Skip to main content
OpenTrials
Completed

NCT Number: NCT03468933

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 complicated parapneumonic effusion (CPPE) in adults.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Pleural Infection Empyema Infections Inflammation Parapneumonic Effusion Pathologic Processes Pathological Conditions, Signs and Symptoms Pleural Diseases Respiratory Tract Diseases Suppuration

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Tulane Medical Center Tulane University Section of Pulmonary DiseasesTulane University Section of Pulmonary Diseases

New Orleans, Louisiana, 70112, 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: 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

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

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

Medical thoracoscopy

Procedure

Medical thoracoscopy will be performed as per standard protocols.

Other names: Pleuroscopy

Primary outcomes

  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 outcomes

  1. Total Length of Hospital Stay

    Time frame: 12 week follow up period

    Total days spent in the hospital

  2. Number of Participants Necessitating Intervention After the Assigned Treatment

    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

  3. Adverse Events

    Time frame: 12 week follow up period

    any Adverse events (pain, bleeding)

  4. In Hospital and 30-day Mortality

    Time frame: 30 days

    Death of a patient while being hospitalized or up to 30 days after

Sponsors and collaborators

Lead sponsor

Tulane University

Other

Registry information

Official study title

Intrapleural Tissue Plasminogen Activator and Deoxyribonuclease Therapy Versus Early Medical Thoracoscopy for Treatment of Pleural Infection: A Randomized Clinical Trial

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Mar 19, 2018
Registry last updated
Feb 4, 2021

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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.