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Completed

NCT Number: NCT02973139

Fibrinolysis Compared to Thoracoscopy for Pleural Infection

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.

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Key information

Conditions

Pleural Infection Pleural Diseases Respiratory Tract Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Medical Thoracoscopy

Other

Medical thoracoscopy will be performed as per standard protocols.

Fibrinolytic Group

Other

Patients will receive intrapleural combination of TPA (10 mg) and DNAse (5 mg). Therapy will be given twice daily for a maximum of 6 doses

Primary outcomes

  1. Duration of hospital stay after intervention

    Time frame: 12 week follow up period

    Number of days hospitalized

Secondary outcomes

  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

    defined as any of the following:

    • Surgical intervention (VATS, open thoracotomy) in the medical thoracoscopy or fibrinolytic therapy arm
    • Need of additional chest tube and/or fibrinolytic therapy in the medical thoracoscopy arm due to clinical non-responsiveness
    • Need of additional chest tube in the fibrinolytic therapy arm due to clinical non-responsiveness

  4. Adverse events

    Time frame: 12 week follow up period

    Any adverse event (pain or 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 on Chest CT scan prior to randomization (day 0) to prior to chest tube removal measured by radiologist blinded to treatment allocation using image J software

    Time frame: 12 week follow up period

    Pleural fluid volume measured with CT scan

  7. Inflammatory biomarker (CRP) from randomization (day 0), at 6 weeks and 12 weeks respectively

    Time frame: at randomization and at 6 and12 week follow up visit

    Inflammatory biomarker measure

  8. Total costs of each treatment modality

    Time frame: 6 and 12 week follow up period

    Total cost of each of treatment modality

Sponsors and collaborators

Lead sponsor

Beth Israel Deaconess Medical Center

Other

Registry information

Official study title

Fibrinolytic Therapy Versus Medical Thoracoscopy for Treatment of Pleural Infection: A Randomized Clinical Trial

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Nov 25, 2016
Registry last updated
Dec 26, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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