NCT02973139

Fibrinolysis Compared to Thoracoscopy for Pleural Infection

Fibrinolytic Therapy Versus Medical Thoracoscopy for Treatment of Pleural Infection: A Randomized Clinical Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 32 (actual)
• Sponsor: Beth Israel Deaconess Medical Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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 complex parapneumonic effusion (CPPE) in adults.

Detailed description

Background: Pleural infection (empyema or complex parapneumonic effusion (CPPE)) represents one of the most common clinical diagnoses encountered in clinical practice in the United States (US) It is associated with substantial morbidity and mortality despite advances in medical diagnostic and therapeutic strategies. Objective: Compare two standard of care treatments: TPA/DNase vs early medical Thoracoscopy Methods: We will conduct a prospective randomized clinical trial. We plan to enroll a total of 80 patients and randomize them to either Medical Thoracoscopy group or Fibrinolytic Therapy group. Follow-up will be daily until hospital discharge and at 6 and 12 weeks in the outpatient setting Primary Outcome: Duration of hospital stay after intervention Secondary Outcome: Failure rate of assigned treatment and adverse events Potential Outcome and Benefit: Determine best strategy for treating patients with pleural infection

Conditions

• Pleural Infection
• Pleural Diseases

Interventions

Type	Name	Description
OTHER	Medical Thoracoscopy	Medical thoracoscopy will be performed as per standard protocols.
OTHER	Fibrinolytic Group	Patients will receive intrapleural combination of TPA (10 mg) and DNAse (5 mg). Therapy will be given twice daily for a maximum of 6 doses

Timeline

• Start date: 2017-07-14
• Primary completion: 2019-11-01
• Completion: 2019-11-01
• First posted: 2016-11-25
• Last updated: 2019-12-26

Locations

1 site across 1 country: United States