Fibrinolytic Therapy Versus Medical Thoracoscopy

University of Florida

Status and phase: Completed; Phase 4

Conditions: Pleural Diseases

Treatments: Procedure: Chest fibrinolytic therapy; Procedure: Chest thoracoscopy; Drug: tPA; Drug: DNase

Study type: Interventional

Funder types: Other

Identifiers

NCT03213834

IRB201700012

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 complicated pleural infections in adults as defined as complicated parapneumonic effusions or pleural empyema.

Full description

Pleural infection (empyema or complex parapneumonic effusion [CPPE]) represents one of the common clinical diagnoses encountered in clinical practice in the United States (US) and worldwide. The incidence of pleural infection continues to rise with an annual incidence of approximately 65,000 in the US and United Kingdom (UK). It is associated with substantial morbidity and mortality as well as increased hospital costs despite advances in medical diagnostic and therapeutic strategies. The overall mortality of pleural infection approaches 20% and it is above 30% in elderly patients over 65 years and immunocompromised patients.

Treatment of CPPE or empyema requires antibiotics and drainage of the pleural cavity.3 However, in about 30% of cases, it is difficult to remove the fluid due to loculations, septations and increased viscosity of the pleural fluid, and around 20% will need surgical intervention to adequately treat the pleural infection.

Specific Aim 1:

To compare the efficacy of early medical thoracoscopy versus fibrinolytic therapy (tPA/DNase) in patients with complicated parapneumonic effusions or pleural empyema.

CPPE is defined as non-purulent effusion in a patient with clinical evidence of infection such as fever and/or elevated blood leukocyte count and/or elevated CRP, with pleural fluid pH ≤ 7.2 (measured by blood-gas analyzer), or pleural fluid glucose < 60 mg/dl or pleural fluid LDH >1000 IU/L26. Empyema is defined as pus within the pleural space and/or presence of bacteria on pleural fluid Gram stain or culture.

For patients to be considered for the trial they need to fulfill one of the following criteria: 1) CPPE along with evidence of septated pleural effusion on pleural ultrasonography and/or chest CT scan or 2) empyema.

Enrollment: 5 patients

Sex: All

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. CPPE along with evidence of septated pleural effusion on pleural ultrasonography and/or chest CT scan
2. empyema.

Exclusion criteria

1. age <18 years;
2. Pregnancy
3. inability to give informed written consent;
4. previous thoracic surgery or thrombolytic therapy for pleural infection;
5. medical thoracoscopy cannot be performed within 48 hours;
6. inability to tolerate procedure due to hemodynamic instability or severe hypoxemia;
7. inability to correct coagulopathy;
8. presence of a homogeneously echogenic effusion on pleural US27 -

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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5 participants in 2 patient groups

Thoracoscopy Arm

Active Comparator group

Description:

Consisting of chest thoracoscopy

Treatment:

Procedure: Chest thoracoscopy

Fibrinolytic Therapy Arm

Active Comparator group

Description:

Consisting of chest fibrinolytic therapy

Treatment:

Drug: DNase

Drug: tPA

Procedure: Chest fibrinolytic therapy