Clinical trial NCT04806373: Intrapleural Fibrinolytic Therapy to Enhance Chemical Pleurodesis Enhance Chemical Pleurodesis
Official title: Prospective Randomized Double-Blind Controlled Trial of Intrapleural Fibrinolytic Therapy to Enhance Chemical Pleurodesis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Pleural Effusion
Lead sponsor: Memorial Healthcare System
Sponsor class: OTHER
Collaborators: name: Genentech, Inc.
First posted: 2021-03-19
Enrollment: 27
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: single center, prospective, randomized, double-blind, placebo-controlled trial with two arms
Primary purpose: TREATMENT

Brief 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

1. Age \> 18 years
2. Symptomatic pleural effusion requiring intervention
3. Expected survival \> 3 months
4. Written informed consent to trial participation

Exclusion Criteria:

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

Primary outcomes:
measure: Chest X-ray Results on Day 3 After Pleurodesis
timeFrame: 3-5 days
Secondary outcomes:
measure: Pleural Drainage Volume (mL) After Pleurodesis
timeFrame: 3 days
measure: Dyspnea on Day 3 After Pleurodesis
timeFrame: 3 days
measure: Pain Score
timeFrame: 3 days
measure: Chest Tube Size
timeFrame: day 1
measure: Time to Chest Tube Removal
timeFrame: Days from pleurodesis to chest tube removal
measure: Length of Stay
timeFrame: days
measure: Radiographically Satisfactory Pleurodesis
timeFrame: days
measure: Time to Achieve Radiographically Satisfactory Pleurodesis
timeFrame: days
measure: 30 Day Mortality
timeFrame: 30 days from pleurodesis
Other outcomes:
Locations:
city: Hollywood
country: United States
facility: Memorial Healthcare System
state: Florida
Study officials:
affiliation: Chief, Thoracic Surgery
name: Mark Block, MD
role: PRINCIPAL_INVESTIGATOR
References: