A randomized trial of alteplase versus placebo through an indwelling pleural catheter for management of non-draining malignant pleural effusions
Details
Status
Open: Currently recruiting participants.
Closed: Recruitment either has not started or has paused or completed.
Study Type
Interventional (clinical trials): Test treatments.
Observational: Conduct surveys and interviews, study medical records and otherwise observe people or groups over time.
Interventional
Study Phase
Each study phase tests different aspects of the medication or treatment:
- Phase I: safety and dosing
- Phase II: effectiveness and side effects
- Phase III: efficacy compared to standard treatments
- Phase IV: long-term safety after approval for use
I
Location(s)
Johns Hopkins study sites. Additional study locations may be found on ClinicalTrials.gov.
Johns Hopkins Bayview Medical Center
4940 Eastern Ave Baltimore, MD 21224
The Johns Hopkins Hospital
1800 Orleans St Baltimore, MD 21287
Contact Us
(410) 955-8964Brief 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