Fibrinolysis Compared to Thoracoscopy for Pleural Infection

Not Applicable

Completed

• Conditions: Pleural Diseases; Pleural Infection
• Interventions: Other: Medical Thoracoscopy; Other: Fibrinolytic Group

• Registration Number: NCT02973139
• Lead Sponsor: Beth Israel Deaconess Medical Center

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 complex 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: 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

Study Timeline

• Study First Submitted: 2016-11-22
• Study First Submitted QC: 2016-11-22
• Study First Posted: 2016-11-25
• Study Start: 2017-07-14
• Primary Completion: 2019-11-01
• Study Completion: 2019-11-01
• Status Verified: 2019-12
• Last Update Submitted: 2019-12-24
• Last Update Posted: 2019-12-26

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

Primary Outcome Measures

Name	Time	Method
Duration of hospital stay after intervention	12 week follow up period	Number of days hospitalized

Secondary Outcome Measures

Name	Time	Method
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	12 week follow up period	Pleural fluid volume measured with CT scan
Number of days with chest drainage	12 week follow up period	Number of days with chest drainage
Total length of hospital stay	12 week follow up period	Total days spent in the hospital
Failure rate of assigned treatment necessitating intervention	12 week follow up period	defined as any of the following: 1. Surgical intervention (VATS, open thoracotomy) in the medical thoracoscopy or fibrinolytic therapy arm; 2. Need of additional chest tube and/or fibrinolytic therapy in the medical thoracoscopy arm due to clinical non-responsiveness; 3. Need of additional chest tube in the fibrinolytic therapy arm due to clinical non-responsiveness
Adverse events	12 week follow up period	Any adverse event (pain or bleeding)
In hospital and 30-day mortality	30 days	Death of a patient while being hospitalized or up to 30 days after
Inflammatory biomarker (CRP) from randomization (day 0), at 6 weeks and 12 weeks respectively	at randomization and at 6 and12 week follow up visit	Inflammatory biomarker measure
Total costs of each treatment modality	6 and 12 week follow up period	Total cost of each of treatment modality

Trial Locations

Locations (1)

Beth Israel Deaconess Medical Center; 🇺🇸 Boston, Massachusetts, United States