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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Hematopoietic and Lymphoid Cell Neoplasm; Malignant Solid Neoplasm
• Intervention / Treatment: Biological: Alteplase; Drug: Placebo Administration

Detailed Description

PRIMARY OBJECTIVE:

I. To evaluate dyspnea using the Borg score at one week in patients with symptomatic septated malignant pleural effusion (MPE) and indwelling pleural catheter (IPC) with inability to drain fully that are treated with intrapleural alteplase.

SECONDARY OBJECTIVE:

I. To evaluate dyspnea using the visual analog scale (VAS) scale at one week in patients with septated MPE and IPC and inability to drain fully that are treated with intrapleural alteplase.

OUTLINE: Patients are randomized to 1 of 2 arms.

ARM I: Patients receive alteplase instilled into the IPC which is capped for 1-2 hours before the catheter is drained.

ARM II: Patients receive placebo instilled into the IPC which is capped for 1-2 hours before the catheter is drained. Beginning 1 week later, patients may receive alteplase as in arm I.

• Study Type: Observational
• Enrollment (Estimated): 30

Contacts and Locations

• Study Contact: Name: Horiana Grosu, M D; Phone Number: 713-792-6238; Email: hbgrosu@mdanderson.org

Study Locations

• United States
  • Texas
    • Houston, Texas, United States, 77030
      • Recruiting
      • M D Anderson Cancer Center
      • Principal Investigator: Horiana Grosu, MD
      • Contact: Horiana Grosu, MD; Phone Number: 713-792-6238; Email: hbgrosu@mdanderson.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients with MPE and IPC in place referred to outpatient or inpatient pulmonology for inability to drain fully their fluid

Description

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
• 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

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. 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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Arm I (alteplase); Patients receive alteplase instilled into the IPC which is capped for 1-2 hours before the catheter is drained.	Biological: Alteplase; Instilled into IPC; Other Names: Activase; r-tPA; rt-PA; Plasminogen Activator (Human Tissue-Type Protein Moiety); Recombinant Tissue Plasminogen Activator
Arm II (placebo); Patients receive placebo instilled into the IPC which is capped for 1-2 hours before the catheter is drained. Beginning 1 week later, patients may receive alteplase as in arm I.	Drug: Placebo Administration; Instilled into IPC

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events	through study completion; an average of 1 year

Collaborators and Investigators

• Sponsor: M.D. Anderson Cancer Center
• Investigators: Principal Investigator: Horiana Grosu, M D, M.D. Anderson Cancer Center

Publications and helpful links

Helpful Links

• M D Anderson Cancer Center

Study record dates

Study Major Dates

• Study Start (Actual): August 17, 2023
• Primary Completion (Estimated): February 2, 2027
• Study Completion (Estimated): February 2, 2027

Study Registration Dates

• First Submitted: December 14, 2023
• First Submitted That Met QC Criteria: December 14, 2023
• First Posted (Actual): December 28, 2023

Study Record Updates

• Last Update Posted (Actual): December 28, 2023
• Last Update Submitted That Met QC Criteria: December 14, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Molecular Mechanisms of Pharmacological Action; Fibrinolytic Agents; Fibrin Modulating Agents; Tissue Plasminogen Activator; Plasminogen
• Other Study ID Numbers: 2021-0554 (Other Identifier: M D Anderson Cancer Center); NCI-2021-09122 (Registry Identifier: CTRP (Clinical Trial Reporting Program))

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No