Status:

COMPLETED

Intrapleural Fibrinolytic Therapy to Enhance Chemical Pleurodesis Enhance Chemical Pleurodesis

Lead Sponsor:

Memorial Healthcare System

Collaborating Sponsors:

Genentech, Inc.

Conditions:

Pleural Effusion

Eligibility:

All Genders

18+ years

Phase:

PHASE4

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 effusi...

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 ...

Eligibility Criteria

Inclusion

  • Age \> 18 years
  • Symptomatic pleural effusion requiring intervention
  • Expected survival \> 3 months
  • Written informed consent to trial participation

Exclusion

  • 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

Key Trial Info

Start Date :

June 15 2021

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

December 14 2023

Estimated Enrollment :

27 Patients enrolled

Trial Details

Trial ID

NCT04806373

Start Date

June 15 2021

End Date

December 14 2023

Last Update

June 8 2025

Active Locations (1)

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1

Memorial Healthcare System

Hollywood, Florida, United States, 33021