Fibrinolysis Compared to Thoracoscopy for Pleural Infection
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|ClinicalTrials.gov Identifier: NCT03468933|
Recruitment Status : Recruiting
First Posted : March 19, 2018
Last Update Posted : May 31, 2019
|Condition or disease||Intervention/treatment||Phase|
|Pleural Infection Empyema Pleural Diseases Parapneumonic Effusion||Drug: tissue plasminogen activator (tPA) and human recombinant deoxyribonuclease (DNase) Procedure: Medical Thoracoscopy||Phase 4|
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
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||32 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Intrapleural Tissue Plasminogen Activator and Deoxyribonuclease Therapy Versus Early Medical Thoracoscopy for Treatment of Pleural Infection: A Randomized Clinical Trial|
|Actual Study Start Date :||November 1, 2017|
|Estimated Primary Completion Date :||December 30, 2019|
|Estimated Study Completion Date :||December 30, 2019|
Active Comparator: 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.
Drug: 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
Active Comparator: Medical Thoracoscopy group
Patients randomized to the Thoracoscopy group will undergo medical thoracoscopy.
Procedure: Medical Thoracoscopy
Medical thoracoscopy will be performed as per standard protocols.
Other Name: Pleuroscopy
- Duration of hospital stay after intervention [ Time Frame: 12 week follow up period ]duration of hospital stay in days from time of procedure to discharge from hospital.
- Number of days with chest drainage [ Time Frame: 12 week follow up period ]Number of days with chest drainage
- Total length of hospital stay [ Time Frame: 12 week follow up period ]Total days spent in the hospital
- Failure rate of assigned treatment necessitating intervention [ Time Frame: 12 week follow up period ]
- 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 [ Time Frame: 12 week follow up period ]any Adverse events (pain, bleeding)
- In hospital and 30-day mortality [ Time Frame: 30 days ]Death of a patient while being hospitalized or up to 30 days after
- Change in pleural fluid volume [ Time Frame: 12 week follow up period ]Change in pleural fluid volume on chest CT scan from randomization (day 0) to prior to chest tube removal measured by radiologist blinded to treatment allocation using image J software
- Inflammatory biomarker (CRP) from randomization (day 0), at 6 weeks and 12 weeks respectively [ Time Frame: 6 and 12 week follow up period ]Inflammatory biomarker measure
- Total costs of each treatment modality [ Time Frame: 6 and 12 week follow up period ] ]Total costs of each treatment modality
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03468933
|Contact: Sanket Thakore, MDfirstname.lastname@example.org|
|Contact: Fayez Kheir, MD, MScemail@example.com|
|United States, Louisiana|
|Tulane Medical Center Tulane University Section of Pulmonary DiseasesTulane University Section of Pulmonary Diseases||Recruiting|
|New Orleans, Louisiana, United States, 70112|
|Contact: Sanket Thakore, MD 504-988-3541 firstname.lastname@example.org|
|Sub-Investigator: Sanket Thakore, MD|
|Principal Investigator:||Fayez Kheir, MD, MSc||Tulane University|