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

NCT03678090 | Withdrawn Phase 2 DMC

• 1 other identifier: 2000024040
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Pleural Effusion; Cancer, Lung

Outcome Measures

Primary Outcomes (2)

• Improvement in patient chest X-ray

  Defined as change in percentage of hemithorax occupied by the pleural opacity on chest X-ray from the baseline chest X-ray to the X-ray at the end of the study protocol.

  up to 40 days

• Improvement on the modified Borg dyspnea scale after tPA

  Change in modified Borg dyspnea scale obtained at clinic visit where tPA is administered compared to modified Borg dyspnea scale obtained after post-tPA drainage.

  up to 40 days

Secondary Outcomes (3)

• Time to recurrent loculation

  up to 90 days

• Rate of pleurodesis

  up to 90 days

• Improvements in dyspnea using the modified Borg scale

  up to 40 days

Other Outcomes (1)

• Subgroup analysis of patients with trapped lung

  up to 40 days

Study Arms (2)

tPA standard dosage

ACTIVE COMPARATOR

Tissue Plasminogen Activator (tPA) dose of 10 to 25 mg.

Drug: tPA standard dosage

tPA low dosage

EXPERIMENTAL

tPA dose of 2.5mg

Drug: tPA low dosage

Interventions

tPA standard dosage DRUG

Tissue plasminogen activator 25mg dosage

Also known as: tissue plasminogen activator

tPA standard dosage

tPA low dosage DRUG

Tissue plasminogen activator 2.5mg

Also known as: tissue plasminogen activator

tPA low dosage

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Age \<18
• Expected survival less than 14 days
• Known allergy or intolerance to tissue plasminogen activator

Sponsors & Collaborators

• Yale University: lead

MeSH Terms

Conditions

Pleural Effusion; Lung Neoplasms

Interventions

Tissue Plasminogen Activator

Condition Hierarchy (Ancestors)

Pleural Diseases; Respiratory Tract Diseases; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases

Intervention Hierarchy (Ancestors)

Serine Endopeptidases; Endopeptidases; Peptide Hydrolases; Hydrolases; Enzymes; Enzymes and Coenzymes; Serine Proteases; Plasminogen Activators; Blood Coagulation Factors; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Biological Factors

Study Officials

• Mark Godfrey, MD

  Yale University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Masking Details: double blinded
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 18, 2018
• First Posted: September 19, 2018
• Study Start: December 1, 2018
• Primary Completion: February 28, 2020
• Study Completion: February 28, 2020
• Last Updated: March 5, 2020

Record last verified: 2020-03