Fibrinolysis Compared to Thoracoscopy for Pleural Infection

Beth Israel Lahey Health

Status: Completed

Conditions: Pleural Diseases; Pleural Infection

Treatments: Other: Fibrinolytic Group; Other: Medical Thoracoscopy

Study type: Interventional

Funder types: Other

Identifiers

NCT02973139

2016P000307

Details and patient eligibility

About

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.

Full 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

Enrollment: 32 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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32 participants in 2 patient groups

Thoracoscopy group

Active Comparator group

Description:

Patients randomized to the Thoracoscopy group will undergo medical thoracoscopy.

Treatment:

Other: Medical Thoracoscopy

Fibrinolytic group

Active Comparator group

Description:

Patients randomized to the Fibrinolytic group will receive intrapleural therapy of combined tissue plasminogen activator (tPA) and human recombinant deoxyribonuclease (DNase)

Treatment:

Other: Fibrinolytic Group