Intrapleural Fibrinolytic Therapy to Enhance Chemical Pleurodesis Enhance Chemical Pleurodesis

Prospective Randomized Double-Blind Controlled Trial of Intrapleural Fibrinolytic Therapy to Enhance Chemical Pleurodesis

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.

Study Overview

• Status: Completed
• Conditions: Pleural Effusion
• Intervention / Treatment: Drug: Talc Slurry Pleurodesis; Drug: Cathflo Activase

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.

• Study Type: Interventional
• Enrollment (Actual): 27
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Florida
    • Hollywood, Florida, United States, 33021
      • Memorial Healthcare System

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Talc Slurry Pleurodesis (TSP) plus placebo; Patients who sign informed consent may be randomized to receive TSP alone (talc, 5 gm in 50 ml NS) with placebo (50 ml Normal saline (NS)) through the chest pleural catheter.	Drug: Talc Slurry Pleurodesis; Talc, 5 gm in 50 ml Normal Saline given through chest pleural catheter; Other Names: TSP
Experimental: Talc Slurry Pleurodesis (TSP) plus Cathflo Activase; Patients who sign informed consent may be randomized to receive TSP (Talc, 5mg in 50ml Normal saline (NS)) with cathflo activase (4 mg in 50 ml NS) through the chest pleural catheter	Drug: Talc Slurry Pleurodesis; Talc, 5 gm in 50 ml Normal Saline given through chest pleural catheter; Other Names: TSP; Drug: Cathflo Activase; Cathflo Activase 4mg in 50ml normal saline given through chest pleural catheter

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Chest X-ray Results on Day 3 After Pleurodesis	Evaluate whether the chest x-ray is better (+1), the same (0), or worse (-1) than it was on the day of pleurodesis	3-5 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pleural Drainage Volume (mL) After Pleurodesis	Total volume of drainage on days 1-3 after pleurodesis	3 days
Dyspnea on Day 3 After Pleurodesis	Borg dyspnea scale complete by patient on day 3 after pleurodesis, on a scale of 0 to 10, with 10 being worst.	3 days
Pain Score	Visual analog scale for self-reported level of pain at three days after pleurodesis, from 0 to 100 with 100 being worst pain.	3 days
Chest Tube Size	Size of the chest tube used for pleural fluid drainage and talc slurry pleurodesis	day 1
Time to Chest Tube Removal	Number of days from pleurodesis to removal of the last chest tube	Days from pleurodesis to chest tube removal
Length of Stay	Total duration of hospital stay from admission to discharge, including time before pleurodesis	days
30 Day Mortality	Number of patients who died within 30 days of pleurodesis	30 days from pleurodesis
Radiographically Satisfactory Pleurodesis	Number (proportion) of patients who achieved daily chest tube drainage of less than 100 cc/24 hours, with the chest x-ray showing no evidence of accumulation of pleural fluid since pleurodesis.	days
Time to Achieve Radiographically Satisfactory Pleurodesis	Days from pleurodesis to the point at which pleurodesis is deemed successful and complete	days

Collaborators and Investigators

• Sponsor: Memorial Healthcare System
• Collaborators: Genentech, Inc.
• Investigators: Principal Investigator: Mark Block, MD, Chief, Thoracic Surgery

Study record dates

Study Major Dates

• Study Start (Actual): June 15, 2021
• Primary Completion (Actual): December 14, 2023
• Study Completion (Actual): December 14, 2023

Study Registration Dates

• First Submitted: March 16, 2021
• First Submitted That Met QC Criteria: March 16, 2021
• First Posted (Actual): March 19, 2021

Study Record Updates

• Last Update Posted (Actual): June 8, 2025
• Last Update Submitted That Met QC Criteria: May 22, 2025
• Last Verified: May 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Pleural Diseases; Pleural Effusion; Molecular Mechanisms of Pharmacological Action; Fibrin Modulating Agents; Fibrinolytic Agents; Tissue Plasminogen Activator
• Other Study ID Numbers: MHS 2020.144; ML42028 (Other Identifier: Genentech)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Single center study

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No