Trial Outcomes & Findings for Intrapleural Fibrinolytic Therapy to Enhance Chemical Pleurodesis Enhance Chemical Pleurodesis (NCT NCT04806373)
NCT ID: NCT04806373
Last Updated: 2025-06-08
Results Overview
Evaluate whether the chest x-ray is better (+1), the same (0), or worse (-1) than it was on the day of pleurodesis
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
27 participants
Primary outcome timeframe
3-5 days
Results posted on
2025-06-08
Participant Flow
Participant milestones
| Measure |
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.
Talc Slurry Pleurodesis: 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
Cathflo Activase: Cathflo Activase 4mg in 50ml normal saline given through chest pleural catheter
Talc Slurry Pleurodesis: Talc, 5 gm in 50 ml Normal Saline given through chest pleural catheter
|
|---|---|---|
|
Overall Study
STARTED
|
12
|
15
|
|
Overall Study
COMPLETED
|
11
|
14
|
|
Overall Study
NOT COMPLETED
|
1
|
1
|
Reasons for withdrawal
| Measure |
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.
Talc Slurry Pleurodesis: 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
Cathflo Activase: Cathflo Activase 4mg in 50ml normal saline given through chest pleural catheter
Talc Slurry Pleurodesis: Talc, 5 gm in 50 ml Normal Saline given through chest pleural catheter
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
1
|
Baseline Characteristics
Intrapleural Fibrinolytic Therapy to Enhance Chemical Pleurodesis Enhance Chemical Pleurodesis
Baseline characteristics by cohort
| Measure |
Talc Slurry Pleurodesis (TSP) Plus Placebo
n=12 Participants
Patients who sign informed consent may be randomized to receive talc slurry pleurodesis (TSP) alone (talc, 5 gm in 50 ml NS) with placebo (50 ml Normal saline (NS)) through the chest pleural catheter.
Talc Slurry Pleurodesis: Talc, 5 gm in 50 ml Normal Saline given through chest pleural catheter
|
Talc Slurry Pleurodesis (TSP) Plus Cathflo Activase
n=15 Participants
Patients who sign informed consent may be randomized to receive talc slurry pleurodesis (TSP) (Talc, 5mg in 50ml Normal saline (NS)) with cathflo activase (4 mg in 50 ml NS) through the chest pleural catheter
Cathflo Activase: Cathflo Activase 4mg in 50ml normal saline given through chest pleural catheter
Talc Slurry Pleurodesis: Talc, 5 gm in 50 ml Normal Saline given through chest pleural catheter
|
Total
n=27 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
66.9 years
STANDARD_DEVIATION 14.5 • n=99 Participants
|
64.6 years
STANDARD_DEVIATION 15.8 • n=107 Participants
|
65.7 years
STANDARD_DEVIATION 14.9 • n=206 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=99 Participants
|
12 Participants
n=107 Participants
|
16 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
11 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
4 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
9 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
8 Participants
n=99 Participants
|
10 Participants
n=107 Participants
|
18 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
11 Participants
n=99 Participants
|
11 Participants
n=107 Participants
|
22 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
12 participants
n=99 Participants
|
15 participants
n=107 Participants
|
27 participants
n=206 Participants
|
|
BMI
|
23.5 kg/m^2
STANDARD_DEVIATION 3.1 • n=99 Participants
|
24.8 kg/m^2
STANDARD_DEVIATION 4.5 • n=107 Participants
|
24.2 kg/m^2
STANDARD_DEVIATION 3.9 • n=206 Participants
|
|
Effusion etiology
Lung cancer
|
4 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
8 Participants
n=206 Participants
|
|
Effusion etiology
Other malignant
|
6 Participants
n=99 Participants
|
9 Participants
n=107 Participants
|
15 Participants
n=206 Participants
|
|
Effusion etiology
Liver disease
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Effusion etiology
Unknown
