The BLAST Trial- Biomarker Levels During Indwelling Pleural cAtheter Sample Testing
Some patients that have a tunneled pleural catheter will not have the pleural fluid (water around the lung) return after some time (pleurodesis). The purpose of this study is to understand how the investigators can predict who will achieve pleurodesis and how this occurs by studying the pleural effusion.
|Study Design:||Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
|Official Title:||Biomarker Levels During Indwelling Pleural Catheter Sample|
- To determine the median time to pleurodesis [ Time Frame: 12 week follow up ] [ Designated as safety issue: No ]Duration of follow-up will be 12 weeks. After 12 weeks, all patients who do not achieve spontaneous pleurodesis will adhere to the standard drainage protocol.
- TGF-B levels over time [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]To determine the threshold TGF-B level to determine accuracy of predicting auto-pleurodesis
|Study Start Date:||January 2014|
|Estimated Study Completion Date:||January 2015|
|Estimated Primary Completion Date:||January 2015 (Final data collection date for primary outcome measure)|
|Active Comparator: Indwelling tunneled pleural catheter||Device: Rocket Indwelling Pleural Catheter|
|No Intervention: TGF-β markers|
An alternative and emerging treatment for malignant pleural effusions is the placement of a chronic indwelling pleural catheter such as the Rocket® catheter. The Rocket® catheter is a 16 French, 66 cm long, silicone catheter with side holes along its distal 24 cm. The proximal shaft has a polyester cuff designed to promote fibrosis in the subcutaneous tissue into which it is tunneled. This prevents dislodgement of the catheter and minimizes the risk of infection. The proximal end contains a self-sealing valve designed to enhance the safety of the catheter. The self-sealing valve prevents entry of air into the pleural space and inadvertent leakage of pleural fluid unless the catheter is accessed with the matched drainage line. The matched drainage line is connected to a 600 milliliter vacuum bottle. Pleural fluid is removed by inserting the access tip of the drainage line into the self-sealing valve of the Rocket® catheter, allowing vacuum drainage of the pleural space.
As discussed above, tunneled pleural catheters (TPC) are ideal for treatment of MPE associated with a trapped or non-expandable lung which will not have sufficient visceral and parietal pleura apposition for chemical pleurodesis. Transforming growth factor-Beta 1 (TGF-β) is a profibrotic cytokine, and a potent inducer of Plasminogen activator inhibitor-1 (PAI-1) in human pleural mesothelial cells. PAI-1 inhibits protease-dependent fibrinolytic activity and along with TGF-β, its concentration is increased in exudative and tuberculous pleural effusion. TGF-β levels in pleural fluid have been shown to correlate with pleural thickness in tuberculosis pleurisy and empyema in rabbits.
TGF-β is a multifunctional cytokine primarily produced by mesothelial cells in the pleural space, but can also originate from lung parenchymal macrophages that migrate to the pleural space. In humans, TGF-β consists of three isoforms (TGF-β1, TGF-β2, and TGF-β3). They share many biological activities and their actions on cells are qualitatively similar in most cases. TGF-β stimulates the extracellular matrix production and studies support that TGF-β over-production is a key regulator in pleural fibrosis and chemical pleurodesis. Moreover, TGF-β signaling for the production of PAI-1 is clearly noted in human mesothelial cells of different origins. Different inflammatory stimuli in the pleural space including malignancy and infection may activate TGF-β up-regulation and enhanced production which in turns results in PAI-1 expression.
Please refer to this study by its ClinicalTrials.gov identifier: NCT02092155
|Contact: Karen Oakjones-Burgessemail@example.com|
|Contact: Ricardo Ortizfirstname.lastname@example.org|
|United States, Maryland|
|Johns Hopkins University||Recruiting|
|Baltimore, Maryland, United States, 21287|
|Contact: Karen Oakjones-Burgess 410-955-5288|
|Principal Investigator:||Lonny Yarmus, DO||Johns Hopkins University|