Intrapleural Fibrinolytic Therapy to Enhance Chemical Pleurodesis Enhance Chemical Pleurodesis

Pleural Effusion Clinical Trial

Official title:

Prospective Randomized Double-Blind Controlled Trial of Intrapleural Fibrinolytic Therapy to Enhance Chemical Pleurodesis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04806373
• Other study ID #: MHS 2020.144
• Secondary ID: ML42028
• Status: Completed
• Phase: Phase 4
• Start date: June 15, 2021
• Est. completion date: December 14, 2023

Study information

• Verified date: March 2024
• Source: Memorial Healthcare System
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 27
• Est. completion date: December 14, 2023
• Est. primary completion date: December 14, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Pleural Effusion

Intervention

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

Locations

Country	Name	City	State
United States	Memorial Healthcare System	Hollywood	Florida

Sponsors (2)

Lead Sponsor	Collaborator
Memorial Healthcare System	Genentech, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Positive Change in successful pleurodesis rates	To determine if intrapleural administration of Talc slurry with cathflo activase will improve successful pleurodesis rates compared to talc slurry alone.	3-5 days
Secondary	Incidence of Complications	To determine if giving cathflo activase with TSP is associated with a higher incidence of complications compared to TSP with placebo.	3 months