Fibrinolysis Compared to Thoracoscopy for Pleural Infection

Phase 4

Completed

Conditions: Pleural Infection
Pleural Diseases
Parapneumonic Effusion
Empyema

Interventions: Drug: tissue plasminogen activator (tPA) and human recombinant deoxyribonuclease (DNase)
Procedure: Medical Thoracoscopy

Registration Number: NCT03468933

Lead Sponsor: 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.

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

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 32

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 & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Fibrinolytic therapy group	tissue plasminogen activator (tPA) and human recombinant deoxyribonuclease (DNase)	Patients randomized to the Fibrinolytic group will receive intrapleural therapy of combined tissue plasminogen activator (tPA) and human recombinant deoxyribonuclease (DNase) via chest tube.
Medical Thoracoscopy group	Medical Thoracoscopy	Patients randomized to the Thoracoscopy group will undergo medical thoracoscopy.

Primary Outcome Measures

Name	Time	Method
Duration of Hospital Stay After Intervention	12 week follow up period	duration of hospital stay in days from time of procedure to discharge from hospital.

Secondary Outcome Measures

Name	Time	Method
Total Length of Hospital Stay	12 week follow up period	Total days spent in the hospital
Number of Participants Necessitating Intervention After the Assigned Treatment	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
Adverse Events	12 week follow up period	any Adverse events (pain, bleeding)
In Hospital and 30-day Mortality	30 days	Death of a patient while being hospitalized or up to 30 days after

Trial Locations

Locations (1): Tulane Medical Center Tulane University Section of Pulmonary DiseasesTulane University Section of Pulmonary Diseases
🇺🇸
New Orleans, Louisiana, United States