Comparison of Intrapleural Urokinase and Video-Assisted Thorascopic Surgery in the Treatment of Parapneumonic Pleural Effusion in Children
NCT ID: NCT02165891
Last Updated: 2018-07-05
Study Results
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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UNKNOWN
PHASE3
40 participants
INTERVENTIONAL
2015-02-28
2020-06-30
Brief Summary
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The purpose of this study is to compare the efficacy and safety of two common technical approach used for pleural effusion drainage in the treatment of childhood empyema.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Urokinase
insertion of a chest drain with urokinase instillation
insertion of a chest drain with urokinase instillation
Other interventions except drainage procedure are the same in both arms
VATS
primary video-assisted thorascopic surgery Other interventions except drainage procedure are the same in both arms
primary video-assisted thorascopic surgery
Interventions
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insertion of a chest drain with urokinase instillation
Other interventions except drainage procedure are the same in both arms
primary video-assisted thorascopic surgery
Eligibility Criteria
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Inclusion Criteria
* pleural fluid depth of at least 15mm, confirmed by ultrasound
* at least one of the following severity criteria :
1. fever continuing 48h after starting correct antibiotherapy
2. respiratory distress
3. mediastinal displacement on the chest X-ray
Exclusion Criteria
* congenital pulmonary disorders with lung function impairment
* chronic pulmonary disease associated with lung function impairment
* hemodynamic instability
* congenital immunodeficiency disease
* secondary immune deficiency induced
* hemostasis disorder (contraindication of thrombolytic therapy)
* pregnancy or breastfeeding patient
1 Year
16 Years
ALL
No
Sponsors
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Queen Fabiola Children's University Hospital
OTHER
Responsible Party
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Locations
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Queen Fabiola University Children Hospital
Brussels, , Belgium
Countries
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Facility Contacts
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Other Identifiers
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P2013/PE1
Identifier Type: -
Identifier Source: org_study_id
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