Phase 4
N=5
Fibrinolytic Therapy Versus Medical Thoracoscopy
Pleural Diseases
Bottom Line
View on ClinicalTrials.gov: NCT03213834 ↗Enrolled (actual)
5
Serious AEs
0.0%
Results posted
Feb 2024
Primary outcome: Primary: Number of Hospital Days for Required to Treat Complicated Parapneumonic Effusions or Pleural Empyema. — 13; 18.5 days
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Chest thoracoscopy (Procedure); Chest fibrinolytic therapy (Procedure); tPA (Drug); DNase (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Florida
- Primary completion
- Feb 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Hospital Days for Required to Treat Complicated Parapneumonic Effusions or Pleural Empyema. |
13; 18.5 | — |
| SECONDARY Duration of Chest Tube |
13; 7 | — |
| SECONDARY Duration of Entire Hospital Stay for Complete Treatment of Pleural Infection |
13; 18.5 | — |
| SECONDARY Treatment Failure |
2; 1 | — |
| SECONDARY Number of Participants With Adverse Events |
0; 0 | — |
| SECONDARY Mortality |
0; 0 | — |
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.
Eligibility Criteria
Inclusion Criteria
- CPPE along with evidence of septated pleural effusion on pleural ultrasonography and/or chest CT scan
- empyema.
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;
- inability to tolerate procedure due to hemodynamic instability or severe hypoxemia;
- inability to correct coagulopathy;
- presence of a homogeneously echogenic effusion on pleural US27 -
Data sourced from ClinicalTrials.gov (NCT03213834). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.