Intrapleural Fibrinolytic Therapy to Enhance Chemical Pleurodesis Enhance Chemical Pleurodesis

Memorial Healthcare System

Status and phase: Completed; Phase 4

Conditions: Pleural Effusion

Treatments: Drug: Talc Slurry Pleurodesis; Drug: Cathflo Activase

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT04806373

MHS 2020.144

ML42028 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 27 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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27 participants in 2 patient groups, including a placebo group

Talc Slurry Pleurodesis (TSP) plus placebo

Placebo Comparator group

Description:

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.

Treatment:

Drug: Talc Slurry Pleurodesis

Talc Slurry Pleurodesis (TSP) plus Cathflo Activase

Experimental group

Description:

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

Treatment:

Drug: Cathflo Activase

Drug: Talc Slurry Pleurodesis