Fibrinolysis Compared to Thoracoscopy for Pleural Infection

Pleural Diseases Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03468933
• Other study ID #: 1070390
• Status: Completed
• Phase: Phase 4
• Start date: November 1, 2017
• Est. completion date: December 30, 2019

Study information

• Verified date: January 2021
• Source: Tulane University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: December 30, 2019
• Est. primary completion date: December 30, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Communicable Diseases
• Empyema
• Infection
• Parapneumonic Effusion
• Pleural Diseases
• Pleural Infection

Intervention

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

Procedure:
• Medical Thoracoscopy
Medical thoracoscopy will be performed as per standard protocols.

Locations

Country	Name	City	State
United States	Tulane Medical Center Tulane University Section of Pulmonary DiseasesTulane University Section of Pulmonary Diseases	New Orleans	Louisiana

Sponsors (1)

Lead Sponsor	Collaborator
Tulane University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Total Length of Hospital Stay	Total days spent in the hospital	12 week follow up period
Secondary	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
Secondary	Adverse Events	any Adverse events (pain, bleeding)	12 week follow up period
Secondary	In Hospital and 30-day Mortality	Death of a patient while being hospitalized or up to 30 days after	30 days