Fibrinolytic Therapy Versus Medical Thoracoscopy

Phase 4

Completed

• Conditions: Pleural Diseases
• Interventions: Procedure: Chest thoracoscopy; Procedure: Chest fibrinolytic therapy; Drug: tPA; Drug: DNase

• Registration Number: NCT03213834
• Lead Sponsor: University of Florida

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

Detailed 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.

Study Timeline

• Study First Submitted: 2017-07-07
• Study First Submitted QC: 2017-07-07
• Study First Posted: 2017-07-11
• Study Start: 2017-09-14
• Primary Completion: 2020-02-04
• Study Completion: 2020-02-04
• Results First Submitted: 2021-11-09
• Status Verified: 2023-09
• Results First Submitted QC: 2024-02-15
• Last Update Submitted: 2024-02-15
• Results First Posted: 2024-02-20
• Last Update Posted: 2024-02-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 5

Inclusion Criteria

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

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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 -

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Thoracoscopy Arm	Chest thoracoscopy	Consisting of chest thoracoscopy
Fibrinolytic Therapy Arm	Chest fibrinolytic therapy	Consisting of chest fibrinolytic therapy
Fibrinolytic Therapy Arm	DNase	Consisting of chest fibrinolytic therapy
Fibrinolytic Therapy Arm	tPA	Consisting of chest fibrinolytic therapy

Primary Outcome Measures

Name	Time	Method
Number of Hospital Days for Required to Treat Complicated Parapneumonic Effusions or Pleural Empyema.	30 days starting on day of admission	Time between initiation of treatment and hospital discharge

Secondary Outcome Measures

Name	Time	Method
Treatment Failure	30 days starting on day of admission	Following intervention, if patient requires (1) surgical intervention (VATS, open thoracotomy), (2) an additional chest tube, or (3) a repeat procedure
Number of Participants With Adverse Events	30 days starting on day of admission	Number of participants who experienced documented adverse events during their hospital stays
Duration of Entire Hospital Stay for Complete Treatment of Pleural Infection	30 days starting on day of admission	Number of days patient registered as in-house for treatment of pleural infection
Mortality	30 days starting on day of admission	In hospital and 30 day mortality measures
Duration of Chest Tube	30 days starting on day of admission	The number of days, during the hospital admission, where the patient demonstrated chest tube drainage

Trial Locations

Locations (1)

University of Florida; 🇺🇸 Gainesville, Florida, United States