|
1 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
|
Effusion laterality
Left
|
4 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
7 Participants
n=206 Participants
|
|
Effusion laterality
Right
|
5 Participants
n=99 Participants
|
10 Participants
n=107 Participants
|
15 Participants
n=206 Participants
|
|
Effusion laterality
Bilateral
|
3 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
5 Participants
n=206 Participants
|
|
Prior pleural intervention
|
11 Participants
n=99 Participants
|
14 Participants
n=107 Participants
|
25 Participants
n=206 Participants
|
|
Trapped lung
|
4 Participants
n=99 Participants
|
8 Participants
n=107 Participants
|
12 Participants
n=206 Participants
|
|
Effusion size
Small (<500 ml)
|
8 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
13 Participants
n=206 Participants
|
|
Effusion size
Moderate (500 - 1000 ml)
|
2 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
8 Participants
n=206 Participants
|
|
Effusion size
Large (>1000 ml)
|
2 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
6 Participants
n=206 Participants
|
|
Dyspnea score
|
0.9 units on a scale from 0 to 10, 10 worst
STANDARD_DEVIATION 1.2 • n=99 Participants
|
0.5 units on a scale from 0 to 10, 10 worst
STANDARD_DEVIATION 1.5 • n=107 Participants
|
0.7 units on a scale from 0 to 10, 10 worst
STANDARD_DEVIATION 1.3 • n=206 Participants
|
|
Chest pain Visual Analog Scale (VAS)
|
23.3 Scale from 0 to 100; with 100 worst pain
STANDARD_DEVIATION 32.4 • n=99 Participants
|
11.9 Scale from 0 to 100; with 100 worst pain
STANDARD_DEVIATION 28.2 • n=107 Participants
|
17.6 Scale from 0 to 100; with 100 worst pain
STANDARD_DEVIATION 30.2 • n=206 Participants
|
PRIMARY outcome
Timeframe: 3-5 daysEvaluate whether the chest x-ray is better (+1), the same (0), or worse (-1) than it was on the day of pleurodesis
Outcome measures
| Measure |
Talc Slurry Pleurodesis (TSP) Plus Placebo
n=12 Participants
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.
Talc Slurry Pleurodesis: Talc, 5 gm in 50 ml Normal Saline given through chest pleural catheter
|
Talc Slurry Pleurodesis (TSP) Plus Cathflo Activase
n=15 Participants
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
Cathflo Activase: Cathflo Activase 4mg in 50ml normal saline given through chest pleural catheter
Talc Slurry Pleurodesis: Talc, 5 gm in 50 ml Normal Saline given through chest pleural catheter
|
|---|---|---|
|
Chest X-ray Results on Day 3 After Pleurodesis
Worse
|
5 Participants
|
6 Participants
|
|
Chest X-ray Results on Day 3 After Pleurodesis
Same
|
5 Participants
|
8 Participants
|
|
Chest X-ray Results on Day 3 After Pleurodesis
Better
|
2 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: 3 daysTotal volume of drainage on days 1-3 after pleurodesis
Outcome measures
| Measure |
Talc Slurry Pleurodesis (TSP) Plus Placebo
n=12 Participants
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.
Talc Slurry Pleurodesis: Talc, 5 gm in 50 ml Normal Saline given through chest pleural catheter
|
Talc Slurry Pleurodesis (TSP) Plus Cathflo Activase
n=15 Participants
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
Cathflo Activase: Cathflo Activase 4mg in 50ml normal saline given through chest pleural catheter
Talc Slurry Pleurodesis: Talc, 5 gm in 50 ml Normal Saline given through chest pleural catheter
|
|---|---|---|
|
Pleural Drainage Volume (mL) After Pleurodesis
Day 1
|
125 ml
Interval 75.0 to 350.0
|
427.5 ml
Interval 337.5 to 685.0
|
|
Pleural Drainage Volume (mL) After Pleurodesis
Day 2
|
39 ml
Interval 15.0 to 240.0
|
150 ml
Interval 55.0 to 225.0
|
|
Pleural Drainage Volume (mL) After Pleurodesis
Day 3
|
45 ml
Interval 0.0 to 135.0
|
100 ml
Interval 50.0 to 200.0
|
SECONDARY outcome
Timeframe: 3 daysBorg dyspnea scale complete by patient on day 3 after pleurodesis, on a scale of 0 to 10, with 10 being worst.
