Using alteplase to improve fluid drainage and breathlessness in patients with malignant pleural effusion

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study evaluates the effectiveness of alteplase, a medication that dissolves blood clots, in improving pleural fluid drainage and alleviating dyspnea in patients with symptomatic septated malignant pleural effusion who are unable to fully drain fluid through an indwelling pleural catheter. Participants are randomized into two groups: one receiving alteplase and the other receiving a placebo, with assessments of dyspnea conducted using the Borg score and visual analog scale at one week. The study aims to determine if alteplase can enhance symptom management in this patient population.

Why it matters

Who can join: the full rules

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

Where it's running

• M D Anderson Cancer Center
  Houston, Texas, United States Recruiting
• John Hopkins University
  Baltimore, Maryland, United States Not yet recruiting

Study contacts

• Principal investigator: Horiana Grosu, M D — M.D. Anderson Cancer Center
• Study coordinator: Horiana Grosu, M D
• Email: hbgrosu@mdanderson.org
• Phone: 713-792-6238

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.