Clinical trial · Interventional
Alteplase Through an Indwelling Pleural Catheter for the Management of Symptomatic Septated Malignant Pleural Effusion
A Randomized Trial of Alteplase Versus Placebo Through an Indwelling Pleural Catheter for Management of Symptomatic Septated MPE
NCT06184321CI-TRIAL-00122370recruitingEarly Phase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Hematopoietic and Lymphoid Cell Neoplasm | Hematopoietic and Lymphoid Cell Neoplasm | ONTOLOGY_EXACT | 0.98 |
| Malignant Solid Neoplasm | Malignant Solid Neoplasm | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Alteplase | Biological | — | UNRESOLVED |
| Placebo Administration | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Arm I (alteplase)
- description
- Patients receive alteplase instilled into the IPC which is capped for 1-2 hours before the catheter is drained.
- interventionNames
- Biological: Alteplase
- type
- PLACEBO_COMPARATOR
- label
- Arm II (placebo)
- description
- 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.
- interventionNames
- Drug: Placebo Administration
Primary outcomes (1)
- measure
- Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.