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Urokinase Versus Video-assisted Thoracoscopic to Treat Complicated Parapneumonic Empyema in Childhood

Information source: Spanish Society of Pediatric Surgery
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Empyema; Pneumonia

Intervention: Urokinase (Drug); Video-Assisted Thoracoscopic (Procedure)

Phase: Phase 3

Status: Completed

Sponsored by: Spanish Society of Pediatric Surgery


A great controversy exists about which is the best method to perform the evacuation of the collection. The purpose of this study is to evaluate which is the best initial treatment to drain complicated parapneumonic empyema (stages II and III) in children: the present study raises a hypothesis of equivalence between both arms of treatment (chest drainage plus intrapleural urokinase or videothoracoscopic debridement).

Clinical Details

Official title: Exploratory Multicentre Clinical Trial to Compare the Efficacy of Urokinase Versus Video-assisted Thoracoscopic for Treatment of Complicated Parapneumonic Empyema in Childhood

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: duration of the hospital stay after the treatment

Secondary outcome:

complications of the treatment and complications of the disease

total duration of the hospital stay

number of days carrying the chest drain

duration of the fever once the empyema has been drained


Minimum age: 1 Year. Maximum age: 15 Years. Gender(s): Both.


Inclusion Criteria:

- Patients less than 15 years of age with pneumonia and persistent fever, and

complicated parapneumonic empyema (septation or loculation seen on ultrasound or Rx thorax)stages II and III requiring an intervention to drain Exclusion Criteria:

- Existing contraindications or other previous conditions, hypertension, pneumothorax

Locations and Contacts

University Hospital Vall d'Hebron, Barcelona 08035, Spain

Hospital Gregorio Marañón, Madrid, Spain

Hospital Infantil La Paz, Madrid, Spain

Hospital Universitario 12 de Octubre, Madrid, Spain

Hospital Universitario Central de Asturias, Oviedo, Asturias, Spain

Hospital de Donostia, San Sebastián, Donostia 20014, Spain

Additional Information

Starting date: July 2008
Last updated: October 27, 2010

Page last updated: August 23, 2015

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