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Treatment of Complicated Parapneumonic Effusion With Fibrinolytic Therapy Versus VATs Decortication

NCT03583931 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2022-01-27

Study results available
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Summary

This study aims to standardize the treatment of pleural space (parapneumonic) infections by comparing the difference in outcomes between 2 methods of treatment: early VATS (Video Assisted Thorascopic Surgery) decortication versus fibrinolytic therapy. During treatment, the patient's coagulopathy status will also be evaluated.

Conditions

  • Parapneumonic Effusion
  • Empyema, Pleural
  • Coagulopathy

Interventions

PROCEDURE

VATS Decortication

Surgical procedure to unroof all located collections of the pleural space through a chest wall incision

DRUG

Fibrinolytic Therapy

Instillation of DNAse and tPA together through patient's chest tube already in placed to break down complex fluid collection in the pleural space. DNAse and tPA are are administered together only i.e. are not mutually exclusive.

Sponsors & Collaborators

  • Denver Health and Hospital Authority

    lead OTHER

Principal Investigators

  • Fredric Pieracci, MD, MPH · Denver Health and Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-07-26
Primary Completion
2020-02-02
Completion
2020-02-02

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 NCT03583931 on ClinicalTrials.gov