Alteplase Through an Indwelling Pleural Catheter for the Management of Symptomatic Septated Malignant Pleural Effusion

Malignant Solid Neoplasm Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06184321
• Other study ID #: 2021-0554
• Secondary ID: NCI-2021-0912220
• Status: Recruiting
• Start date: August 17, 2023
• Est. completion date: February 2, 2027

Study information

• Verified date: December 2023
• Source: M.D. Anderson Cancer Center
• Contact: Horiana Grosu, M D
• Phone: 713-792-6238
• Email: hbgrosu[@]mdanderson.org
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Description:

PRIMARY OBJECTIVE: I. To evaluate dyspnea using the Borg score at one week in patients with symptomatic septated malignant pleural effusion (MPE) and indwelling pleural catheter (IPC) with inability to drain fully that are treated with intrapleural alteplase. SECONDARY OBJECTIVE: I. To evaluate dyspnea using the visual analog scale (VAS) scale at one week in patients with septated MPE and IPC and inability to drain fully that are treated with intrapleural alteplase. 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: February 2, 2027
• Est. primary completion date: February 2, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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
• Draining < 150 cc and > 50 cc via IPC at follow up post IPC placement based on patient's drainage record
• Presence of septated effusion based on ultrasound (US) and chest CT

Exclusion Criteria:

• Inability to provide informed consent
• Study subject has any disease or condition that interferes with safe completion of the

study including:

• Uncorrectable Coagulopathy based on criteria followed by cardiopulmonary center for procedures. This will include patients on anticoagulation that can't be stopped
• Active bleeding
• Known allergic reaction to thrombolytics
• Pleural effusion is smaller than expected on bedside pre-procedure ultrasound
• No septations and/or no loculations on bedside pre-procedure ultrasound
• Patient is asymptomatic
• Blocked IPC as determined by saline flush
• Inability to undergo CT chest

Related Conditions & MeSH terms

• Hematopoietic and Lymphoid Cell Neoplasm
• Malignant Solid Neoplasm
• Neoplasms

Intervention

Biological:
• Alteplase
Instilled into IPC

Drug:
• Placebo Administration
Instilled into IPC

Locations

Country	Name	City	State
United States	M D Anderson Cancer Center	Houston	Texas

Sponsors (1)

Lead Sponsor	Collaborator
M.D. Anderson Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events		through study completion; an average of 1 year

External Links

•   M D Anderson Cancer Center