NCT03468933

Fibrinolysis Compared to Thoracoscopy for Pleural Infection

Intrapleural Tissue Plasminogen Activator and Deoxyribonuclease Therapy Versus Early Medical Thoracoscopy for Treatment of Pleural Infection: A Randomized Clinical Trial

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 32 (actual)
• Sponsor: Tulane University · 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 complicated 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: Investigators will conduct a prospective randomized clinical trial. Plan is to enroll total of 32 patients and randomize those patients 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 Potential Outcome and Benefit: Determine best strategy for treating patients with pleural infection

Conditions

• Pleural Infection
• Empyema
• Pleural Diseases
• Parapneumonic Effusion

Interventions

Type	Name	Description
DRUG	tissue plasminogen activator (tPA) and human recombinant deoxyribonuclease (DNase)	Patients will receive intrapleural combination of TPA (10 mg) and DNAse (5 mg). Therapy will be given twice daily for a maximum of 6 dose
PROCEDURE	Medical Thoracoscopy	Medical thoracoscopy will be performed as per standard protocols.

Timeline

• Start date: 2017-11-01
• Primary completion: 2019-12-30
• Completion: 2019-12-30
• First posted: 2018-03-19
• Last updated: 2021-02-04
• Results posted: 2021-02-04

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study