Outcome measures
| Measure |
Talc Slurry Pleurodesis (TSP) Plus Placebo
n=12 Participants
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.
Talc Slurry Pleurodesis: Talc, 5 gm in 50 ml Normal Saline given through chest pleural catheter
|
Talc Slurry Pleurodesis (TSP) Plus Cathflo Activase
n=15 Participants
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
Cathflo Activase: Cathflo Activase 4mg in 50ml normal saline given through chest pleural catheter
Talc Slurry Pleurodesis: Talc, 5 gm in 50 ml Normal Saline given through chest pleural catheter
|
|---|---|---|
|
Dyspnea on Day 3 After Pleurodesis
|
1 score on a scale from 0 to 10
Interval 0.0 to 3.0
|
1 score on a scale from 0 to 10
Interval 0.0 to 1.5
|
SECONDARY outcome
Timeframe: 3 daysVisual analog scale for self-reported level of pain at three days after pleurodesis, from 0 to 100 with 100 being worst pain.
Outcome measures
| Measure |
Talc Slurry Pleurodesis (TSP) Plus Placebo
n=12 Participants
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.
Talc Slurry Pleurodesis: Talc, 5 gm in 50 ml Normal Saline given through chest pleural catheter
|
Talc Slurry Pleurodesis (TSP) Plus Cathflo Activase
n=15 Participants
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
Cathflo Activase: Cathflo Activase 4mg in 50ml normal saline given through chest pleural catheter
Talc Slurry Pleurodesis: Talc, 5 gm in 50 ml Normal Saline given through chest pleural catheter
|
|---|---|---|
|
Pain Score
|
10 score on a scale from 0 to 100
Interval 0.0 to 29.5
|
10 score on a scale from 0 to 100
Interval 0.0 to 30.0
|
SECONDARY outcome
Timeframe: day 1Size of the chest tube used for pleural fluid drainage and talc slurry pleurodesis
Outcome measures
| Measure |
Talc Slurry Pleurodesis (TSP) Plus Placebo
n=12 Participants
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.
Talc Slurry Pleurodesis: Talc, 5 gm in 50 ml Normal Saline given through chest pleural catheter
|
Talc Slurry Pleurodesis (TSP) Plus Cathflo Activase
n=15 Participants
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
Cathflo Activase: Cathflo Activase 4mg in 50ml normal saline given through chest pleural catheter
Talc Slurry Pleurodesis: Talc, 5 gm in 50 ml Normal Saline given through chest pleural catheter
|
|---|---|---|
|
Chest Tube Size
10 Fr
|
4 Participants
|
4 Participants
|
|
Chest Tube Size
12 Fr
|
4 Participants
|
4 Participants
|
|
Chest Tube Size
14 Fr
|
2 Participants
|
2 Participants
|
|
Chest Tube Size
Unknown
|
2 Participants
|
5 Participants
|
SECONDARY outcome
Timeframe: Days from pleurodesis to chest tube removalNumber of days from pleurodesis to removal of the last chest tube
Outcome measures
| Measure |
Talc Slurry Pleurodesis (TSP) Plus Placebo
n=12 Participants
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.
Talc Slurry Pleurodesis: Talc, 5 gm in 50 ml Normal Saline given through chest pleural catheter
|
Talc Slurry Pleurodesis (TSP) Plus Cathflo Activase
n=15 Participants
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
Cathflo Activase: Cathflo Activase 4mg in 50ml normal saline given through chest pleural catheter
Talc Slurry Pleurodesis: Talc, 5 gm in 50 ml Normal Saline given through chest pleural catheter
|
|---|---|---|
|
Time to Chest Tube Removal
|
7 days
Interval 5.0 to 14.0
|
9 days
Interval 5.0 to 12.0
|
SECONDARY outcome
Timeframe: daysTotal duration of hospital stay from admission to discharge, including time before pleurodesis
Outcome measures
| Measure |
Talc Slurry Pleurodesis (TSP) Plus Placebo
n=12 Participants
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.
