Using alteplase to improve fluid drainage and breathlessness in patients with malignant pleural effusion
A Randomized Trial of Alteplase Versus Placebo Through an Indwelling Pleural Catheter for Management of Symptomatic Septated MPE
This study tests if the medication alteplase can help people with fluid buildup in the lungs feel better and breathe easier when regular drainage isn’t enough.
Quick facts
| Phase | Early Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | M.D. Anderson Cancer Center Academic / other |
| Locations | 1 site (Houston, Texas) |
| Trial ID | NCT06184321 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effectiveness of alteplase, a medication that dissolves blood clots, in improving pleural fluid drainage and alleviating dyspnea in patients with symptomatic septated malignant pleural effusion who are unable to fully drain fluid through an indwelling pleural catheter. Participants are randomized into two groups: one receiving alteplase and the other receiving a placebo, with assessments of dyspnea conducted using the Borg score and visual analog scale at one week. The study aims to determine if alteplase can enhance symptom management in this patient population.
Who should consider this trial
Good fit: Ideal candidates include adults over 18 with symptomatic septated malignant pleural effusion who are unable to drain fluid adequately through an indwelling pleural catheter.
Not a fit: Patients who cannot provide informed consent or have a blocked indwelling pleural catheter may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly improve the quality of life for patients suffering from breathlessness due to malignant pleural effusion.
How similar studies have performed: While the use of alteplase in this specific context is novel, similar approaches in other settings have shown promise in improving fluid drainage and symptom relief.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Houston, Texas
- M D Anderson Cancer Center — Houston, Texas, United States (Recruiting)
Study contacts
- Principal investigator: Horiana Grosu, M D — M.D. Anderson Cancer Center
- Study coordinator: Horiana Grosu, M D
- Email: hbgrosu@mdanderson.org
- Phone: 713-792-6238
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.