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Recruiting NCT06184321

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

Early Phase I Interventional Hematopoietic and Lymphoid Cell Neoplasm Malignant Solid Neoplasm

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Alteplase, Placebo Administration.
Who it may be relevant to
Registry conditions: Hematopoietic and Lymphoid Cell Neoplasm, Malignant Solid Neoplasm. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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

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.

Detailed description

PRIMARY OBJECTIVE:

I. To evaluate dyspnea using the visual analog scale (VAS) scale at one week in patients with symptomatic septated malignant neoplasm of the pleural effusion (MPE) and a non-draining/inadequately draining indwelling pleural catheter (IPC).

SECONDARY OBJECTIVE:

I. To evaluate dyspnea using the visual analog scale (VAS) scale at 48 hours (+/-12 hours) after treatment with intrapleural alteplase, in patients with septated MPE and a nondraining/inadequately draining IPC. In addition, complications, quality adjusted survival (calculated using the SF-6D to determine utilities and then integrating utilities over time to arrive at quality-adjusted survival), change in dyspnea (using the Borg score and VAS scale) at 1 week (+/- 1 day), 2 weeks (+/- 2 days) and every 4 weeks (+/- 2 days) after the intervention until IPC removal or death.

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.

Interventions

  • Biological Alteplase
    Instilled into IPC
  • Drug Placebo Administration
    Instilled into IPC

Primary outcome measures

  • Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events [Time frame: through study completion; an average of 1 year]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

United States · 1 center
  • M D Anderson Cancer Center — Houston

Identifiers

NCT: NCT06184321 · 2021-0554 · NCI-2021-09122 · 2021-0554

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