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Alteplase through an Indwelling Pleural Catheter for the Management of Symptomatic Septated Malignant Pleural Effusion
Trial Status: active
This early phase I trial 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. The alteplase can potentially break down the pockets of fluid, make them connect to each other and make the fluid drain out of the chest. Alteplase may help to control symptoms of breathlessness.
Inclusion Criteria
Referral to pulmonary services for inability to drain fully via IPC
Presence of a symptomatic septated pleural effusion
A pleural effusion of significant moderate to large volume based on:
* Chest radiograph: effusion filling >= 1/3 of the hemithorax, or
* CT-scan: anteroposterior (AP) depth of the effusion >= 1/3 of the AP dimension on the axial image superior to the hemidiaphragm, including atelectatic lung surrounded by effusion, or
* Ultrasound: effusion spanning at least three intercostal spaces, with a >= 3 cm in at least one intercostal space, while the patient sits upright
Age > 18
Borg score >= 3
Absence of a blocked IPC as demonstrated by a flush with 20 cc of saline x1 without resistance
Presence of septated effusion based on US and chest CT
Exclusion Criteria
Inability to provide informed consent
Study subject has any disease or condition that interferes with safe completion of the study including:
* Uncorrectable coagulopathy based on criteria followed by cardiopulmonary center for procedures
* Active bleeding
* Known allergic reaction to thrombolytics
Pleural effusion is smaller than expected on bedside pre-procedure ultrasound
No septations and/or no loculations on bedside pre-procedure ultrasound
Patient is asymptomatic
Blocked IPC as determined by saline flush
Additional locations may be listed on ClinicalTrials.gov for NCT06184321.
Locations matching your search criteria
United States
Maryland
Baltimore
Johns Hopkins University/Sidney Kimmel Cancer Center
I. To evaluate dyspnea using the Borg score at 48 hours (+/- 12 hours) after treatment with intrapleural alteplase, in patients with symptomatic septated malignant pleural effusion (MPE) and a non-draining/inadequately draining indwelling pleural catheter (IPC).
SECONDARY OBJECTIVE:
I. To evaluate dyspnea using the visual analog scale (VAS) scale at 48 hours (+/- 12 hours) after treatment with intrapleural alteplase, in patients with septated MPE and a nondraining/inadequately draining IPC.
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM I: Patients receive alteplase instilled into the IPC which is capped for 2 hours before the catheter is drained. Patients also undergo computed tomography (CT) throughout the study as well as ultrasound (US) imaging and chest x-ray imaging during follow up.
ARM II: Patients receive placebo instilled into the IPC which is capped for 2 hours before the catheter is drained. Beginning 48 hours later, patients may receive alteplase as in arm I. Patients also undergo CT throughout the study as well as US imaging and chest x-ray imaging during follow up.
After completion of study intervention, patients are followed up at 48 hours.
