Phase 4
N=32
Fibrinolysis Compared to Thoracoscopy for Pleural Infection
Pleural Infection · Empyema · Pleural Diseases · Parapneumonic Effusion
Bottom Line
View on ClinicalTrials.gov: NCT03468933 ↗Enrolled (actual)
32
Serious AEs
0.0%
Results posted
Feb 2021
Primary outcome: Primary: Duration of Hospital Stay After Intervention — 4; 2 days
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- tissue plasminogen activator (tPA) and human recombinant deoxyribonuclease (DNase) (Drug); Medical Thoracoscopy (Procedure)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Tulane University
- Primary completion
- Dec 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Duration of Hospital Stay After Intervention |
4; 2 | — |
| SECONDARY Total Length of Hospital Stay |
6; 3.5 | — |
| SECONDARY Number of Participants Necessitating Intervention After the Assigned Treatment |
3; 4 | — |
| SECONDARY Adverse Events |
1; 1 | — |
| SECONDARY In Hospital and 30-day Mortality |
0; 1 | — |
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 empyema or complicated parapneumonic effusion (CPPE) in adults.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT03468933). 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.