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

RecruitingEarly phase 1

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

Who can join

Ages 18 and older · All sexes

Full 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

About the study

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.

What is being tested

Sponsor: M.D. Anderson Cancer Center · Participants: 30 · Started: Aug 17, 2023

Contact the study team

Official record on ClinicalTrials.gov — NCT06184321

Locations in the U.S.

MarylandJohn Hopkins University, Baltimore (Not yet recruiting)
TexasM D Anderson Cancer Center, Houston

Conditions

From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.