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Fibrinolysis Compared to Thoracoscopy for Pleural Infection

NCT ID: NCT02973139

Last Updated: 2019-12-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

32 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-07-14

Study Completion Date

2019-11-01

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 complex parapneumonic effusion (CPPE) in adults.

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: 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

Conditions

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Pleural Infection Pleural Diseases

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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Thoracoscopy group

Patients randomized to the Thoracoscopy group will undergo medical thoracoscopy.

Group Type ACTIVE_COMPARATOR

Medical Thoracoscopy

Intervention Type OTHER

Medical thoracoscopy will be performed as per standard protocols.

Fibrinolytic group

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

Group Type ACTIVE_COMPARATOR

Fibrinolytic Group

Intervention Type OTHER

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

Interventions

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Medical Thoracoscopy

Medical thoracoscopy will be performed as per standard protocols.

Intervention Type OTHER

Fibrinolytic Group

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

Intervention Type OTHER

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

Sponsors

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Beth Israel Deaconess Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Adnan Majid

MD FCCP

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Beth Israel Deaconess Medical Center

Boston, Massachusetts, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 32421353 (View on PubMed)

Other Identifiers

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2016P000307

Identifier Type: -

Identifier Source: org_study_id