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Brief Title: Alteplase Through an Indwelling Pleural Catheter for the Management of Symptomatic Septated Malignant Pleural Effusion
Official Title: A Randomized Trial of Alteplase Versus Placebo Through an Indwelling Pleural Catheter for Management of Symptomatic Septated MPE
Study ID: NCT06184321
Brief 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.
Detailed 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.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
M D Anderson Cancer Center, Houston, Texas, United States
Name: Horiana Grosu, M D
Affiliation: M.D. Anderson Cancer Center
Role: PRINCIPAL_INVESTIGATOR