Fibrinolysis Compared to Thoracoscopy for Pleural Infection

Pleural Diseases Clinical Trial

Official title:

Fibrinolytic Therapy Versus Medical Thoracoscopy for Treatment of Pleural Infection: A Randomized Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02973139
• Other study ID #: 2016P000307
• Status: Completed
• Phase: N/A
• Start date: July 14, 2017
• Est. completion date: November 1, 2019

Study information

• Verified date: December 2019
• Source: Beth Israel Deaconess Medical Center
• 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 complex 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: 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: November 1, 2019
• Est. primary completion date: November 1, 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
• Infection
• Pleural Diseases
• Pleural Infection

Intervention

Other:
• Medical Thoracoscopy
Medical thoracoscopy will be performed as per standard protocols.
• Fibrinolytic Group
Patients will receive intrapleural combination of TPA (10 mg) and DNAse (5 mg). Therapy will be given twice daily for a maximum of 6 doses

Locations

Country	Name	City	State
United States	Beth Israel Deaconess Medical Center	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Beth Israel Deaconess Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Duration of hospital stay after intervention	Number of days hospitalized	12 week follow up period
Secondary	Number of days with chest drainage	Number of days with chest drainage	12 week follow up period
Secondary	Total length of hospital stay	Total days spent in the hospital	12 week follow up period
Secondary	Failure rate of assigned treatment necessitating intervention	defined as any of the following: Surgical intervention (VATS, open thoracotomy) in the medical thoracoscopy or fibrinolytic therapy arm; Need of additional chest tube and/or fibrinolytic therapy in the medical thoracoscopy arm due to clinical non-responsiveness; Need of additional chest tube in the fibrinolytic therapy arm due to clinical non-responsiveness	12 week follow up period
Secondary	Adverse events	Any adverse event (pain or 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
Secondary	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	Pleural fluid volume measured with CT scan	12 week follow up period
Secondary	Inflammatory biomarker (CRP) from randomization (day 0), at 6 weeks and 12 weeks respectively	Inflammatory biomarker measure	at randomization and at 6 and12 week follow up visit
Secondary	Total costs of each treatment modality	Total cost of each of treatment modality	6 and 12 week follow up period