Fibrinolytic Therapy Versus Medical Thoracoscopy

NCT03213834 | Completed Phase 4 Results FDA Drug

• 1 other identifier: IRB201700012
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this prospective randomized clinical trial is to compare two currently accepted standard-of-care treatment strategies: medical thoracoscopy as compared to instillation of intrapleural tissue plasminogen activator (TPA) and human recombinant deoxyribonuclease (DNase) for the management of complicated pleural infections in adults as defined as complicated parapneumonic effusions or pleural empyema.

Conditions

Pleural Diseases

Outcome Measures

Primary Outcomes (1)

• Number of Hospital Days for Required to Treat Complicated Parapneumonic Effusions or Pleural Empyema.

  Time between initiation of treatment and hospital discharge

  30 days starting on day of admission

Secondary Outcomes (5)

• Duration of Chest Tube

  30 days starting on day of admission

• Duration of Entire Hospital Stay for Complete Treatment of Pleural Infection

  30 days starting on day of admission

• Treatment Failure

  30 days starting on day of admission

• Number of Participants With Adverse Events

  30 days starting on day of admission

• Mortality

  30 days starting on day of admission

Study Arms (2)

Thoracoscopy Arm

ACTIVE COMPARATOR

Consisting of chest thoracoscopy

Procedure: Chest thoracoscopy

Fibrinolytic Therapy Arm

ACTIVE COMPARATOR

Consisting of chest fibrinolytic therapy

Procedure: Chest fibrinolytic therapy; Drug: tPA; Drug: DNase

Interventions

Chest thoracoscopy PROCEDURE

Thoracoscopy will be performed as per standard protocols, with patient lateral decubitus position. Ten mLs of fluid will be collected to check for biomarkers. Adhesiolysis will be attempted and pleural irrigation will be done. At the end of the procedure, a drain will be inserted and connected to an underwater seal with a negative pressure suction

Thoracoscopy Arm

Chest fibrinolytic therapy PROCEDURE

A chest tube will be inserted under ultrasonography into the most dependent area of the pleural effusion or into the largest loculation in patients with multi-loculated effusions. A of DNase and tPA will be given. Concurrent tPA and DNase will be administered intrapleurally through the chest tube followed by saline flush. The tube will then be clamped for 120 minutes and after which it will be connected back to wall suction. The intrapleural therapy will be given twice daily for a maximum of 6 doses.

Fibrinolytic Therapy Arm

tPA DRUG

tPA administered intrapleurally through the chest tube followed by saline flush. The intrapleural therapy will be given twice daily for a maximum of 6 doses.

Also known as: Actilyse

Fibrinolytic Therapy Arm

DNase DRUG

DNase administered intrapleurally through the chest tube followed by saline flush. The intrapleural therapy will be given twice daily for a maximum of 6 doses.

Also known as: pulmozyme

Fibrinolytic Therapy Arm

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• CPPE along with evidence of septated pleural effusion on pleural ultrasonography and/or chest CT scan
• empyema.

You may not qualify if:

• age \<18 years;
• Pregnancy
• inability to give informed written consent;
• previous thoracic surgery or thrombolytic therapy for pleural infection;
• medical thoracoscopy cannot be performed within 48 hours;
• inability to tolerate procedure due to hemodynamic instability or severe hypoxemia;
• inability to correct coagulopathy;
• presence of a homogeneously echogenic effusion on pleural US27 -

Sponsors & Collaborators

• University of Florida: lead

Study Sites (1)

University of Florida

Gainesville, Florida, 32611, United States

Location

Related Publications (1)

• Kheir F, Thakore S, Mehta H, Jantz M, Parikh M, Chee A, Kaphle U, Sisnega C, Fernandez-Bussy S, Majid A. Intrapleural Fibrinolytic Therapy versus Early Medical Thoracoscopy for Treatment of Pleural Infection. Randomized Controlled Clinical Trial. Ann Am Thorac Soc. 2020 Aug;17(8):958-964. doi: 10.1513/AnnalsATS.202001-076OC.

  PMID: 32421353 RESULT

MeSH Terms

Conditions

Pleural Diseases

Interventions

Tissue Plasminogen Activator; Deoxyribonucleases; dornase alfa

Condition Hierarchy (Ancestors)

Respiratory Tract 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; Esterases

Results Point of Contact

• Title: Erin Silverman, Research Coordinator
• Organization: University of Florida

erin.silverman@medicine.ufl.edu

352-273-5870

Study Officials

• Hiren Mehta, MD

  University of Florida

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Change in pleural fluid volume on chest CT scan from randomization (day 0) to prior to chest tube removal will be measured by a radiologist blinded to treatment allocation using image J software
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Subjects will be randomly assigned to receive one of two standard-of-care treatments for severe pleural infection.

Study Record Dates

• First Submitted: July 7, 2017
• First Posted: July 11, 2017
• Study Start: September 14, 2017
• Primary Completion: February 4, 2020
• Study Completion: February 4, 2020
• Last Updated: February 20, 2024
• Results First Posted: February 20, 2024

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)