Intrapleural Fibrinolytic Therapy to Enhance Chemical Pleurodesis Enhance Chemical Pleurodesis

  • End date
    Dec 1, 2023
  • participants needed
  • sponsor
    Memorial Healthcare System
Updated on 4 October 2022


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.


This protocol describes a prospective, randomized, double-blind controlled trial comparing TSP alone to the combination of TSP with cathflo activase for achieving optimal results with pleurodesis for recurrent pleural effusion. Patients who sign informed consent will be randomly assigned to receive either TSP alone (talc, 5 gm in 50 ml NS) with placebo (50 ml NS) or TSP with cathflo activase (4 mg in 50 ml NS) through the chest pleural catheter. Follow-up lasts for three months. The primary outcome is achievement of a "Radiographically Satisfactory Pleurodesis" (RSP) by day three post-procedure, defined as chest tube drainage of less than 100cc over 24 hours and a chest x-ray showing similar or less pleural space opacification than on the day TSP was performed (baseline, day 0). Secondary outcomes include the proportion of patients who achieve RSP, time needed to achieve RSP, duration of chest tube drainage, length of hospital stay after initiation of TSP, proportion of patients requiring repeat TSP, change in serum hemoglobin during therapy, objective assessments of pain and dyspnea, and potential complications. This study will recruit 136 patients, with an interim analyses for efficacy after 50 patients, and aims to help develop the future standard for management of patients requiring pleurodesis for their symptomatic pleural effusion.

Condition Pleural Effusion
Treatment Cathflo Activase, Talc Slurry Pleurodesis
Clinical Study IdentifierNCT04806373
SponsorMemorial Healthcare System
Last Modified on4 October 2022


Yes No Not Sure

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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