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A randomized trial of alteplase versus placebo through an indwelling pleural catheter for management of non-draining malignant pleural effusions

Details

Status

open

Study Type

Interventional

Study Phase

I

Location(s)

Johns Hopkins Bayview Medical Center

4940 Eastern Ave Baltimore, MD 21224

The Johns Hopkins Hospital

1800 Orleans St Baltimore, MD 21287

Contact Us

(410) 955-8964

Brief Summary

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.

Eligibility

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