RECRUITING

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

Conditions

Hematopoietic and Lymphoid Cell Neoplasm Malignant Solid Neoplasm

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

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

Quick Facts

Study Start:2023-08-17

Study Completion:2027-02-02

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06184321

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.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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

Inclusion Criteria

Exclusion 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

Contacts and Locations

Study Contact

Horiana Grosu, M D

CONTACT

713-792-6238

hbgrosu@mdanderson.org

Principal Investigator

Horiana Grosu, M D

PRINCIPAL_INVESTIGATOR

M.D. Anderson Cancer Center

Study Locations (Sites)

M D Anderson Cancer Center

Houston, Texas, 77030

United States

Collaborators and Investigators

Sponsor: M.D. Anderson Cancer Center

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

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-08-17

Study Completion Date2027-02-02

Study Record Updates

Study Start Date2023-08-17

Study Completion Date2027-02-02

Terms related to this study

Additional Relevant MeSH Terms

Hematopoietic and Lymphoid Cell Neoplasm
Malignant Solid Neoplasm