Clinical trial NCT02973139: Fibrinolysis Compared to Thoracoscopy for Pleural Infection
Official title: Fibrinolytic Therapy Versus Medical Thoracoscopy for Treatment of Pleural Infection: A Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pleural Infection
Pleural Diseases
Lead sponsor: Beth Israel Deaconess Medical Center
Sponsor class: OTHER
First posted: 2016-11-25
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 complex parapneumonic effusion (CPPE) in adults.

Detailed description: 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: We will conduct a prospective randomized clinical trial. We plan to enroll a total of 80 patients and randomize them 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

Primary Outcome: Duration of hospital stay after intervention

Secondary Outcome: Failure rate of assigned treatment and adverse events

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

Eligibility criteria: 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

Primary outcomes:
measure: Duration of hospital stay after intervention
timeFrame: 12 week follow up period
Secondary outcomes:
measure: Number of days with chest drainage
timeFrame: 12 week follow up period
measure: Total length of hospital stay
timeFrame: 12 week follow up period
measure: Failure rate of assigned treatment necessitating intervention
timeFrame: 12 week follow up period
measure: Adverse events
timeFrame: 12 week follow up period
measure: In hospital and 30-day mortality
timeFrame: 30 days
measure: Change in pleural fluid volume on Chest CT scan prior to randomization (day 0) to prior to chest tube removal measured by radiologist blinded to treatment allocation using image J software
timeFrame: 12 week follow up period
measure: Inflammatory biomarker (CRP) from randomization (day 0), at 6 weeks and 12 weeks respectively
timeFrame: at randomization and at 6 and12 week follow up visit
measure: Total costs of each treatment modality
timeFrame: 6 and 12 week follow up period
Other outcomes:
Locations:
city: Boston
country: United States
facility: Beth Israel Deaconess Medical Center
state: Massachusetts
Study officials:
References:
citation: 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.