Intrapleural Fibrinolytic Therapy to Enhance Chemical Pleurodesis Enhance Chemical Pleurodesis

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

27 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-06-15

Study Completion Date

2023-12-14

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.

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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.

Conditions

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Pleural Effusion

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

single center, prospective, randomized, double-blind, placebo-controlled trial with two arms

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Double blind. Pharmacist will be unblinded.

Study Groups

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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.

Group Type PLACEBO_COMPARATOR

Talc Slurry Pleurodesis

Intervention Type DRUG

Talc, 5 gm in 50 ml Normal Saline given through chest pleural catheter

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

Group Type EXPERIMENTAL

Cathflo Activase

Intervention Type DRUG

Cathflo Activase 4mg in 50ml normal saline given through chest pleural catheter

Talc Slurry Pleurodesis

Intervention Type DRUG

Talc, 5 gm in 50 ml Normal Saline given through chest pleural catheter

Interventions

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Cathflo Activase

Cathflo Activase 4mg in 50ml normal saline given through chest pleural catheter

Intervention Type DRUG

Talc Slurry Pleurodesis

Talc, 5 gm in 50 ml Normal Saline given through chest pleural catheter

Intervention Type DRUG

Other Intervention Names

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TSP

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No