Intrapleural Fibrinolytic Therapy to Enhance Chemical Pleurodesis Enhance Chemical Pleurodesis

• ClinicalTrials.gov Identifier: NCT04806373
• Recruitment Status: Completed
• First Posted: March 19, 2021
• Last Update Posted: March 13, 2024
• Sponsor: Memorial Healthcare System
• Collaborator: Genentech, Inc.
• Information provided by (Responsible Party): Memorial Healthcare System

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Pleural Effusion	Drug: Cathflo Activase; Drug: Talc Slurry Pleurodesis	Phase 4

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 27 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: single center, prospective, randomized, double-blind, placebo-controlled trial with two arms
• Masking: Triple (Participant, Care Provider, Investigator)
• Masking Description: Double blind. Pharmacist will be unblinded.
• Primary Purpose: Treatment
• Official Title: Prospective Randomized Double-Blind Controlled Trial of Intrapleural Fibrinolytic Therapy to Enhance Chemical Pleurodesis
• Actual Study Start Date: June 15, 2021
• Actual Primary Completion Date: December 14, 2023
• Actual Study Completion Date: December 14, 2023

Arms and Interventions

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 Name: 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: Cathflo Activase; Cathflo Activase 4mg in 50ml normal saline given through chest pleural catheter; Drug: Talc Slurry Pleurodesis; Talc, 5 gm in 50 ml Normal Saline given through chest pleural catheter; Other Name: TSP

Outcome Measures

Primary Outcome Measures :

1. Positive Change in successful pleurodesis rates [ Time Frame: 3-5 days ]
   To determine if intrapleural administration of Talc slurry with cathflo activase will improve successful pleurodesis rates compared to talc slurry alone.

Secondary Outcome Measures :

1. Incidence of Complications [ Time Frame: 3 months ]
   To determine if giving cathflo activase with TSP is associated with a higher incidence of complications compared to TSP with placebo.

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

United States, Florida

Memorial Healthcare System

Hollywood, Florida, United States, 33021

Sponsors and Collaborators

Memorial Healthcare System

Genentech, Inc.

Investigators

• Principal Investigator: Mark Block, MD; Chief, Thoracic Surgery

More Information

• Responsible Party: Memorial Healthcare System
• ClinicalTrials.gov Identifier: NCT04806373
• Other Study ID Numbers: MHS 2020.144; ML42028 ( Other Identifier: Genentech )
• First Posted: March 19, 2021
• Last Update Posted: March 13, 2024
• Last Verified: March 2024

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No
• Plan Description: Single center study

• 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

Additional relevant MeSH terms:

Pleural Effusion; Pleural Diseases; Respiratory Tract Diseases; Tissue Plasminogen Activator; Fibrinolytic Agents; Fibrin Modulating Agents; Molecular Mechanisms of Pharmacological Action