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

Launched by M.D. ANDERSON CANCER CENTER · Dec 14, 2023

Keywords

ClinConnect Summary

This clinical trial is studying whether a medication called alteplase can help patients with a specific type of fluid buildup in the chest, known as malignant pleural effusion, which can cause breathing difficulties. Alteplase is typically used to dissolve blood clots in conditions like heart attacks and strokes, and researchers want to see if it can also improve the drainage of this fluid and reduce breathlessness in patients who have trouble draining it completely.

To participate in the trial, patients need to be over 18 years old and must have a significant pleural effusion that is causing symptoms. They should be experiencing difficulty with fluid drainage despite having an indwelling pleural catheter (a tube to help drain the fluid). However, patients who cannot provide informed consent, have certain bleeding disorders, or are not experiencing symptoms will not be eligible. Participants can expect to receive treatment with alteplase and will be closely monitored for any changes in their symptoms and fluid drainage. This study is currently recruiting patients, and all genders are welcome to participate.

Gender

ALL

Eligibility criteria

• 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
• • 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 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