NCT03583931

Treatment of Complicated Parapneumonic Effusion With Fibrinolytic Therapy Versus VATs Decortication

Completed NA Results posted Last updated 27 January 2022

What this trial tests

NA trial testing VATS Decortication in Parapneumonic Effusion in 10 participants. Completed in 2 February 2020.

Timeline

26 July 2018

Primary endpoint
2 February 2020

2 February 2020

Quick facts

Lead sponsor	Denver Health and Hospital Authority
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	10
Start date	26 July 2018
Primary completion	2 February 2020
Estimated completion	2 February 2020
Sites	1 location across United States

Drugs / interventions tested

• VATS Decortication
• Fibrinolytic Therapy — full drug profile →

Conditions studied

• Parapneumonic Effusion — all drugs for Parapneumonic Effusion →
• Empyema, Pleural — all drugs for Empyema, Pleural →
• Coagulopathy — all drugs for Coagulopathy →

Sponsor

Denver Health and Hospital Authority

Who can join

18 and older, any sex, with Parapneumonic Effusion or Empyema, Pleural. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Hospital Length of Stay Primary · 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.

How long the patient remains admitted in the hospital during their index hospitalization

Group	Value	95% CI
Operative VATS Decortication	12.4	± 16.7
Non-operative Fibrinolytic Therapy	8.4	± 4.1

ICU Free Days Secondary · From admission to discharge, or for 28 days, whichever comes first.

Admission days during index hospitalization that are of a lower acuity of care than intensive care

Group	Value	95% CI
Operative VATS Decortication	22.4	± 8
Non-operative Fibrinolytic Therapy	20	± 6.2

Chest Tube Days Secondary · From admission to discharge, or for 28 days, whichever comes first.

Days with chest tube in place after intervention

Group	Value	95% CI
Operative VATS Decortication	7.4	± 8.2
Non-operative Fibrinolytic Therapy	8.2	± 2.4

Pain Score Secondary · From admission to discharge, or for 28 days, whichever comes first.

What the patient's level of pain is from 0 to 10; zero being no pain, 10 being the worst pain imaginable. score is categorical 0,1,2,3,4,5,6,7,8,9 or 10.

Group	Value	95% CI
Operative VATS Decortication	3.6	± 1
Non-operative Fibrinolytic Therapy	4.6	± 2

Chest Tube Drainage Secondary · From admission to discharge, or for 28 days, whichever comes first.

The amount and character of the drainage from the chest tube after intervention

Group	Value	95% CI
Operative VATS Decortication	60.1	± 12.3
Non-operative Fibrinolytic Therapy	713.2	± 180.3

Supplemental Oxygen Days Secondary · From admission to discharge, or for 28 days, whichever comes first.

The amount of time the patient needs to warn off any supplemental oxygen

Group	Value	95% CI
Operative VATS Decortication	17.8	± 24.5
Non-operative Fibrinolytic Therapy	9.6	± 2.3

Fever Days Secondary · From admission to discharge, or for 28 days, whichever comes first.

The amount of days it takes to resolve fever (temp \>100.4)

Group	Value	95% CI
Operative VATS Decortication	4.8	± 5.3
Non-operative Fibrinolytic Therapy	0.8	± 1.1

Days of Antibiotics Secondary · From admission to discharge, or for 28 days, whichever comes first.

The number of days antibiotics are required after intervention

Group	Value	95% CI
Operative VATS Decortication	17	± 9.3
Non-operative Fibrinolytic Therapy	25.6	± 24.6

Elevated White Blood Count Days Secondary · From admission to discharge, or for 28 days, whichever comes first.

The amount of days it takes to resolve a leukocytosis

Group	Value	95% CI
Operative VATS Decortication	5.6	± 4
Non-operative Fibrinolytic Therapy	6	± 3.6

Adverse events — posted to ClinicalTrials.gov

Time frame: Through study completion, average of 1 year, which was the length of time participants were followed.. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Operative VATS Decortication

Serious: 0/5 (0%)

Deaths: 0/5

Non-operative Fibrinolytic Therapy

Serious: 2/5 (40%)

Deaths: 1/5

Serious adverse events (3 terms)

Reaction	System	Operative VATS Decortication	Non-operative Fibrinolytic…
altered mental state	General disorders	—	—
Pneumothorax	Respiratory, thoracic and mediastinal disorders	—	—
unplanned readmission	Respiratory, thoracic and mediastinal disorders	—	—

Other adverse events (1 terms — click to expand)

Reaction	System	Operative VATS Decortication	Non-operative Fibrinolytic…
additional CT	Respiratory, thoracic and mediastinal disorders	—	—

Most-reported serious reactions: altered mental state, Pneumothorax, unplanned readmission.

Data from ClinicalTrials.gov NCT03583931 adverse events section.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Neutrophil-Mediated Inflammatory Plasminogen Degradation, Rather Than High Plasminogen-Activator Inhibitor-1, May Underly Failures and Inefficiencies of Intrapleural Fibrinolysis.
   Barrett CD, Moore PK, Moore EE, Moore HB, et al · · 2025 · cited 11× · PMID 38710463 · DOI 10.1016/j.chest.2024.04.005