The Safety and Efficacy of Fibrinolysis in Patients With an Indwelling Pleural Catheter for Multi-loculated Malignant Pleural Effusion.

• Status: Withdrawn
• Trial end date: 2020-02-28
• Target enrollment: 0
• Participant gender: All

Summary

The safety and efficacy of fibrinolysis in patients with an indwelling pleural catheter for multi-loculated malignant pleural effusion.

• Phase: Phase 2
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Yale University
• Treatments: Plasminogen; Tissue Plasminogen Activator

Criteria

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