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Fibrinolytic Agent

Fibrinolytic Therapy for Pleural Effusion

Phase 4
Waitlist Available
Led By Mark Block, MD
Research Sponsored by Memorial Healthcare System
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Symptomatic pleural effusion requiring intervention
Age > 18 years
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 months
Awards & highlights

Study Summary

This trial is testing whether a fibrinolytic drug given intrapleurally can help with chemical pleurodesis (a treatment for recurrent pleural effusion) compared to the standard talc therapy.

Who is the study for?
This trial is for adults over 18 with a symptomatic pleural effusion needing treatment and expected to live more than 3 months. It's not for pregnant or breastfeeding women, those who can't consent or follow the protocol, or have had bad reactions to talc or Cathflo Activase.Check my eligibility
What is being tested?
The study compares two treatments: Intrapleural Fibrinolytic Therapy (using Cathflo Activase) combined with Talc Slurry Pleurodesis versus just Talc therapy. It's a prospective, randomized, double-blind controlled trial meaning patients are randomly assigned to groups without knowing which treatment they receive.See study design
What are the potential side effects?
Possible side effects may include pain at the injection site, allergic reactions to medications used, bleeding complications due to fibrinolytic therapy, respiratory issues from talc pleurodesis, and general discomfort.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I need treatment for fluid buildup in my chest causing symptoms.
Select...
I am older than 18 years.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Positive Change in successful pleurodesis rates
Secondary outcome measures
Incidence of Complications

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Talc Slurry Pleurodesis (TSP) plus Cathflo ActivaseExperimental Treatment2 Interventions
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 II: Talc Slurry Pleurodesis (TSP) plus placeboPlacebo Group1 Intervention
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
First Studied
Drug Approval Stage
How many patients have taken this drug
Alteplase
FDA approved
Talc
FDA approved

Find a Location

Who is running the clinical trial?

Memorial Healthcare SystemLead Sponsor
8 Previous Clinical Trials
1,258 Total Patients Enrolled
Genentech, Inc.Industry Sponsor
1,541 Previous Clinical Trials
568,064 Total Patients Enrolled
3 Trials studying Pleural Effusion
195 Patients Enrolled for Pleural Effusion
Mark Block, MDPrincipal InvestigatorChief, Thoracic Surgery

Media Library

Cathflo Activase (Fibrinolytic Agent) Clinical Trial Eligibility Overview. Trial Name: NCT04806373 — Phase 4
Pleural Effusion Research Study Groups: Talc Slurry Pleurodesis (TSP) plus placebo, Talc Slurry Pleurodesis (TSP) plus Cathflo Activase
Pleural Effusion Clinical Trial 2023: Cathflo Activase Highlights & Side Effects. Trial Name: NCT04806373 — Phase 4
Cathflo Activase (Fibrinolytic Agent) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04806373 — Phase 4

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does this trial currently have openings to participate?

"As documented on clinicaltrials.gov, this medical trial is currently enrolling patients. The study was initially announced on June 15th 2021 and the details were last updated August 22nd 2022."

Answered by AI

What prior research has evaluated the efficacy of Cathflo Activase?

"Presently, there are 22 Cathflo Activase trials taking place; 15 of which are in the final phase. The majority of these investigations originate from Hollywood, Florida while 418 other centres nationwide have studies revolving around this therapeutic agent."

Answered by AI

What diseases has Cathflo Activase been effective in treating?

"Cathflo Activase is usually prescribed for diaper rash, yet its usage can be extended to treat other pathologies such as thrombosis, skin irritation and malignant pleural effusion."

Answered by AI

What is the current level of recruitment for this trial?

"Indeed, according to clinicaltrials.gov this research is still enrolling participants. The trial was initially posted on June 15th 2021 and the details were recently updated August 22nd 2022. This study hopes to recruit a total of 136 patients from one medical centre."

Answered by AI

Has Cathflo Activase earned official recognition from the FDA?

"The safety rating for Cathflo Activase has been evaluated to be a 3, reflecting its Phase 4 status and indicating that the drug is approved."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Intrapleural Fibrinolytic Therapy to Enhance Chemical Pleurodesis Enhance Chemical Pleurodesis
2021. "Intrapleural Fibrinolytic Therapy to Enhance Chemical Pleurodesis Enhance Chemical Pleurodesis". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04806373.
~7 spots leftby May 2025
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