Fibrinolysis Compared to Thoracoscopy for Pleural Infection

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

32 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-11-01

Study Completion Date

2019-12-30

Brief Summary

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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.

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Detailed Description

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Background: Pleural infection (empyema or complex parapneumonic effusion (CPPE)) represents one of the most common clinical diagnoses encountered in clinical practice in the United States (US) It is associated with substantial morbidity and mortality despite advances in medical diagnostic and therapeutic strategies.

Objective: Compare two standard of care treatments: TPA/DNase vs early medical Thoracoscopy

Methods: Investigators will conduct a prospective randomized clinical trial. Plan is to enroll total of 32 patients and randomize those patients to either Medical Thoracoscopy group or Fibrinolytic Therapy group.

Follow-up will be daily until hospital discharge and at 6 and 12 weeks in the outpatient setting

Potential Outcome and Benefit: Determine best strategy for treating patients with pleural infection

Conditions

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Pleural Infection Empyema Pleural Diseases Parapneumonic Effusion

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Fibrinolytic therapy group

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

Group Type ACTIVE_COMPARATOR

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

Intervention Type 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

Medical Thoracoscopy group

Patients randomized to the Thoracoscopy group will undergo medical thoracoscopy.

Group Type ACTIVE_COMPARATOR

Medical Thoracoscopy

Intervention Type PROCEDURE

Medical thoracoscopy will be performed as per standard protocols.

Interventions

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

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

Intervention Type DRUG

Medical Thoracoscopy

Medical thoracoscopy will be performed as per standard protocols.

Intervention Type PROCEDURE

Other Intervention Names

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Pleuroscopy

Eligibility Criteria

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Inclusion Criteria

Subjects \>18 years old with:

Evidence of empyema or complex parapneumonic effusion

Exclusion Criteria

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No