Pleural Effusion Clinical Trial
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.
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. ;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT04159831 -
A Study to Evaluate LTI-01 in Patients With Infected, Non-draining Pleural Effusions
|
Phase 2 | |
| Recruiting |
NCT02891642 -
Liquid Biopsy With Immunomagnetic Beads Capture Technique for Malignant Cell Detection in Body Fluid
|
||
| Completed |
NCT02232841 -
Electrical Impedance Imaging of Patients on Mechanical Ventilation
|
N/A | |
| Completed |
NCT02045641 -
Pleural and Pericardial Effusion Following Open Heart Surgery
|
N/A | |
| Completed |
NCT01948076 -
Evaluation of a Pocket-Sized Ultrasound Device As an Aid to the Physical Examination
|
N/A | |
| Completed |
NCT01416519 -
Physiotherapy Technique Decreases Respiratory Complications After Cardiac Operation
|
N/A | |
| Completed |
NCT01560078 -
Efficacy Study of Thrice Weekly Directly Observed Treatment Short-Course Regimen in Tubercular Pleural Effusion
|
N/A | |
| Completed |
NCT04891705 -
Point of Care Ultrasound Lung Artificial Intelligence (AI) Validation Data Collection Study
|
||
| Recruiting |
NCT05759117 -
Prospective Evaluation of Patients With Pleural Effusion
|
||
| Recruiting |
NCT05910112 -
Prospective Data Collection on Clinical, Radiological and Patient Reported Outcomes After Pleural Intervention
|
||
| Completed |
NCT03896672 -
Clinical Implementation of the Use of Positive Pressure in Chest Drainage
|
N/A | |
| Active, not recruiting |
NCT06075836 -
AI Assisted Detection of Chest X-Rays
|
||
| Recruiting |
NCT03728491 -
Education and Training Competences in Thoracic Ultrasound
|
N/A | |
| Not yet recruiting |
NCT03260088 -
Evaluation Of Pleural Effusion At Assiut University Hospital
|
N/A | |
| Completed |
NCT03535883 -
The Safety of Thoracentesis, Tunneled Pleural Catheter, and Chest Tubes in Patients Taking Novel Oral Anti-Coagulants
|
||
| Completed |
NCT03296280 -
Evaluation of Implementation of a National Point-of-Care Ultrasound Training Program
|
||
| Completed |
NCT03661801 -
Novel Pleural Fluid, Biopsy and Serum Biomarkers for the Investigation of Pleural Effusions
|
||
| Completed |
NCT01778270 -
Not Invasive Monitoring of Pleural Drainage
|
N/A | |
| Terminated |
NCT00402896 -
Malignant Pleural Effusion With ZD6474
|
Phase 2 | |
| Recruiting |
NCT00103766 -
Alteplase for Treatment of Empyema and Complicated Parapneumonic Effusion
|
N/A |