Alteplase Through an Indwelling Pleural Catheter for the Management of Symptomatic Septated Malignant Pleural Effusion
A Randomized Trial of Alteplase Versus Placebo Through an Indwelling Pleural Catheter for Management of Symptomatic Septated MPE
M.D. Anderson Cancer Center
30 participants
Aug 17, 2023
INTERVENTIONAL
Conditions
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.
Eligibility
Inclusion Criteria10
- 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
- Computed tomography (CT)-scan: 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 ultrasound (US) and chest CT
Exclusion Criteria9
- 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
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Interventions
Instilled into IPC
Instilled into IPC
Locations(1)
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NCT06184321