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Alteplase Through an Indwelling Pleural Catheter for the Management of Symptomatic Septated Malignant Pleural Effusion

Malignant Solid Neoplasm Clinical Trial

Official title:
A Randomized Trial of Alteplase Versus Placebo Through an Indwelling Pleural Catheter for Management of Symptomatic Septated MPE

Clinical Trial Summary

This study investigates whether alteplase can help to improve pleural fluid drainage and dyspnea (breathlessness) in patients with non-draining malignant pleural effusion. Alteplase helps dissolve blood clots and is used to treat heart attacks, strokes, and clots in the lungs. Alteplase may help to control symptoms of breathlessness.

Clinical Trial Description

PRIMARY OBJECTIVE: I. To evaluate dyspnea using the Borg score at one week in patients with symptomatic septated malignant pleural effusion (MPE) and indwelling pleural catheter (IPC) with inability to drain fully that are treated with intrapleural alteplase. SECONDARY OBJECTIVE: I. To evaluate dyspnea using the visual analog scale (VAS) scale at one week in patients with septated MPE and IPC and inability to drain fully that are treated with intrapleural alteplase. OUTLINE: Patients are randomized to 1 of 2 arms. ARM I: Patients receive alteplase instilled into the IPC which is capped for 1-2 hours before the catheter is drained. ARM II: Patients receive placebo instilled into the IPC which is capped for 1-2 hours before the catheter is drained. Beginning 1 week later, patients may receive alteplase as in arm I. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT06184321
Study type Interventional
Source M.D. Anderson Cancer Center
Contact Horiana Grosu, M D
Phone 713-792-6238
Email hbgrosu@mdanderson.org
Status Recruiting
Phase Early Phase 1
Start date August 17, 2023
Completion date February 2, 2027
View Details
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