Fibrinolysis Compared to Thoracoscopy for Pleural Infection

NCT03468933 | Completed Phase 4 Results FDA Drug

• 1 other identifier: 1070390
• Study Type: interventional
• Target: 32
• 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 empyema or complicated parapneumonic effusion (CPPE) in adults.

Conditions

Pleural Infection; Empyema; Pleural Diseases; Parapneumonic Effusion

Outcome Measures

Primary Outcomes (1)

• Duration of Hospital Stay After Intervention

  duration of hospital stay in days from time of procedure to discharge from hospital.

  12 week follow up period

Secondary Outcomes (4)

• Total Length of Hospital Stay

  12 week follow up period

• Number of Participants Necessitating Intervention After the Assigned Treatment

  12 week follow up period

• Adverse Events

  12 week follow up period

• In Hospital and 30-day Mortality

  30 days

Study Arms (2)

Fibrinolytic therapy group

ACTIVE COMPARATOR

Patients randomized to the Fibrinolytic group will receive intrapleural therapy of combined tissue plasminogen activator (tPA) and human recombinant deoxyribonuclease (DNase) via chest tube.

Drug: tissue plasminogen activator (tPA) and human recombinant deoxyribonuclease (DNase)

Medical Thoracoscopy group

ACTIVE COMPARATOR

Patients randomized to the Thoracoscopy group will undergo medical thoracoscopy.

Procedure: Medical Thoracoscopy

Interventions

tissue plasminogen activator (tPA) and human recombinant deoxyribonuclease (DNase) DRUG

Patients will receive intrapleural combination of TPA (10 mg) and DNAse (5 mg). Therapy will be given twice daily for a maximum of 6 dose

Fibrinolytic therapy group

Medical Thoracoscopy PROCEDURE

Medical thoracoscopy will be performed as per standard protocols.

Also known as: Pleuroscopy

Medical Thoracoscopy group

Eligibility Criteria

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

You may qualify if:

• Subjects \>18 years old with:
• Evidence of empyema or complex parapneumonic effusion

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 Hemodynamic instability or severe hypoxemia Non corrected coagulopathy Homogeneously echogenic effusion on pleural ultrasonography

Sponsors & Collaborators

• Tulane University: lead

Study Sites (1)

Tulane Medical Center Tulane University Section of Pulmonary DiseasesTulane University Section of Pulmonary Diseases

New Orleans, Louisiana, 70112, United States

Location

MeSH Terms

Conditions

Empyema; Pleural Diseases

Interventions

Tissue Plasminogen Activator; Thoracoscopy

Condition Hierarchy (Ancestors)

Suppuration; Infections; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; 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; Endoscopy; Diagnostic Techniques, Surgical; Diagnostic Techniques and Procedures; Diagnosis; Minimally Invasive Surgical Procedures; Surgical Procedures, Operative; Thoracic Surgical Procedures

Results Point of Contact

• Title: Dr. Fayez Kheir
• Organization: Tulane University

fkheir@tulane.edu

504-988-3541

Study Officials

• Fayez Kheir, MD, MSc

  Tulane University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, MSc

Study Record Dates

• First Submitted: March 5, 2018
• First Posted: March 19, 2018
• Study Start: November 1, 2017
• Primary Completion: December 30, 2019
• Study Completion: December 30, 2019
• Last Updated: February 4, 2021
• Results First Posted: February 4, 2021

Record last verified: 2021-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)