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
Summary
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 diseasetotal duration of the hospital stay number of days carrying the chest drain duration of the fever once the empyema has been drained
Eligibility
Minimum age: 1 Year.
Maximum age: 15 Years.
Gender(s): Both.
Criteria:
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
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