderate | Count of Participants | Participants |
|
| Number of subjects with community acquired pleural infection | Count of Participants | Participants |
|
Patients randomized to the Thoracoscopy group will undergo medical thoracoscopy. Medical Thoracoscopy: Medical thoracoscopy will be performed as per standard protocols. |
|
|
| Secondary | Total Length of Hospital Stay | Total days spent in the hospital | All participants received assigned intervention | Posted | Median | Inter-Quartile Range | days | 12 week follow up period |
|
|
|
| Secondary | Number of Participants Necessitating Intervention After the Assigned Treatment |
| All participants received assigned intervention | Posted | Count of Participants | Participants | 12 week follow up period |
|
|
|
| Secondary | Adverse Events | any Adverse events (pain, bleeding) | All participants received assigned intervention | Posted | Count of Participants | Participants | 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 | All participants received assigned intervention | Posted | Count of Participants | Participants | 30 days |
|
|
|
| 0 |
| 16 |
| 0 |
| 16 |
| 1 |
| 16 |
| EG001 | Medical Thoracoscopy Group | Patients randomized to the Thoracoscopy group will undergo medical thoracoscopy. Medical Thoracoscopy: Medical thoracoscopy will be performed as per standard protocols. | 1 | 16 | 0 | 16 | 1 | 16 |
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| D013568 |
| Pathological Conditions, Signs and Symptoms |
| D012140 | Respiratory Tract Diseases |
| D004798 |
| Enzymes |
| D045762 | Enzymes and Coenzymes |
| D057057 | Serine Proteases |
| D010960 | Plasminogen Activators |
| D001779 | Blood Coagulation Factors |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D001685 | Biological Factors |
| D004724 | Endoscopy |
| D003949 | Diagnostic Techniques, Surgical |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D019060 | Minimally Invasive Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
| D019616 | Thoracic Surgical Procedures |