N/A N=10 Randomized Treatment

Treatment of Complicated Parapneumonic Effusion With Fibrinolytic Therapy Versus VATs Decortication

Parapneumonic Effusion · Empyema, Pleural · Coagulopathy

Bottom Line

View on ClinicalTrials.gov: NCT03583931 ↗

Enrolled (actual)

Serious AEs

20.0%

Results posted

Jan 2022

Primary outcome: Primary: Hospital Length of Stay — 12.4; 8.4 days

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: VATS Decortication (Procedure); Fibrinolytic Therapy (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Denver Health and Hospital Authority
Primary completion: Feb 2020

Outcome Measures

Outcome	Result	p-value
PRIMARY Hospital Length of Stay	12.4; 8.4	—
SECONDARY ICU Free Days	22.4; 20	0.61
SECONDARY Chest Tube Days	7.4; 8.2	0.84
SECONDARY Cost of Admission and Treatment	—	—
SECONDARY Pain Score	3.6; 4.6	—
SECONDARY Chest Tube Drainage	60.1; 713.2	—
SECONDARY Incentive Spirometry	—	—
SECONDARY Supplemental Oxygen Days	17.8; 9.6	0.48
SECONDARY Fever Days	4.8; 0.8	0.25
SECONDARY Days of Antibiotics	17; 25.6	0.45
SECONDARY Elevated White Blood Count Days	5.6; 6	0.87
SECONDARY Changed in Coagulopathic Status	—	—

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.

Eligibility Criteria

Inclusion Criteria

18 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

Exclusion Criteria

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03583931). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.