Talc Slurry Pleurodesis: Talc, 5 gm in 50 ml Normal Saline given through chest pleural catheter
|
Talc Slurry Pleurodesis (TSP) Plus Cathflo Activase
n=15 Participants
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
Cathflo Activase: Cathflo Activase 4mg in 50ml normal saline given through chest pleural catheter
Talc Slurry Pleurodesis: Talc, 5 gm in 50 ml Normal Saline given through chest pleural catheter
|
|---|---|---|
|
Length of Stay
|
10 days
Interval 6.0 to 26.0
|
11 days
Interval 7.0 to 15.0
|
SECONDARY outcome
Timeframe: daysNumber (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.
Outcome measures
| Measure |
Talc Slurry Pleurodesis (TSP) Plus Placebo
n=12 Participants
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.
Talc Slurry Pleurodesis: Talc, 5 gm in 50 ml Normal Saline given through chest pleural catheter
|
Talc Slurry Pleurodesis (TSP) Plus Cathflo Activase
n=15 Participants
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
Cathflo Activase: Cathflo Activase 4mg in 50ml normal saline given through chest pleural catheter
Talc Slurry Pleurodesis: Talc, 5 gm in 50 ml Normal Saline given through chest pleural catheter
|
|---|---|---|
|
Radiographically Satisfactory Pleurodesis
|
8 Participants
|
12 Participants
|
SECONDARY outcome
Timeframe: daysDays from pleurodesis to the point at which pleurodesis is deemed successful and complete
Outcome measures
| Measure |
Talc Slurry Pleurodesis (TSP) Plus Placebo
n=12 Participants
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.
Talc Slurry Pleurodesis: Talc, 5 gm in 50 ml Normal Saline given through chest pleural catheter
|
Talc Slurry Pleurodesis (TSP) Plus Cathflo Activase
n=15 Participants
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
Cathflo Activase: Cathflo Activase 4mg in 50ml normal saline given through chest pleural catheter
Talc Slurry Pleurodesis: Talc, 5 gm in 50 ml Normal Saline given through chest pleural catheter
|
|---|---|---|
|
Time to Achieve Radiographically Satisfactory Pleurodesis
|
5.75 days
Standard Deviation 6.27
|
4.83 days
Standard Deviation 3.43
|
SECONDARY outcome
Timeframe: 30 days from pleurodesisNumber of patients who died within 30 days of pleurodesis
Outcome measures
| Measure |
Talc Slurry Pleurodesis (TSP) Plus Placebo
n=12 Participants
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.
Talc Slurry Pleurodesis: Talc, 5 gm in 50 ml Normal Saline given through chest pleural catheter
|
Talc Slurry Pleurodesis (TSP) Plus Cathflo Activase
n=15 Participants
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
Cathflo Activase: Cathflo Activase 4mg in 50ml normal saline given through chest pleural catheter
Talc Slurry Pleurodesis: Talc, 5 gm in 50 ml Normal Saline given through chest pleural catheter
|
|---|---|---|
|
30 Day Mortality
|
4 participants
|
5 participants
|
Adverse Events
Talc Slurry Pleurodesis (TSP) Plus Placebo
Serious events: 0 serious events
Other events: 0 other events
Deaths: 4 deaths
Talc Slurry Pleurodesis (TSP) Plus Cathflo Activase
Serious events: 0 serious events
Other events: 0 other events
Deaths: 5 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Mark Block, Chief, Division of Thoracic Surgery
Memorial Healthcare System
Phone: 9542651125
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place