Intrapleural Fibrinolytic Therapy to Enhance Chemical Pleurodesis Enhance Chemical Pleurodesis

NCT04806373 | Completed Phase 4 Results DMC FDA Drug

• 2 other identifiers: MHS 2020.144ML42028
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 1

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.

Conditions

Pleural Effusion

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (9)

• Pleural Drainage Volume (mL) After Pleurodesis

  3 days

• Dyspnea on Day 3 After Pleurodesis

  3 days

• Pain Score

  3 days

• Chest Tube Size

  day 1

• Time to Chest Tube Removal

  Days from pleurodesis to chest tube removal

Study Arms (2)

Talc Slurry Pleurodesis (TSP) plus placebo

PLACEBO COMPARATOR

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 Slurry Pleurodesis (TSP) plus Cathflo Activase

EXPERIMENTAL

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; Drug: Talc Slurry Pleurodesis

Interventions

Cathflo Activase DRUG

Cathflo Activase 4mg in 50ml normal saline given through chest pleural catheter

Talc Slurry Pleurodesis (TSP) plus Cathflo Activase

Talc Slurry Pleurodesis DRUG

Talc, 5 gm in 50 ml Normal Saline given through chest pleural catheter

Also known as: TSP

Talc Slurry Pleurodesis (TSP) plus Cathflo Activase; Talc Slurry Pleurodesis (TSP) plus placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Memorial Healthcare System: lead
• Genentech, Inc.: collaborator

Study Sites (1)

Memorial Healthcare System

Hollywood, Florida, 33021, United States

Location

MeSH Terms

Conditions

Pleural Effusion

Interventions

Tissue Plasminogen Activator

Condition Hierarchy (Ancestors)

Pleural Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Serine Endopeptidases; Endopeptidases; Peptide Hydrolases; Hydrolases; Enzymes; Enzymes and Coenzymes; Serine Proteases; Plasminogen Activators; Blood Coagulation Factors; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Biological Factors

Results Point of Contact

• Title: Mark Block, Chief, Division of Thoracic Surgery
• Organization: Memorial Healthcare System

mblock@mhs.net

9542651125

Study Officials

• Mark Block, MD

  Chief, Thoracic Surgery

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: Double blind. Pharmacist will be unblinded.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: single center, prospective, randomized, double-blind, placebo-controlled trial with two arms

Study Record Dates

• First Submitted: March 16, 2021
• First Posted: March 19, 2021
• Study Start: June 15, 2021
• Primary Completion: December 14, 2023
• Study Completion: December 14, 2023
• Last Updated: June 8, 2025
• Results First Posted: December 11, 2024

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)