Clinical trial · Interventional
Tenecteplase (TNK) for Loculated Pleural Effusions in Patients With Malignancy
TNK for Loculated Pleural Effusions in Patients With Malignancy
NCT01580618CI-TRIAL-00108171terminatedPhase 2 / Phase 3Results postedClinicalTrials.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): Unable to accrue patients at a reasonable rate
Summary
Brief summary (as posted)
The objective of the study is to determine the safety and efficacy of TNK infusion for the treatment of loculated pleural effusions in patients with known malignancy compared to normal saline infusion.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Pleural Effusion | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| normal saline | Drug | — | UNRESOLVED |
| TNK (Tenecteplase) | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- PLACEBO_COMPARATOR
- label
- Normal Saline
- description
- Loculated pleural effusion infused with normal saline twice a day for three days.
- interventionNames
- Drug: normal saline
- type
- ACTIVE_COMPARATOR
- label
- TNKase
- description
- Loculated pleural effusion infused with TNK twice a day for three days.
- interventionNames
- Drug: TNK (Tenecteplase)
Primary outcomes (2)
- measure
- Percentage of Patients Achieving Complete or Near Complete Drainage of Loculated Pleural Effusion as Determined From Chest Radiography After Three Days or Five Days of Intrapleural Therapy.
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 85 Years
Show eligibility criteria text
Inclusion Criteria: * Ability to provide written informed consent and comply with study assessments for the full duration of the study. * Age \> 18 years * Adult, non-gravid patients with malignancy and symptomatic loculated pleural effusion who has undergone percutaneous drainage will be eligible to participate. A loculated effusion is defined as an effusion whose contents cannot be completely drained at the time of initial catheter placement as documented by the initial imaging guided procedure or within 48 hours of catheter placement by chest radiography. Malignant cells need not be found within the pleural fluid. Exclusion Criteria: * Active internal bleeding, involving intracranial and retroperitoneal sites, or the gastrointestinal, genitourinary, or respiratory tracts * History of stroke within 3 months * Intracranial neoplasm, arteriovenous malformation, or aneurysm. * Uncorrectable bleeding diathesis (INR \> 1.5 despite therapy) * Recent intracranial or intraspinal surgery or trauma * Pregnancy (positive pregnancy test) * Severe uncontrolled hypertension * Documented empyema * Any other condition that the investigator believes would pose a significant hazard to the subject if the investigational therapy were initiated * Participation in another simultaneous medical investigation or trial * Participation in another clinical investigation within previous 30 days of catheter placement * Prior enrollment in the study * Known allergy to TNK or any of its components
References
Publications (0)
Data not yet available
No reference posted for this study.