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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
Sponsor:
Information provided by (Responsible Party):
Fayez Kheir,MD,MSc, Tulane University

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.

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

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


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 32 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

Drug Information available for: Alteplase

Arm Intervention/treatment
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




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Number of days with chest drainage [ Time Frame: 12 week follow up period ]
    Number of days with chest drainage

  2. Total length of hospital stay [ Time Frame: 12 week follow up period ]
    Total days spent in the hospital

  3. Failure rate of assigned treatment necessitating intervention [ Time Frame: 12 week follow up period ]
    1. Need for surgical intervention (VATS, Open Thoracotomy) in any arm
    2. Need for additional chest tube and/or fibrinolytic therapy in the medical thoracoscopy arm due to treatment failure
    3. Need of additional chest tube or additional fibrinolytic doses in the fibrinolytic therapy arm due to treatment failure

  4. Adverse events [ Time Frame: 12 week follow up period ]
    any Adverse events (pain, bleeding)

  5. In hospital and 30-day mortality [ Time Frame: 30 days ]
    Death of a patient while being hospitalized or up to 30 days after

  6. 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

  7. 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

  8. Total costs of each treatment modality [ Time Frame: 6 and 12 week follow up period ] ]
    Total costs of each treatment modality



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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


Information from the National Library of Medicine

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


Contacts
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Contact: Sanket Thakore, MD 504-988-3541 sthakore@tulane.edu
Contact: Fayez Kheir, MD, MSc 504-988-3541 fkheir@tulane.edu

Locations
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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    sthakore@tulane.edu   
Sub-Investigator: Sanket Thakore, MD         
Sponsors and Collaborators
Tulane University
Investigators
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Principal Investigator: Fayez Kheir, MD, MSc Tulane University

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Responsible Party: Fayez Kheir,MD,MSc, MD, MSc, Tulane University
ClinicalTrials.gov Identifier: NCT03468933     History of Changes
Other Study ID Numbers: 1070390
First Posted: March 19, 2018    Key Record Dates
Last Update Posted: May 31, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Infection
Communicable Diseases
Empyema
Pleural Diseases
Suppuration
Inflammation
Pathologic Processes
Respiratory Tract Diseases
Plasminogen
Tissue Plasminogen Activator
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action