Intrapleural Fibrinolytic Therapy to Enhance Chemical Pleurodesis Enhance Chemical Pleurodesis

Sponsor
Memorial Healthcare System (Other)
Overall Status
Recruiting
CT.gov ID
NCT04806373
Collaborator
Genentech, Inc. (Industry)
136
1
2
29.5
4.6

Study Details

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
  • 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
Anticipated Enrollment :
136 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
single center, prospective, randomized, double-blind, placebo-controlled trial with two armssingle 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 :
Jun 15, 2021
Anticipated Primary Completion Date :
Jun 1, 2023
Anticipated Study Completion Date :
Dec 1, 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 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: 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 Names:
  • TSP
  • Outcome Measures

    Primary Outcome Measures

    1. Positive Change in successful pleurodesis rates [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 [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

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Site City State Country Postal Code
    1 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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Memorial Healthcare System
    ClinicalTrials.gov Identifier:
    NCT04806373
    Other Study ID Numbers:
    • MHS 2020.144
    • ML42028
    First Posted:
    Mar 19, 2021
    Last Update Posted:
    Aug 24, 2022
    Last Verified:
    Aug 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    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:

    Study Results

    No Results Posted as of Aug 24, 2022