EUCTR2014-002221-35-BE
Active, not recruiting
Not Applicable
Prospective Randomized Study Comparing the Efficacy and Safety of Pleural Drainage by Video-Assisted Thoracoscopic With Pleural Drain Associated With Urokinase in the Treatment of Parapneumonic Pleural Effusion in Children - UROVATS
Hôpital Universitaire Des Enfants Reine Fabiola0 sitesAugust 1, 2014
ConditionsParapneumonic pleural effusionMedDRA version: 17.0Level: PTClassification code 10071699Term: Infectious pleural effusionSystem Organ Class: 10021881 - Infections and infestationsMedDRA version: 17.0Level: PTClassification code 10014569Term: Empyema drainageSystem Organ Class: 10042613 - Surgical and medical proceduresTherapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]
DrugsActosolv 100 000
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Parapneumonic pleural effusion
- Sponsor
- Hôpital Universitaire Des Enfants Reine Fabiola
- Status
- Active, not recruiting
- Last Updated
- 11 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •\- Eligible ages : 1 year to 15 years
- •\- Eligible genders : both
- •\- 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 shift on the chest X\-ray
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 40
- •F.1\.2 Adults (18\-64 years) no
Exclusion Criteria
- •\- previous drainage by either Video\-Assisted Thoracoscopic or pleural drainage by percutaneous drain with or without fribrinolytic
- •\- congenital pulmonary disorders with lung function impairment
- •\- chronic pulmonary disease associated with lung function impairment
- •\- hemodynamic instability
- •\- acquired immune deficiency
- •\- secondary immune deficiency induced
- •\- coagulopathy disorder (contraindication of thrombolytic therapy)
- •\- pregnancy or breastfeeding patient
Outcomes
Primary Outcomes
Not specified
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