Fibrinolysis Compared to Thoracoscopy for Pleural Infection

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

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.

Study Overview

• Status: Completed
• Conditions: Pleural Diseases; Pleural Infection; Empyema; Parapneumonic Effusion
• Intervention / Treatment: Drug: tissue plasminogen activator (tPA) and human recombinant deoxyribonuclease (DNase); Procedure: Medical Thoracoscopy

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

• Study Type: Interventional
• Enrollment (Actual): 32
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Louisiana
    • New Orleans, Louisiana, United States, 70112
      • Tulane Medical Center Tulane University Section of Pulmonary DiseasesTulane University Section of Pulmonary Diseases

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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 Names: Pleuroscopy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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	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	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

Collaborators and Investigators

• Sponsor: Tulane University
• Investigators: Principal Investigator: Fayez Kheir, MD, MSc, Tulane University

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2017
• Primary Completion (Actual): December 30, 2019
• Study Completion (Actual): December 30, 2019

Study Registration Dates

• First Submitted: March 5, 2018
• First Submitted That Met QC Criteria: March 12, 2018
• First Posted (Actual): March 19, 2018

Study Record Updates

• Last Update Posted (Actual): February 4, 2021
• Last Update Submitted That Met QC Criteria: January 16, 2021
• Last Verified: January 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Respiratory Tract Diseases; Inflammation; Disease Attributes; Suppuration; Infections; Communicable Diseases; Pleural Diseases; Empyema; Molecular Mechanisms of Pharmacological Action; Fibrinolytic Agents; Fibrin Modulating Agents; Tissue Plasminogen Activator; Plasminogen
• Other Study ID Numbers: 1070390

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No