Pleural EffusionPhase 4NCT04806373
Intrapleural Fibrinolytic Therapy to Enhance Chemical Pleurodesis Enhance Chemical Pleurodesis
A Phase 4 study testing Cathflo Activase and Talc Slurry Pleurodesis in people with Pleural Effusion, run by Memorial Healthcare System at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pleural Effusion
- What is being tested?
- Cathflo Activase and Talc Slurry Pleurodesis
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 27 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Jun 2021to 14 Dec 2023
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age > 18 years
- Symptomatic pleural effusion requiring intervention
- Expected survival > 3 months
- Written informed consent to trial participation
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Memorial Healthcare System
Hollywood, Florida, 33021
About this study
Official title: Prospective Randomized Double-Blind Controlled Trial of Intrapleural Fibrinolytic Therapy to Enhance Chemical Pleurodesis
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.
Read the 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.
- Conditions
- Pleural Effusion
- Being tested
- Cathflo Activase, Talc Slurry Pleurodesis
- Medical subject headings
- Pleural Effusion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cathflo ActivaseDrug
Cathflo Activase 4mg in 50ml normal saline given through chest pleural catheter
Talc Slurry PleurodesisDrug
Also called TSP
Talc, 5 gm in 50 ml Normal Saline given through chest pleural catheter
| Study group | Role | What they receive |
|---|---|---|
| Talc Slurry Pleurodesis (TSP) plus placebo | Placebo comparator | 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. Receives: Drug: Talc Slurry Pleurodesis |
| Talc Slurry Pleurodesis (TSP) plus Cathflo Activase | Experimental | 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 Receives: Drug: Cathflo Activase; Drug: Talc Slurry Pleurodesis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Chest X-ray Results on Day 3 After Pleurodesis
Evaluate whether the chest x-ray is better (+1), the same (0), or worse (-1) than it was on the day of pleurodesis
Measured: 3-5 days
Secondary outcomes (9)
Pleural Drainage Volume (mL) After Pleurodesis
Total volume of drainage on days 1-3 after pleurodesis
Measured: 3 days
Dyspnea on Day 3 After Pleurodesis
Borg dyspnea scale complete by patient on day 3 after pleurodesis, on a scale of 0 to 10, with 10 being worst.
Measured: 3 days
Pain Score
Visual analog scale for self-reported level of pain at three days after pleurodesis, from 0 to 100 with 100 being worst pain.
Measured: 3 days
Chest Tube Size
Size of the chest tube used for pleural fluid drainage and talc slurry pleurodesis
Measured: day 1
Time to Chest Tube Removal
Number of days from pleurodesis to removal of the last chest tube
Measured: Days from pleurodesis to chest tube removal
Length of Stay
Total duration of hospital stay from admission to discharge, including time before pleurodesis
Measured: days
Radiographically Satisfactory Pleurodesis
Number (proportion) of patients who achieved daily chest tube drainage of less than 100 cc/24 hours, with the chest x-ray showing no evidence of accumulation of pleural fluid since pleurodesis.
Measured: days
Time to Achieve Radiographically Satisfactory Pleurodesis
Days from pleurodesis to the point at which pleurodesis is deemed successful and complete
Measured: days
30 Day Mortality
Number of patients who died within 30 days of pleurodesis
Measured: 30 days from pleurodesis
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2021
- Study start15 Jun 2021
- Primary completion14 Dec 2023
- Study completion14 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Pleural EffusionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- single center, prospective, randomized, double-blind, placebo-controlled trial with two arms
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- Memorial Healthcare System
- Sponsor type
- University, hospital or other
- Collaborators
- Genentech, Inc.
- Responsible party
- Sponsor
- Investigators
- Mark Block, MD, Principal investigator, Chief, Thoracic Surgery
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04806373
- Sponsor's protocol ID
- MHS 2020.144
- Other IDs
- ML42028
- Status last verified
- May 2025
- First submitted
- 16 Mar 2021
- Last updated
- 8 Jun 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: Single center study
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Randomized Double-Blind Controlled Trial of Intrapleural Fibrinolytic Therapy to Enhance Chemical Pleurodesis
- ClinicalTrials.gov ID
- NCT04806373
- Acronym / sponsor ID
- MHS 2020.144
- Conditions
- Pleural Effusion
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- Memorial Healthcare SystemUniversity, hospital or other
- Collaborators
- Genentech, Inc.
- Study start
- 15 Jun 2021 (actual)
- Primary completion
- 14 Dec 2023 (actual)
- Study completion
- 14 Dec 2023 (actual)
- First posted
- 19 Mar 2021 (actual)
- Results
- Posted 11 Dec 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- Model description
- single center, prospective, randomized, double-blind, placebo-controlled trial with two arms
| Arm | Type | Receives |
|---|---|---|
| Talc Slurry Pleurodesis (TSP) plus placebo | Placebo comparator | Drug: Talc Slurry PleurodesisPatients 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 | Experimental | Drug: Cathflo Activase, Drug: Talc Slurry PleurodesisPatients 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age > 18 years
- Symptomatic pleural effusion requiring intervention
- Expected survival > 3 months
- Written informed consent to trial participation
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cathflo ActivaseCathflo Activase 4mg in 50ml normal saline given through chest pleural catheter | Drug | Talc Slurry Pleurodesis (TSP) plus Cathflo Activase |
| Talc Slurry PleurodesisAlso: TSPTalc, 5 gm in 50 ml Normal Saline given through chest pleural catheter | Drug | Talc Slurry Pleurodesis (TSP) plus Cathflo Activase, Talc Slurry Pleurodesis (TSP) plus placebo |
Primary outcome
Chest X-ray Results on Day 3 After Pleurodesis
Time frame: 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
9 secondary outcomes
Pleural Drainage Volume (mL) After Pleurodesis
Time frame: 3 days
Dyspnea on Day 3 After Pleurodesis
Time frame: 3 days
Pain Score
Time frame: 3 days
Chest Tube Size
Time frame: day 1
Time to Chest Tube Removal
Time frame: Days from pleurodesis to chest tube removal
Length of Stay
Time frame: days
Radiographically Satisfactory Pleurodesis
Time frame: days
Time to Achieve Radiographically Satisfactory Pleurodesis
Time frame: days
30 Day Mortality
Time frame: 30 days from pleurodesis
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jun 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No. Single center study
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mark Block, MD principal investigator
Chief, Thoracic Surgery
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Cathflo Activase and Talc Slurry Pleurodesis in people with Pleural Effusion, run by Memorial Healthcare System at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 11 Dec 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Chest X-ray Results on Day 3 After Pleurodesis (time frame: 3-5 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jun 2025.