Fibrinolysis Compared to Thoracoscopy for Pleural Infection

Tulane University

Status and phase: Completed; Phase 4

Conditions: Pleural Diseases; Parapneumonic Effusion; Pleural Infection; Empyema

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

Study type: Interventional

Funder types: Other

Identifiers

NCT03468933

1070390

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 complicated 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: 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

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

Fibrinolytic therapy 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) via chest tube.

Treatment:

Drug: tissue plasminogen activator (tPA) and human recombinant deoxyribonuclease (DNase)

Medical Thoracoscopy group

Active Comparator group

Description:

Patients randomized to the Thoracoscopy group will undergo medical thoracoscopy.

Treatment:

Procedure: Medical Thoracoscopy