Actively Recruiting
A Randomized Trial of Alteplase Versus Placebo Through an Indwelling Pleural Catheter for Management of Symptomatic Septated Malignant Pleural Effusion
Led by M.D. Anderson Cancer Center · Updated on 2025-12-26
30
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying whether alteplase, a medicine that helps dissolve blood clots, can improve the drainage of pleural fluid and ease breathlessness in patients with non-draining malignant pleural effusion (MPE) that has septations. This early phase 1 trial focuses on patients who have an indwelling pleural catheter (IPC) that is not draining properly due to septated fluid collections. The goal is to see if alteplase can help improve symptoms and fluid drainage compared to a placebo. Participants are randomly assigned to one of two groups. In one group, patients receive alteplase instilled into their IPC, which is then capped for 1 to 2 hours before draining the catheter. The other group receives a placebo in the same way, with the option to receive alteplase starting one week later. The study follows patients until the catheter is removed or they pass away. During the study, researchers regularly assess breathlessness using visual analog and Borg scales at several time points: 48 hours, 1 week, 2 weeks, and every 4 weeks after treatment. They also monitor complications, quality-adjusted survival, and adverse events based on standard criteria. The overall study participation may last about one year with ongoing evaluations to understand the effects and safety of alteplase in this setting.
CONDITIONS
Brief Title
Alteplase Through an Indwelling Pleural Catheter for the Management of Symptomatic Septated Malignant Pleural Effusion
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Referral to pulmonary services for inability to drain fully via indwelling pleural catheter (IPC)
- Presence of a symptomatic septated pleural effusion
- Moderate to large pleural effusion shown by chest X-ray, CT scan, or ultrasound
- Age greater than 18 years
- Borg score of 3 or higher for breathlessness
- No blocked IPC as shown by a saline flush without resistance
- Septated effusion confirmed by ultrasound and chest CT
You will not qualify if you...
- Inability to provide informed consent
- Any disease or condition that prevents safe participation, including uncorrectable coagulopathy, active bleeding, or known allergy to thrombolytics
- Pleural effusion smaller than expected on ultrasound before procedure
- No septations or loculations seen on ultrasound before procedure
- Patient has no symptoms
- Blocked IPC confirmed by saline flush
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 1 year or until catheter removal or death
Participants receive alteplase or placebo instilled into the indwelling pleural catheter (IPC), which is capped for 1-2 hours before the catheter is drained. Participants in the placebo arm may receive alteplase starting 1 week later.
Initial treatment visit and follow-up visits every 1 to 4 weeks until catheter removal or death
Trial Site Locations
Total: 1 location
1
M D Anderson Cancer Center
Houston, Texas, United States, 77030
Actively Recruiting
Research Team
H
Horiana Grosu, M D
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
2
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