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

Description

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.

Conditions

Hematopoietic and Lymphoid Cell Neoplasm, Malignant Solid Neoplasm

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Study Overview

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Study Details

Study overview

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.

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

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

Condition
Hematopoietic and Lymphoid Cell Neoplasm
Intervention / Treatment

-

Contacts and Locations

Houston

M D Anderson Cancer Center, Houston, Texas, United States, 77030

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • * Draining \< 150 cc and \> 50 cc via IPC at follow up post IPC placement based on patient's drainage record
  • * Presence of septated effusion based on ultrasound (US) and chest CT
  • * 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. This will include patients on anticoagulation that can't be stopped
  • * 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
  • * Inability to undergo CT chest

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

M.D. Anderson Cancer Center,

Horiana Grosu, M D, PRINCIPAL_INVESTIGATOR, M.D. Anderson Cancer Center

Study Record Dates

2027-02-02