Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| ML42028 | Other Identifier | Genentech |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Genentech, Inc. | INDUSTRY |
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cathflo Activase | Drug | Cathflo Activase 4mg in 50ml normal saline given through chest pleural catheter |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 3-5 days |
| Measure | Description | Time Frame |
|---|---|---|
| Pleural Drainage Volume (mL) After Pleurodesis | Total volume of drainage on days 1-3 after pleurodesis | 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. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Mark Block, MD | Chief, Thoracic Surgery | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Memorial Healthcare System | Hollywood | Florida | 33021 | United States |
Single center study
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| FG001 | 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 |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Talc Slurry Pleurodesis (TSP) Plus Placebo | 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 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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 | Posted | Count of Participants | Participants | 3-5 days |
|
60 days
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 |
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Mark Block, Chief, Division of Thoracic Surgery | Memorial Healthcare System | 9542651125 | mblock@mhs.net |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jan 17, 2023 | Jun 21, 2024 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Oct 9, 2023 | Jun 21, 2024 | ICF_001.pdf |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D010996 | Pleural Effusion |
| ID | Term |
|---|---|
| D010995 | Pleural Diseases |
| D012140 | Respiratory Tract Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D010959 | Tissue Plasminogen Activator |
| ID | Term |
|---|---|
| D012697 | Serine Endopeptidases |
| D010450 | Endopeptidases |
| D010447 | Peptide Hydrolases |
| D006867 | Hydrolases |
Not provided
Not provided
single center, prospective, randomized, double-blind, placebo-controlled trial with two arms
Not provided
Not provided
Double blind. Pharmacist will be unblinded.
| Talc Slurry Pleurodesis | Drug | Talc, 5 gm in 50 ml Normal Saline given through chest pleural catheter |
|
|
| 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. | 3 days |
| Chest Tube Size | Size of the chest tube used for pleural fluid drainage and talc slurry pleurodesis | day 1 |
| Time to Chest Tube Removal | Number of days from pleurodesis to removal of the last chest tube | Days from pleurodesis to chest tube removal |
| Length of Stay | Total duration of hospital stay from admission to discharge, including time before pleurodesis | 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. | days |
| Time to Achieve Radiographically Satisfactory Pleurodesis | Days from pleurodesis to the point at which pleurodesis is deemed successful and complete | days |
| 30 Day Mortality | Number of patients who died within 30 days of pleurodesis | 30 days from pleurodesis |
| BG001 |
| Talc Slurry Pleurodesis (TSP) Plus Cathflo Activase |
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 |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| BMI | Mean | Standard Deviation | kg/m^2 |
|
| Effusion etiology | Count of Participants | Participants |
|
| Effusion laterality | Count of Participants | Participants |
|
| Prior pleural intervention | Count of Participants | Participants |
|
| Trapped lung | Count of Participants | Participants |
|
| Effusion size | Count of Participants | Participants |
|
| Dyspnea score | Mean | Standard Deviation | units on a scale from 0 to 10, 10 worst |
|
| Chest pain Visual Analog Scale (VAS) | Mean | Standard Deviation | Scale from 0 to 100; with 100 worst pain |
|
|
|
|
| Secondary | Pleural Drainage Volume (mL) After Pleurodesis | Total volume of drainage on days 1-3 after pleurodesis | Posted | Median | Inter-Quartile Range | ml | 3 days |
|
|
|
|
| Secondary | 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. | Posted | Median | Inter-Quartile Range | score on a scale from 0 to 10 | 3 days |
|
|
|
|
| Secondary | 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. | Posted | Median | Inter-Quartile Range | score on a scale from 0 to 100 | 3 days |
|
|
|
|
| Secondary | Chest Tube Size | Size of the chest tube used for pleural fluid drainage and talc slurry pleurodesis | Posted | Count of Participants | Participants | day 1 |
|
|
|
|
| Secondary | Time to Chest Tube Removal | Number of days from pleurodesis to removal of the last chest tube | Posted | Median | Inter-Quartile Range | days | Days from pleurodesis to chest tube removal |
|
|
|
|
| Secondary | Length of Stay | Total duration of hospital stay from admission to discharge, including time before pleurodesis | Posted | Median | Inter-Quartile Range | days | days |
|
|
|
|
| Secondary | 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. | Posted | Count of Participants | Participants | days |
|
|
|
|
| Secondary | Time to Achieve Radiographically Satisfactory Pleurodesis | Days from pleurodesis to the point at which pleurodesis is deemed successful and complete | Posted | Mean | Standard Deviation | days | days |
|
|
|
|
| Secondary | 30 Day Mortality | Number of patients who died within 30 days of pleurodesis | Posted | Number | participants | 30 days from pleurodesis |
|
|
|
|
| 4 |
| 11 |
| 0 |
| 11 |
| 0 |
| 11 |
| EG001 | 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 | 5 | 14 | 0 | 14 | 0 | 14 |
Not provided
Not provided
| D004798 |
| Enzymes |
| D045762 | Enzymes and Coenzymes |
| D057057 | Serine Proteases |
| D010960 | Plasminogen Activators |
| D001779 | Blood Coagulation Factors |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D001685 | Biological Factors |
| Day 3 |
|
| 14 Fr |
|
| Unknown |
|