Phase 4 N=27 Randomized Triple-blind Treatment

Intrapleural Fibrinolytic Therapy to Enhance Chemical Pleurodesis Enhance Chemical Pleurodesis

Pleural Effusion

Bottom Line

View on ClinicalTrials.gov: NCT04806373 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Dec 2024

Primary outcome: Primary: Chest X-ray Results on Day 3 After Pleurodesis — 5; 6; 5; 8 Participants — p=0.863

Study Design & Population

Study type: Interventional
Phase: Phase 4
Interventions: Cathflo Activase (Drug); Talc Slurry Pleurodesis (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Memorial Healthcare System
Primary completion: Dec 2023

Outcome Measures

Outcome	Result	p-value
PRIMARY Chest X-ray Results on Day 3 After Pleurodesis	5; 6; 5; 8; 2; 1	0.863
SECONDARY Pleural Drainage Volume (mL) After Pleurodesis	125; 427.5; 39; 150; 45; 100	0.005 sig
SECONDARY Dyspnea on Day 3 After Pleurodesis	1; 1	0.891
SECONDARY Pain Score	10; 10	0.899
SECONDARY Chest Tube Size	4; 4; 4; 4; 2; 2	0.809
SECONDARY Time to Chest Tube Removal	7; 9	0.946
SECONDARY Length of Stay	10; 11	0.808
SECONDARY Radiographically Satisfactory Pleurodesis	8; 12	0.662
SECONDARY Time to Achieve Radiographically Satisfactory Pleurodesis	5.75; 4.83	0.714
SECONDARY 30 Day Mortality	4; 5	1.0

Summary

Prospective Randomized Double-Blind Controlled Trial of Intrapleural Fibrinolytic Therapy to Enhance Chemical Pleurodesis versus Standard of care Talc therapy in patients with recurrent pleural effusion.

Eligibility Criteria

Inclusion Criteria

Age > 18 years
Symptomatic pleural effusion requiring intervention
Expected survival > 3 months
Written informed consent to trial participation

Exclusion Criteria

Females who are pregnant or lactating
Inability to obtain consent from the patient or patient's designated representative.
Inability of the patient to comply with the protocol.
Previously documented adverse reaction to talc or cathflo activase.
Oral or intravenous steroid therapy

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Data sourced from ClinicalTrials.gov (NCT04806373). 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.