Intrapleural Fibrinolytic Therapy to Enhance Chemical Pleurodesis Enhance Chemical Pleurodesis

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Pleural Effusion

Intervention / Treatment
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* Drug: Cathflo Activase
* Drug: Talc Slurry Pleurodesis


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age > 18 years Symptomatic pleural effusion requiring intervention Expected survival > 3 months Written informed consent to trial participation Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: single center, prospective, randomized, double-blind, placebo-controlled trial with two arms
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Talc Slurry Pleurodesis (TSP) plus placebo<br>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<br>* Talc, 5 gm in 50 ml Normal Saline given through chest pleural catheter<br>* Other names: TSP;|
| Experimental: Talc Slurry Pleurodesis (TSP) plus Cathflo Activase<br>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<br>* Cathflo Activase 4mg in 50ml normal saline given through chest pleural catheter<br>Drug: Talc Slurry Pleurodesis<br>* Talc, 5 gm in 50 ml Normal Saline given through chest pleural catheter<br>* Other names: TSP;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |