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

Tracking Information

• First Submitted Date: March 16, 2021
• First Posted Date: March 19, 2021
• Last Update Posted Date: March 13, 2024
• Actual Study Start Date: June 15, 2021
• Actual Primary Completion Date: December 14, 2023 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: August 30, 2021)

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.

Original Primary Outcome Measures (submitted: March 16, 2021)

Improvement of 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.

Current Secondary Outcome Measures (submitted: March 16, 2021)

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.

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Intrapleural Fibrinolytic Therapy to Enhance Chemical Pleurodesis Enhance Chemical Pleurodesis
• Official Title: Prospective Randomized Double-Blind Controlled Trial of Intrapleural Fibrinolytic Therapy to Enhance Chemical Pleurodesis
• 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.
• 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
• Study Phase: Phase 4

Study Design

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

• Condition: Pleural Effusion

Intervention

• 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

Study Arms

• 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.
  Intervention: Drug: Talc Slurry Pleurodesis
• 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
  Interventions:

  • Drug: Cathflo Activase
  • Drug: Talc Slurry Pleurodesis

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: March 12, 2024): 27
• Original Estimated Enrollment (submitted: March 16, 2021): 136
• Actual Study Completion Date: December 14, 2023
• Actual Primary Completion Date: December 14, 2023 (Final data collection date for primary outcome measure)

Eligibility 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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT04806373
• Other Study ID Numbers: MHS 2020.144; ML42028 ( Other Identifier: Genentech )
• Has Data Monitoring Committee: Yes

U.S. FDA-regulated Product

• 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

IPD Sharing Statement

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

• Current Responsible Party: Memorial Healthcare System
• Original Responsible Party: Same as current
• Current Study Sponsor: Memorial Healthcare System
• Original Study Sponsor: Same as current
• Collaborators: Genentech, Inc.

Investigators

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

• PRS Account: Memorial Healthcare System
• Verification Date: March 2024