Intrapleural Fibrinolytic Therapy to Enhance Chemical Pleurodesis Enhance Chemical Pleurodesis

Phase 4

Completed

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.

Recruitment & Eligibility

Inclusion Criteria

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

Arm && Interventions

Group	Intervention	Description
Talc Slurry Pleurodesis (TSP) plus placebo	Talc Slurry Pleurodesis	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.
Talc Slurry Pleurodesis (TSP) plus Cathflo Activase	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
Talc Slurry Pleurodesis (TSP) plus Cathflo Activase	Talc Slurry Pleurodesis	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

Primary Outcome Measures

Name	Time	Method
Chest X-ray Results on Day 3 After Pleurodesis	3-5 days	Evaluate whether the chest x-ray is better (+1), the same (0), or worse (-1) than it was on the day of pleurodesis

Secondary Outcome Measures

Name	Time	Method
Pleural Drainage Volume (mL) After Pleurodesis	3 days	Total volume of drainage on days 1-3 after pleurodesis
Dyspnea on Day 3 After Pleurodesis	3 days	Borg dyspnea scale complete by patient on day 3 after pleurodesis, on a scale of 0 to 10, with 10 being worst.
Pain Score	3 days	Visual analog scale for self-reported level of pain at three days after pleurodesis, from 0 to 100 with 100 being worst pain.
Chest Tube Size	day 1	Size of the chest tube used for pleural fluid drainage and talc slurry pleurodesis
Time to Chest Tube Removal	Days from pleurodesis to chest tube removal	Number of days from pleurodesis to removal of the last chest tube
Length of Stay	days	Total duration of hospital stay from admission to discharge, including time before pleurodesis
Radiographically Satisfactory Pleurodesis	days	Time to when daily drainage is less than 100 cc/24 hours, and the chest x-ray shows no evidence of accumulation of pleural fluid since pleurodesis.
Time to Achieve Radiographically Satisfactory Pleurodesis	days	Days from pleurodesis to the point at which pleurodesis is deemed succesful and complete
30 Day Mortality	30 days from pleurodesis	Number of patients who died within 30 days of pleurodesis