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Fibrinolysis Compared to Thoracoscopy for Pleural Infection

NCT03468933 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 32

Last updated 2021-02-04

Study results available
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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.

Conditions

  • Pleural Infection
  • Empyema
  • Pleural Diseases
  • Parapneumonic Effusion

Interventions

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.

Sponsors & Collaborators

  • Tulane University

    lead OTHER

Principal Investigators

  • Fayez Kheir, MD, MSc · Tulane University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-11-01
Primary Completion
2019-12-30
Completion
2019-12-30
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03468933 on ClinicalTrials.gov