A Randomized Trial of Alteplase Versus Placebo Through an Indwelling Pleural Catheter for Management of Symptomatic Septated MPE

Status: Recruiting
Location: See location...
Intervention Type: Biological, Drug
Study Type: Interventional
Study Phase: Early Phase 1
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Referral to pulmonary services for inability to drain fully via IPC

• Presence of a symptomatic septated pleural effusion

• A pleural effusion of significant moderate to large volume based on:

‣ Chest radiograph: effusion filling \>= 1/3 of the hemithorax, or

⁃ Computed tomography (CT)-scan: AP depth of the effusion \>= 1/3 of the AP dimension on the axial image superior to the hemidiaphragm, including atelectatic lung surrounded by effusion, or

⁃ Ultrasound: effusion spanning at least three intercostal spaces, with a \>= 3 cm in at least one intercostal space, while the patient sits upright

• Age \> 18

• Borg score \>= 3

• Absence of a blocked IPC as demonstrated by a flush with 20 cc of saline x1 without resistance

• Presence of septated effusion based on ultrasound (US) and chest CT

Locations
United States
Texas
M D Anderson Cancer Center
RECRUITING
Houston
Contact Information
Primary
Horiana Grosu, M D
hbgrosu@mdanderson.org
713-792-6238
Time Frame
Start Date: 2023-08-17
Estimated Completion Date: 2027-02-02
Participants
Target number of participants: 30
Treatments
Experimental: Arm I (alteplase)
Patients receive alteplase instilled into the IPC which is capped for 1-2 hours before the catheter is drained.
Placebo_comparator: Arm II (placebo)
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.
Related Therapeutic Areas
Sponsors
Leads: M.D. Anderson Cancer Center

This content was sourced from clinicaltrials.gov