Clinical trial · Interventional
The Safety and Efficacy of Fibrinolysis in Patients With an Indwelling Pleural Catheter for Multi-loculated Malignant Pleural Effusion.
The Safety and Efficacy of Fibrinolysis in Patients With an Indwelling Pleural Catheter for Multi-loculated Malignant Pleural Effusion: a Prospective Randomized Trial
NCT03678090CI-TRIAL-00043825withdrawnPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Local IRB recommended IND exemption from FDA, study timeline not able to be met.
Summary
Brief summary (as posted)
The safety and efficacy of fibrinolysis in patients with an indwelling pleural catheter for multi-loculated malignant pleural effusion.
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 |
|---|---|---|---|
| Cancer, Lung | Malignant Lung Neoplasm | CURATED_EXACT | 0.92 |
| Pleural Effusion | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| tPA low dosage | Drug | — | UNRESOLVED |
| tPA standard dosage | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- tPA standard dosage
- description
- Tissue Plasminogen Activator (tPA) dose of 10 to 25 mg.
- interventionNames
- Drug: tPA standard dosage
- type
- EXPERIMENTAL
- label
- tPA low dosage
- description
- tPA dose of 2.5mg
- interventionNames
- Drug: tPA low dosage
Primary outcomes (2)
- measure
- Improvement in patient chest X-ray
- timeFrame
- up to 40 days
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Malignant Pleural Effusion MPE (either cytology proven or recurrent exudative pleural effusion in the context of histologically proven cancer) * Presence of an indwelling pleural catheter (IPC) * Nondraining IPC (defined as \<50 mL of drainage on the past three drainage attempts) not responding to routine saline flush to assure patency * Residual pleural fluid remaining on chest x-ray (CXR) or ultrasound * Dyspnea deemed attributable to the effusion (i.e. symptomatic loculations), as assessed by the treating chest physician and using the modified Borg scale * Presence of written informed consent from the patient or surrogate Exclusion Criteria: * Age \<18 * Expected survival less than 14 days * Known allergy or intolerance to tissue plasminogen activator
References
Publications (0)
Data not yet available
No reference posted for this study.