NCT06184321

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

• Status: Recruiting
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: M.D. Anderson Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

PRIMARY OBJECTIVE: I. To evaluate dyspnea using the visual analog scale (VAS) scale at one week in patients with symptomatic septated malignant neoplasm of the pleural effusion (MPE) and a non-draining/inadequately draining indwelling pleural catheter (IPC). SECONDARY OBJECTIVE: I. To evaluate dyspnea using the visual analog scale (VAS) scale at 48 hours (+/-12 hours) after treatment with intrapleural alteplase, in patients with septated MPE and a nondraining/inadequately draining IPC. In addition, complications, quality adjusted survival (calculated using the SF-6D to determine utilities and then integrating utilities over time to arrive at quality-adjusted survival), change in dyspnea (using the Borg score and VAS scale) at 1 week (+/- 1 day), 2 weeks (+/- 2 days) and every 4 weeks (+/- 2 days) after the intervention until IPC removal or death. OUTLINE: Patients are randomized to 1 of 2 arms. ARM I: Patients receive alteplase instilled into the IPC which is capped for 1-2 hours before the catheter is drained. ARM II: 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.

Conditions

• Hematopoietic and Lymphoid Cell Neoplasm
• Malignant Solid Neoplasm

Interventions

Type	Name	Description
BIOLOGICAL	Alteplase	Instilled into IPC
DRUG	Placebo Administration	Instilled into IPC

Timeline

• Start date: 2023-08-17
• Primary completion: 2027-02-02
• Completion: 2027-02-02
• First posted: 2023-12-28
• Last updated: 2025-12-26

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study