Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 4:49 AM
Ignite Modification Date:
2025-12-25 @ 4:49 AM
NCT ID:
NCT01580618
Eligibility Criteria:
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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01580618
Study Brief:
Protocol Section:
NCT01580618