Treatment of Complicated Parapneumonic Effusion With Fibrinolytic Therapy Versus VATs Decortication
Early Intervention for Complicated Parapneumonic Effusion: Randomized Controlled Trial for Fibrinolytic Therapy Versus VATs Decortication
1 other identifier
interventional
10
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Jul 2018
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 11, 2018
CompletedFirst Posted
Study publicly available on registry
July 12, 2018
CompletedStudy Start
First participant enrolled
July 26, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 2, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
February 2, 2020
CompletedResults Posted
Study results publicly available
January 27, 2022
CompletedJanuary 27, 2022
November 1, 2021
1.5 years
May 11, 2018
August 2, 2021
November 19, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Hospital Length of Stay
How long the patient remains admitted in the hospital during their index hospitalization
From patient's admission to hospital to their discharge, (excluding extended stay due to social work reasons) up to 28 days or discharge, which ever comes first.
Secondary Outcomes (11)
ICU Free Days
From admission to discharge, or for 28 days, whichever comes first.
Chest Tube Days
From admission to discharge, or for 28 days, whichever comes first.
Cost of Admission and Treatment
From admission to discharge, or for 28 days, whichever comes first.
Pain Score
From admission to discharge, or for 28 days, whichever comes first.
Chest Tube Drainage
From admission to discharge, or for 28 days, whichever comes first.
- +6 more secondary outcomes
Study Arms (2)
Operative VATS decortication
ACTIVE COMPARATOROperative group that will undergo early VATS decortication of complicated parapneumonic effusion/empyema
Non-operative Fibrinolytic Therapy
ACTIVE COMPARATORNon-operative group that will undergo instillation of the drugs DNAse and tPA (tissue plasminogen activator) together i.e. 5mg DNAse and 10mg tPA twice a day for up to six doses, through chest tube as treatment of the patient's complicated parapneumonic effusion/empyema. Fibrinolytic therapy = DNAse + tPA; these medications are not mutually exclusive.
Interventions
Surgical procedure to unroof all located collections of the pleural space through a chest wall incision
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.
Eligibility Criteria
You may qualify if:
- years old and older
- Admitted with pleural effusion that undergoes thoracentesis by medical/pulmonary service
- Pleural fluid pH \<7.3
- SICU placed chest tube
- Subsequent transfer to SICU
You may not qualify if:
- Existing malignancy
- Malignant cells from initial pleural fluid sample
- End stage liver disease (Child's B or greater)
- Coagulopathy
- Unable to tolerate surgical procedure
- Frank purulent drainage (needs OR regardless)
- Recent surgery of abdomen or thorax precluding the use of tPA
- Baseline neurologic impairment requiring a proxy for consent
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Denver Health
Denver, Colorado, 80204, United States
Related Publications (1)
Barrett CD, Moore PK, Moore EE, Moore HB, Chandler JG, Siddiqui H, Maginot ER, Sauaia A, Perez-Calatayud AA, Buesing K, Wang J, Davila-Chapa C, Hershberger D, Douglas I, Pieracci FM, Yaffe MB. Neutrophil-Mediated Inflammatory Plasminogen Degradation, Rather Than High Plasminogen-Activator Inhibitor-1, May Underly Failures and Inefficiencies of Intrapleural Fibrinolysis. Chest. 2025 Jan;167(1):67-75. doi: 10.1016/j.chest.2024.04.005. Epub 2024 May 6.
PMID: 38710463DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Limitations and Caveats
Potential limitations to this study include a small sample size.
Results Point of Contact
- Title
- Dr Fredric Pieracci
- Organization
- Denver Health and Hospital Authority
Study Officials
- PRINCIPAL INVESTIGATOR
Fredric Pieracci, MD, MPH
Denver Health and Hospital
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 11, 2018
First Posted
July 12, 2018
Study Start
July 26, 2018
Primary Completion
February 2, 2020
Study Completion
February 2, 2020
Last Updated
January 27, 2022
Results First Posted
January 27, 2022
Record last verified: 2021-11