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Intrapleural Fibrinolytic Therapy to Enhance Chemical Pleurodesis Enhance Chemical Pleurodesis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04806373
Recruitment Status : Recruiting
First Posted : March 19, 2021
Last Update Posted : October 18, 2023
Sponsor:
Collaborator:
Genentech, Inc.
Information provided by (Responsible Party):
Memorial Healthcare System

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 136 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
Estimated Primary Completion Date : June 1, 2024
Estimated Study Completion Date : December 1, 2024

Resource links provided by the National Library of Medicine

Drug Information available for: Alteplase

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




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.



Information from the National Library of Medicine

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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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04806373


Contacts
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Contact: Candice Sareli, MD 9542651847 csareli@mhs.net
Contact: Nithya Sundararaman 9542651846 nsundararaman@mhs.net

Locations
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United States, Florida
Memorial Healthcare System Recruiting
Hollywood, Florida, United States, 33021
Contact: Candice Sareli, MD    954-265-1847    csareli@mhs.net   
Contact: Jianli Niu, MD, PhD    954-265-6653    jniu@mhs.net   
Sponsors and Collaborators
Memorial Healthcare System
Genentech, Inc.
Investigators
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Principal Investigator: Mark Block, MD Chief, Thoracic Surgery
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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    Key Record Dates
Last Update Posted: October 18, 2023
Last Verified: October 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Single center study

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