CompletedPhase 4

Fibrinolytic Therapy Versus Medical Thoracoscopy

United States5 participantsStarted 2017-09-14

Plain-language 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.

Who can participate

Age range18 Years – 90 Years

SexALL

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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 -

What they're measuring

Number of Hospital Days for Required to Treat Complicated Parapneumonic Effusions or Pleural Empyema.

Timeframe: 30 days starting on day of admission

Trial details

NCT IDNCT03213834

SponsorUniversity of Florida

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2020-02-04

Results submitted2021-11-09

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